Analyzer, Gas, Nitrogen, Partial Pressure, Blood-Phase, Non-Indwelling
Needle, Conduction, Anesthetic (W/Wo Introducer)
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.p
Humidifier, Respiratory Gas, (Direct Patient Interface)
Calculator, Predicted Values, Pulmonary Function
Analyzer, Gas, Water Vapor, Gaseous-Phase
Rhinoanemometer (Measurement Of Nasal Decongestion)
Meter, Airway Pressure (Inspiratory Force)
Condenser, Heat And Moisture (Artificial Nose)
Attachment, Breathing, Positive End Expiratory Pressure
Mask, Oxygen, Low Concentration, Venturi
Chair, Posture, For Cardiac And Pulmonary Treatment
Oxygenator, Long Term Support Greater Than 6 Hours
Ventilator, External Body, Negative Pressure, Adult (Cuirass)
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Calculator, Pulmonary Function Interpretator (Diagnostic)
Cart, Emergency, Cardiopulmonary (Excluding Equipment)
Set, Tubing And Support, Ventilator (W Harness)
Mixer, Breathing Gases, Anesthesia Inhalation
Stethoscope, Esophageal, With Electrical Conductors
Circuit, Breathing (W Connector, Adaptor, Y Piece)
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
Monitor, Spinal-Fluid Pressure, Electrically Powered
Flowmeter, Tube, Thorpe, Back-Pressure Compensated
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance ab
Bottle, Collection And Trap, Breathing System (Uncalibrated)
Bottle, Collection, Breathing System (Calibrated)
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Attachment, Intermitant Mandatory Ventilation (Imv)
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance ab
Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling
Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling
Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling
Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge
Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
Urease And Glutamic Dehydrogenase, Urea Nitrogen
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase
Ammonium Molybdate And Ammonium Vanadate, Phospholipids
Olive Oil Emulsion (Turbidimetric), Lipase
Chromatographic Separation, Lactate Dehydrogenase Isoenzymes
Immunoelectrophoretic, Immunoglobulins, (G, A, M)
Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase
Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
Method, Nephelometric, Immunoglobulins (G, A, M)
Radioimmunoassay, Immunoglobulins (G, A, M)
Electrode, Ion Based, Enzymatic, Creatinine
Method, Immunodiffusion, Immunoglobulins (G, A, M)
Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
Titrimetric Permanganate And Bromophenol Blue, Calcium
Mercuric Nitrate And Diphenyl Carbazone (Titrimetric), Chloride
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Radioimmunoassay, Total Estrogens In Pregnancy
Titrimetric With Edta And Indicator, Calcium
Radioimmunoassay, Angiotensin I And Renin
Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes
Fructose-1, 6-Diphosphate And Nadh (U.V.), Aldolase
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Thymol Blue Monophosphate, Alkaline Phosphatase Or Isoenzymes
Disodium Phenylphosphate, Alkaline Phosphatase Or Isoenzymes
Phenolphthalein Phosphate, Alkaline Phosphatase Or Isoenzymes
Beta Glycerophosphate, Alkaline Phosphatase Or Isoenzymes
Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes
Acid Phosphatase, Thymol Blue Monophosphate
Phenylphosphate, Alkaline Phosphatase Or Isoenzymes
Iga, Rhodamine, Antigen, Antiserum, Control
Iga, Peroxidase, Antigen, Antiserum, Control
Iga, Ferritin, Antigen, Antiserum, Control
Inter-Alpha Trypsin Inhibitor, Antigen, Antiserum, Control
Bence-Jones Protein, Antigen, Antiserum, Control
Hemopexin, Rhodamine, Antigen, Antiserum, Control
Retinol-Binding Protein, Antigen, Antiserum, Control
Hemopexin, Fitc, Antigen, Antiserum, Control
Complement C3, Antigen, Antiserum, Control
Complement C1s, Antigen, Antiserum, Control
Haptoglobin, Rhodamine, Antigen, Antiserum, Control
Igg, Peroxidase, Antigen, Antiserum, Control
Haptoglobin, Fitc, Antigen, Antiserum, Control
Complement C3b Activator, Antigen, Antiserum, Control
Complement C9, Antigen, Antiserum, Control
Gamma Globulin, Fitc, Antigen, Antiserum, Control
Complement C8, Antigen, Antiserum, Control
Gamma Globulin, Antigen, Antiserum, Control
Complement C1r, Antigen, Antiserum, Control
Free Secretory Component, Antigen, Antiserum, Control
Complement C1q, Antigen, Antiserum, Control
Fraction Iv-5, Antigen, Antiserum, Control
Hemoglobin, Chain Specific, Antigen, Antiserum, Control
Fibrinopeptide A, Antigen, Antiserum, Control
Igm (Mu Chain Specific), Antigen, Antiserum, Control
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Igg (Fd Fragment Specific), Antigen, Antiserum, Control
Fibrinogen And Split Products, Rhodamine, Antigen, Antiserum, Control
Igg (Fc Fragment Specific), Antigen, Antiserum, Control
Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control
Fibrinogen And Split Products, Fitc, Antigen, Antiserum, Control
Complement C5, Antigen, Antiserum, Control
Fibrinogen And Split Products, Antigen, Antiserum, Control
Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control
Alpha 2, 2n-Glycoprotein, Antigen, Antiserum, Control
Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control
Fc, Rhodamine, Antigen, Antiserum, Control
Complement C4, Antigen, Antiserum, Control
Antiparietal Antibody, Indirect Immunofluorescent, Antigen, Control
Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Factor Xiii A, S, Antigen, Antiserum, Control
Fab, Rhodamine, Antigen, Antiserum, Control
System, Test, C-Reactive Protein, Rhodamine
C-Reactive Protein, Antigen, Antiserum, And Control
Ceruloplasmin, Rhodamine, Antigen, Antiserum, Control
Ceruloplasmin, Fitc, Antigen, Antiserum, Control
Transferrin, Rhodamine, Antigen, Antiserum, Control
Carbonic Anhydrase C, Antigen, Antiserum, Control
Carbonic Anhydrase B, Antigen, Antiserum, Control
Transferrin, Fitc, Antigen, Antiserum, Control
Thyroglobulin, Fitc, Antigen, Antiserum, Control
Beta-2-Glycoprotein Iii, Antigen, Antiserum, Control
Thyroglobulin, Rhodamine, Antigen, Antiserum, Control
Beta-2-Glycoprotein I, Antigen, Antiserum, Control
Myoglobin, Rhodamine, Antigen, Antiserum, Control
Antigen, Antiserum, Control, Antithrombin Iii
Prealbumin, Fitc, Antigen, Antiserum, Control
Alpha-2-Macroglobulin, Rhodamine, Antigen, Antiserum, Control
Alpha-2-Macroglobulin, Fitc, Antigen, Antiserum, Control
Albumin, Fitc, Antigen, Antiserum, Control
Myoglobin, Fitc, Antigen, Antiserum, Control
Inter-Alpha Trypsin Inhibitor, Fitc, Antigen, Antiserum, Control
Alpha-1-Antitrypsin, Fitc, Antigen, Antiserum, Control
Kappa, Rhodamine, Antigen, Antiserum, Control
Lipoprotein X, Antigen, Antiserum, Control
Kappa, Fitc, Antigen, Antiserum, Control
Lambda, Peroxidase, Antigen, Antiserum, Control
Lambda, Fitc, Antigen, Antiserum, Control
Lactic Dehydrogenase, Antigen, Antiserum, Control
Igm, Peroxidase, Antigen, Antiserum, Control
Igm, Rhodamine, Antigen, Antiserum, Control
Alpha-1-Antitrypsin, Rhodamine, Antigen, Antiserum, Control
Lipoprotein, Low-Density, Antigen, Antiserum, Control
Kappa, Peroxidase, Antigen, Antiserum, Control
Lambda, Rhodamine, Antigen, Antiserum, Control
Total Spinal-Fluid, Antigen, Antiserum, Control
Albumin, Rhodamine, Antigen, Antiserum, Control
Igg (Fab Fragment Specific), Antigen, Antiserum, Control
Igm, Ferritin, Antigen, Antiserum, Control
Ige, Ferritin, Antigen, Antiserum, Control
Igg, Rhodamine, Antigen, Antiserum, Control
Sperm, Fitc, Antigen, Antiserum, Control
Igg (Gamma Chain Specific), Antigen, Antiserum, Control
Cohn Fraction Ii, Antigen, Antiserum, Control
Seminal Fluid, Antigen, Antiserum, Control
Igg, Ferritin, Antigen, Antiserum, Control
Igd, Rhodamine, Antigen, Antiserum, Control
Igd, Peroxidase, Antigen, Antiserum, Control
Breast Milk, Rhodamine, Antigen, Antiserum, Control
Ige, Rhodamine, Antigen, Antiserum, Control
Breast Milk, Antigen, Antiserum, Control
Breast Milk, Fitc, Antigen, Antiserum, Control
Ige, Peroxidase, Antigen, Antiserum, Control
Whole Blood Plasma, Antigen, Antiserum, Control
Whole Human Serum, Antigen, Antiserum, Control
System, Test, Human Chorionic Gonadotropin
System, Test, Radioallergosorbent (Rast) Immunological
System, Test, Systemic Lupus Erythematosus
Protein, Complement, Antigen, Antiserum, Control
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Bacillus Subtlis Microbiology Assay, Tobramycin
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Radioimmunoassay, Morphine (3-H), Goat Antibody Ammonium Sulfate Sep.
Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep.
Bacillus Subtlis, Microbiological Assay, Gentamicin
Test Reagents For Sulphanimide Derivatives
Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase
Gas Chromatograph, Alcohol (Dedicated Instruments)
Potassium Dichromate Specific Reagent For Alcohol
Nad-Nadh, Specific Reagent For Alcohol Enzyme Method
Solution, M-Nitrophenol, Specific Reagent For Cholinesterase
Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet
Radioimmunoassay, Morphine-Barbiturate (125-I), Goat Antibody
Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Solid Phase Sep.
Radioimmunoassay, Digoxin (125-I), Goat Antibody, 2nd Antibody Sep.
Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Sep.
Radioimmunoassay, Digoxin (3-H), Rabbit Antibody, Coated Tubes Sep.
Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Double Label Sep.
Radioimmunoassay, Digitoxin (3-H), Rabbit Antibody, Charcoal Sep.
Lead, Protoporphyrin Zinc Method, Fluorometric
Radioimmunoassay, Digoxin (125-I), Goat Antibody, Anion Exchange, Resin Sep.
Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.
Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Polyethylene Glycol
Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep.
Radioimmunoassay, Digoxin (3-H), Bovine Antibody, Charcoal Sep.
Radioimmunoassay, Digitoxin (3-H), Rabbit Antibody, Coated Tube
Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep.
Apparatus, General Use, Thin Layer Chromatography
Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Charcoal Sep.
Radioimmunoassay, Digoxin (3-H), Rabbit Antibody, Charcoal Sep.
Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Coated Tube Sep.
Radioimmunoassay, Digoxin (125-I), Bovine Antibody, Charcoal Sep.
Radioimmunoassay, Amphetamine (125-I), Goat Antibody, Ammonium Sulfate Sep.
Radioimmunoassay, Digitoxin (125-I), Bovine Antibody, Charcoal Sep.
Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep.
Dilator, Vessel, For Percutaneous Catheterization
Catheter, Electrode Recording, Or Probe, Electrode Recording
Transmitters And Receivers, Physiological Signal, Radiofrequency
Dc-Defibrillator, High Energy, (Including Paddles)
Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
Amplifier And Signal Conditioner, Transducer Signal
Amplifier And Signal Conditioner, Biopotential
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Cable, Transducer And Electrode, Patient, (Including Connector)
System, Balloon, Intra-Aortic And Control
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Console, Heart-Lung Machine, Cardiopulmonary Bypass
Sucker, Cardiotomy Return, Cardiopulmonary Bypass
Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
Gas Control Unit, Cardiopulmonary Bypass
Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass
Control, Pump Speed, Cardiopulmonary Bypass
Pump, Blood, Cardiopulmonary Bypass, Roller Type
Suction Control, Intracardiac, Cardiopulmonary Bypass
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
Transmitters And Receivers, Electrocardiograph, Telephone
A blood pressure cuff is a device that has an inflatable bladder in an elastic sleeve(cuff) with a mechanism for inflating the bladder.  The cuff is used to determine a subject's blood pressure.
Gauge, Pressure, Coronary, Cardiopulmonary Bypass
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Prosthesis, Vascular Graft, Of Less Then 6mm Diameter
Adhesive, Bracket And Tooth Conditioner, Resin
Sealant, Pit And Fissure, And Conditioner
Resin, Denture, Relining, Repairing, Rebasing
Pin, Retentive And Splinting, And Accessory Instruments
Call for PMAs on 4/21/97 per 62 FR 2902 on 1/27/97
Handpiece, Belt And/Or Gear Driven, Dental
Handpiece, Contra- And Right-Angle Attachment, Dental
Syringe, Restorative And Impression Material
Spreader, Pulp Canal Filling Material, Endodontic
Denture Preformed (Partially Prefabricated Denture)
Unit, Electrosurgical, And Accessories, Dental
Teeth, Artificial, Posterior With Metal Insert
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Polymer, Ent Synthetic-Pife, Silicon Elastomer, Polyethylene, Polyurethane
Adaptor, Short Increment Sensitivity Index (Sisi)
Generator, Electronic Noise (For Audiometric Testing)
Cushion, Earphone (For Audiometric Testing)
Calibrator, Hearing Aid / Earphone And Analysis Systems
Chamber, Acoustic (For Audiometric Testing)
Saw, Surgical, Ent (Electric Or Pneumatic)
Device, Paste-On For Incontinence, Sterile
Device, Incontinence, Urosheath Type, Sterile
Equipment, Photographic, For Physiologic Function Monitor
Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile
System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile
Dilator, Esophageal (Metal Olive) Gastro-Urology
Stimulator, Electrical, Implantable, For Incontinence
Call for PMAs on 7/5/95 per 60 FR 17216 on 4/5/95
To examine and perform procedures within the urinary tract.    For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, av
endoscope, accessories associated with cystoscope
Intrument guided through urethra for visualization and to perform various procedures.
to examine and perform procedures within the sigmoid (descending) colon
endoscope, accessories associated with sigmoidoscope
instrument guided through rectum into the large intestine
Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
Bag, Urine Collection, Leg, For External Use, Sterile
Bougie, Esophageal, And Gastrointestinal, Gastro-Urology
Cord, Electric For Transurethral Surgical Instrument
inserted through endoscope for injection of a solution, gas, or implantable materials into gi or gu tissue.
needle and accessories to needle. does not include pneumoperitoneum needles
instrument guided through endoscope to puncture desired tissue
Cannula And Trocar, Suprapubic, Non-Disposable
to examine and perform procedures within the bile ducts.    For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, avail
endoscope, accessories associated with choledochoscope
instrument guided laparoscopically or through the esophagus into the biliary tree
to endoscopically retrieve magnetic foreign objects
place through endoscope to attract, capture, and remove magnet foreign bodies
magnetic foreign bodies in gi and gu tract
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.fda.gov/cdrh/ode/convkit.html.This type of convenience kit, as listed in the guidance abov
Tray, Biopsy, Without Biopsy Instruments
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
Urinary Drainage Collection Kit, For Indwelling Catheter
Light, Catheter, Fiberoptic, Glass, Ureteral
Insufflator, Automatic Carbon-Dioxide For Endoscope
To provide visualization and perform various procedures within the small intestine.    For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) sub
enteroscope and related accessories, may include balloon, mini-scope
inserted through mouth or laparoscopically
To examine or perform procedures in the colon or rectum    For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, availa
endoscope, accessories associated with colonoscope
To examine or perform procedures in the stomach.    For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at
endoscope, accessories associated with gastroscope
To examine the duodenum and to perform various procedures within the duodenum.    If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 F
endoscope, accessories associated with duodenoscope
To collect cells for cytological evaluation.
Brush goes through endoscope to desired location and rotates to remove and collect cells.
Attachment, Eyepiece, For Insertion Of Prescription Lens
To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation.
Endoscope inserted and advanced through center of device
Tube, Single Lumen, W Mercury Wt Balloon For Intes. Intub. &/Or Decompression
Tube, Double Lumen For Intestinal Decompression And/Or Intubation
Accessories, Photographic, For Endoscope (Exclude Light Sources)
To examine and perform procedures within the anus and rectum.
endoscope, accessories associated with anoscope such as mini-scope
Instrument inserted through anus into rectum
Recorder, External, Pressure, Amplifier & Transducer
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
To allow for visualization of body cavities through an endoscope by projecting images to a monitor.
May include:  ccd camera, monitor, other software or hardware associated with video equiptment, and components from other regulations, such as a pump.
various body cavities, hollow organs, and canals in gi and gu tract.
Device, Urine Flow Rate Measuring, Non-Electrical, Disposable
Collector, Urine, Pediatric, For Indwelling Catheter
Dislodger, Stone, Basket, Ureteral, Metal
Image, Illumination, Fiberoptic, For Endoscope
String And Tubes, Gastrointestinal, To Locate Internal Bleeding
Adaptor, Bulbs, Miscellaneous, For Endoscope
To perform various diagnostic and therapeutic procedures within the urinary tract.    For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) subm
Inserted into blood urinary tract through urethra
Catheter, Retention, Barium Enema With Bag
Stents, Drains And Dilators For The Biliary Ducts
Catheter, Double Lumen Female Urethrographic
Adaptor To The Cord, For Transurethral Surgical Instrument
For establishment of a pneumoperitoneum in abdomen.
May include:  needle, stylet, housing handle.
Instrument inserted into abdomen and gasses or fluids are passed into needle to inflate the abdominal cavity.
Jelly, Lubricating, For Transurethral Surgical Instrument
Jelly, Contact, For Transurethral Surgical Instrument
Chair, Dialysis, Unpowered, Without Scales
Set, Dialysis, Single Needle With Uni-Directional Pump
Pump, Infusion Or Syringe, Extra-Luminal
System, Dialysate Delivery, Recirculating, Single Pass
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Declotting Tray, Kit (Including Contents)
Tray, Start/Stop (Including Contents), Dialysis
Catheter, Peritoneal Dialysis, Single Use
System, Dialysate Delivery, Single Patient
System, Dialysate Delivery, Central Multiple Patient
System, Dialysate Delivery, Sorbent Regenerated
Meter, Conductivity, Induction, Remote Type
Station, Dialysis Control, Negative Pressure Type
Monitor, Electric For Gravity Flow Infusion Systems
Mattress, Air Flotation, Alternating Pressure
Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Stocking, Medical Support (For General Medical Purposes)
Chamber, Reverse Isolation, Patient Care
Prosthesis, Arterial Graft, Bovine Carotid Artery
Catheter, Ureteral, General & Plastic Surgery
Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Esophagoscope, General & Plastic Surgery
Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Gauze/Sponge, Internal, With Drug/Biologic, Animal Source Material
Gauze, External (With Drug/Biologic/Animal Source Material)
Blade, Saw, General & Plastic Surgery, Surgical
Bur, Surgical, General & Plastic Surgery
Mallet, Surgical, General & Plastic Surgery
Fibrinogen Determination Standards And Controls
Standards And Controls, Hemoglobin, Normal And Abnormal
Test, Qualitative And Quantitative Factor Deficiency
Tubes, Vacuum Sample, With Anticoagulant
Reagent & Control, Partial Thromboplastin Time
Cyanomethemoglobin Reagent And Standard Solution
Apparatus, Automated Blood Cell Diluting
Counter, Cell, Automated (Particle Counter)
Separator, Automated, Blood Cell, Diagnostic
Mixture, Control, White-Cell And Red-Cell Indices
Antisera, Latex Agglutination, Cryptococcus Neoformans
Antigen, Latex Agglutination, Coccidioides Immitis
Antiserum, Positive Control, Coccidioides Immitis
Antigen, Cf And/Or Id, Coccidioides Immitis
Antiserum, Positive Control, Histoplasma Capsulatum
Antigen, Latex Agglutination, Entamoeba Histolytica & Rel. Spp.
Antisera, Control For Nontreponemal Tests
Sera, Reactive And Non-Specific Control, Fta-Abs Test
Antisera, Fluorescent Antibody For Fta-Abs Test
Antisera, Fluorescent, All Types, Escherichia Coli
Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.
Antigens, Cf (Including Cf Control), Coxsackievirus A 1-24, B 1-6
Antigen, Fluorescent Antibody Test, Schistosoma Mansoni
Antigens, Cf (Including Cf Control), Echovirus 1-34
Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6
Antisera, Neutralization, Coxsackievirus A 1-24, B 1-6
Antisera, Cf, Coxsackievirus A 1-24, B 1-6
Antigen, Cf (Including Cf Control), Epstein-Barr Virus
Antisera, Neutralization, Influenza Virus A, B, C
Antigens, Ha (Including Ha Control), Influenza Virus A, B, C
Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
Antigens, Ha (Including Ha Control), Adenovirus 1-33
Antigens, Cf (Including Cf Control), Adenovirus 1-33
Antigens, Cf (Including Cf Control), Poliovirus 1-3
Antisera, Hai (Including Hai Control), Rubella
Antigen, Ha (Including Ha Control), Rubella
Antigen, Cf (Including Cf Control), Rubella
Antisera, Fluorescent, All Globulins, Salmonella Spp.
Antisera, Agglutinating, B. Pertussis, All
Antigen, Indirect Fluorescent Antibody Test, Echinococcus Granulosus
Antisera, Positive Control, Echinococcus Spp.
Antigen, Latex Agglutination, Trichinella Spiralis
Antiserum, Bentonite Flocculation, Trichinella Spiralis
Antigen, Bentonite Flocculation, Trichinella Spiralis
Antiserum, Cf, Psittacosis (Chlamydia Group)
Antigen, Cf, Psittacosis (Chlamydia Group)
Antigens, Ha (Including Ha Control), Reovirus 1-3
Antigens, Cf (Including Cf Control), Reovirus 1-3
Antisera, Cf, Equine Encephalitis Virus, Eee, Wee
Antigens, Cf (Including Cf Control), Equine Encephalitis Virus, Eee, Wee
Antisera, Neutralization, All Types, Rhinovirus
Antiserum, Neutralization, Respiratory Syncytial Virus
Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
Antigen, Cf (Including Cf Control), Cytomegalovirus
Antiserum, Cf, Lymphocytic Choriomeningitis Virus
Antigen, Cf, Lymphocytic Choriomeningitis Virus
Antisera, Fluorescent, Herpesvirus Hominis 1,2
Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2
Antisera, Neutralization, Parainfluenza Virus 1-4
Antigens, Ha (Including Ha Control), Parainfluenza Virus 1-4
Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4
Antigen, Cf, (Including Cf Control), Varicella-Zoster
Antigen, Ha (Including Ha Control), Mumps Virus
Antigen, Cf (Including Cf Control), Mumps Virus
Antigen, Ha (Including Ha Control), Rubeola
Antigen, Cf, (Including Cf Control), Rubeola
Antisera, Fluorescent, All Types, Hemophilus Spp.
Antisera, All Fluorescent, Leptospira Spp.
Antisera, Fluorescent, All, Mycoplasma Spp.
Antisera, Fluorescent, All Types, Listeria Monocytogenes
Antisera, All Types, Listeria Monocytogenes
Antigens, Slide And Tube, All Types, Listeria Monocytogenes
Antigens, Slide And Tube, Francisella Tularensis
Antiserum, Positive And Negative Febrile Antigen Control Serum
Antigens (Febrile), Agglutination, Brucella Spp.
Antiserum, Vibrio Cholerae, All Varieties
Antiserum, Flavobacterium Meningosepticum, All Groups
Antisera, Acinetobacter Calcoaceticus, All Varieties
Antisera, Fluorescent, All Globulins, Proteus Spp.
Antigens, Febrile (Weil-Felix), All Groups
Antisera, Fluorescent, All Types, Klebsiella Spp.
Antisera, Fluorescent, All Globulins, Shigella Spp.
Antisera, Bethesda - Ballerup Polyvalent, Citrobacter Spp.
Antiserum, Fluorescent (Direct Test), All Groups, N. Gonorrhoeae
Antisera, Fluorescent, All Groups, N. Meningitidis
Phages, Staphylococcal Typing, All Types
Antisera, Fluorescent, All Types, Staphylococcus Spp.
Antistreptolysin - Titer/Streptolysin O Reagent
Antisera, Fluorescent, All Groups, Streptococcus Spp.
Antigens, All Groups, Streptococcus Spp.
Antisera, All Groups, Streptococcus Spp.
Antisera, Fluorescent, All Types, Streptococcus Pneumoniae
Antisera, All Types, Streptococcus Pneumoniae
Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp
Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations
May include standard electroencephalograph recording hardware (e.g. headbox, cables, computer, monitor, wireless) and basic software (e.g. used to display, store, archive, or manually annotate data).  Does NOT include electrodes, more complex s
Uses electrodes (16 or more) placed on the scalp or within the brain, via user-specified locations, to record and display electrical activity of the brain
Exemption is limited to devices that do not provide an interpretation or a clinical implication of the measurement.
Block, Test, Ultrasonic Scanner Calibration
Call for PMAs to be filed by 3/1/89 per 53 FR 43621 on 12/1/88
Stimulator, Spinal-Cord, Implanted (Pain Relief)
Stimulator, Spinal-Cord, Implanted, For Bladder Evacuation
Call for PMAs to be filed by 12/26/96 per 61 FR 50708 on 9/27/96
Call for pmas to be filed by 7/7/86 per 51 fr 12101 on 4/8/86
Stimulator, Peripheral Nerve, Implanted (Pain Relief)
Stimulator, Nerve, Transcutaneous, For Pain Relief
Device, Galvanic Skin Response Measurement
Drills, Burrs, Trephines & Accessories (Simple, Powered)
Drills, Burrs, Trephines & Accessories (Compound, Powered)
Drills, Burrs, Trephines & Accessories (Manual)
Holder, Head, Neurosurgical (Skull Clamp)
Instrument, Ligature Passing And Knot Tying
Device, Temperature Measurement, Direct Contact, Powered
Table, Obstetrical, Ac-Powered (And Accessories)
Device, Intrauterine, Contraceptive And Introducer
Called for PMAs in FR 5/5/86 PMAs to be filed by 8/4/86
Monitor, Heart-Valve Movement, Fetal, Ultrasonic
Call for PMAs to be filed by 10/3/00 per 65 FR 41332 on 7/5/00
Monitor, Pressure, Arterial, Fetal, Ultrasonic
Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)
Amnioscope, Transabdominal (Fetoscope) (And Accessories)
Coagulator, Laparoscopic, Unipolar (And Accessories)
Monitor, Uterine Contraction, External (For Use In Clinic)
Endoscope, Fetal Blood Sampling (And Accessories)
Monitor, Electroencephalographic, Fetal (And Accessories)
Electrode, Circular (Spiral), Scalp And Applicator
Remover, Intrauterine Device, Contraceptive, Hook-Type
Locator, Intracorporeal Device, Ultrasonic, Obstetric-Gynecologic
Curette, Suction, Endometrial (And Accessories)
Table, Obstetrical, Manual (And Accessories)
Call for PMAs to be filed by 12/26/96 per 61 FR 50709 on 9/27/96
Transcervical Contraceptive Tubal Occlusion Device
Stimulator, Vaginal, Muscle, Powered, For Therapeutic Use
Call for PMAs to be filed by 7/12/2000 per 65 FR 19834 on 4/13/00
Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)
Sampler, Amniotic Fluid (Amniocentesis Tray)
Electrode, Clip, Fetal Scalp (And Applicator)
Brush, Haidinger, (Including Macular Integrity)
Test, Spectacle Dissociation, Ac-Powered (Lancaster)
Refractor, Manual, Non-Powered, Including Phoropter
Instrument, Vitreous Aspiration And Cutting, Battery-Powered
Device, Measuring, Lens Radius, Ophthalmic
Test, Spectacle Dissociation, Battery-Powered (Lancaster)
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
A fixation device is an AC-powered device intended for use as a fixation target for the patient during ophthalmologic examination.  The patient directs his or her gaze so that the visual image of the object falls on the fovea centralis (the cen
Probe And Counter, Isotope, For Phosphorus 32
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Implant, Absorbable, (Scleral Buckling Methods)
Microscope, Operating & Accessories, Ac-Powered, Ophthalmic
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at h
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Rod, Fixation, Intramedullary And Accessories
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Unit, Traction, Hip, Non-Powered, Non-Penetrating
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
Prosthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Ammoniacal Silver Hydroxide Silver Nitrate
Cell Enzymes (Erythrocytic And Leukocytic)
Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Catalase Inhibition
Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Methemoglobin Reduction
Glucose-6-Phosphate Dehydrogenase (Erythrocytic), U.V. Kinetic
Control, Cell Counter, Normal And Abnormal
Apparatus, Suction, Ward Use, Portable, Ac-Powered
Prosthesis, Hip, Femoral Component, Cemented, Metal
Prosthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Mesh, Surgical, Acetabular, Hip, Prosthesis
Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
Device, Fixation, Proximal Femoral, Implant
Instrument, Surgical, Sonic And Accessory/Attachment
Table, Surgical With Orthopedic Accessories, Ac-Powered
Table, Surgical With Orthopedic Accessories, Manual
Analyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling
A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before September 21, 2004, for any indwelling blood oxyhemoglobin concentration analyzer that was in commercial distribution before May 2
Claw, Foreign Body, Bronchoscope (Non-Rigid)
Tubing, Instrumentation, Bronchoscope (Brush Sheath A/O Aspirating)
Acid Phosphatase (Prostatic), Tartrate Inhibited
Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes
Ferric Chloride, Phenylketones (Urinary, Non-Quant.)
Agglutination Method, Human Chorionic Gonadotropin
Differential Rate Kinetic Method, Cpk Or Isoenzymes
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Method, Metallic Reduction, Glucose (Urinary, Non-Quantitative)
Blood, Occult, Enzymatic Method, In Urine
Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
Radio-Labeled Iron Method, Iron (Non-Heme)
Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Analyzer, Chemistry, Micro, For Clinical Use
Analyzer, Chemistry, Centrifugal, For Clinical Use
Apparatus, Electrophoresis, For Clinical Use
Flame Emission Photometer For Clinical Use
Colorimeter, Photometer, Spectrophotometer For Clinical Use
Electrolyte Controls (Assayed And Unassayed)
Controls For Blood-Gases, (Assayed And Unassayed)
Urinalysis Controls (Assayed And Unassayed)
Single (Specified) Analyte Controls (Assayed And Unassayed)
Multi-Analyte Controls, All Kinds (Assayed)
Tubes, Vials, Systems, Serum Separators, Blood Collection
Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
Dinitrophenyl Hydrazone Measurement (Colorimetric), Hydroxybutyric Dehydroge
L-Isocitrate And Nadp (U.V.), Isocitric Dehydrogenase
Hydrazone Deriv. Of Alpha-Ketogluterate (Colorimetry), Isocitric Dehydrogen
Acid, Delta-Aminolevulinic, Ion-Exchange Columns With Colorimetry
Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide
N-Acetyl-L-Tyrosine Ethyl Ester (U.V.), Chymotrypsin
N-Benzoyl-L-Tyrosine Ethyl Ester (U.V.), Chymotrypsin
Atp And Creatine Kinase (Enzymatic), Creatine
Nitroprusside Reaction (Qualitative, Urine), Cystine
Conversion To Ferric Hydroxymates (Colorimetric), Fatty Acids
Tetrahydrofolate, Enzymatic (U.V.), Formiminoglutamic Acid
Uridine-5-Diphosphoglucose, Nad (U.V.), Alpha-D Galactose-1-Phosphate
Sodium Hydroxide And Phenol Red (Titrimetric), Gastric Acidity
Phosphoglycerate Mutase (Colorimetric), 2,3-Diphosphoglyceric Acid
Nadh, Phosphoglycerate Mutase, Atp (U.V.) 2,3-Diphosphoglyceric Acid
Visual, Semi-Quant. (Colorimetric), Glucose-6-Phosphate Dehydrogenase
Nadp Reduction (U.V.), Glucose-6-Phosphate Dehydrogenase
Radioimmunoassay (Two-Site Solid Phase), Ferritin
Fluorescence, Visual Observation (Qual., U.V.), Glutathione Reductase
Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase
Column Chromatography & Color Development, Hydroxyproline
Extraction Plus Chromatography With Color By Ninhydrin, Hydroxyproline
Ferrozine (Colorimetric) Iron Binding Capacity
M. Lysodeikticus Cells (Spectrophotometric), Lysozyme (Muramidase)
Acid, Oxalacetic And Nadh Oxidation (U.V.), Malic Dehydrogenase
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
Citrulline, Arsenate, Nessler (Colorimetry), Ornithine Carbamyl Transferase
Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality
Vapor Pressure, Osmolality Of Serum & Urine
Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine
Column Or Paper Chromatography Plus Ninhydrin, Phenylalanine
Ion-Exchange Resin, Ehrlich'S Reagent, Porphobilinogen
Phosphoenol Pyruvate, Adp, Nadh, Pyruvate Kinase
Beta-D-Fructose & Nadh Oxidation (U.V.), Sorbitol Dehydrogenase
P-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin
N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin
Infrared Spectroscopy Measurement, Urinary Calculi (Stone)
Qualitative Chemical Reactions, Urinary Calculi (Stone)
Stannous Chloride - Hydrazine, Phospholipids
Timed Flow In Capillary, Plasma Viscometry
Glyceralde-3-Phosphate, Nadh (Enzymatic), Triose Phosphate Isomerase
Acid, Trifluoroacetic, Vitamin A, Hexane Extraction
Hexane Extraction, Fluorescence, Vitamin E
Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass
Polymer, Ent Synthetic, Porous Polyethylene
Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Generator, Pulse, Pacemaker, External Programmable
Generator, Pulsatile Flow, Cardiopulmonary Bypass
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before September 21, 2004, for any cardiopulmonary bypass pulsatile flow generator t
System, Multipurpose For In Vitro Coagulation Studies
Antithrombin Iii, Two Stage Clotting Time Assay
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Resin, Ion-Exchange, Thioglycolic Acid, Colorimetry, Iron Binding Capacity
Resin, Ion-Exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity
Radiometric, Fe59, Iron Binding Capacity
Trinitrobenzene Sulfonate (Spectroscopic), Nitrogen (Amino-Nitrogen)
Calculator/Data Processing Module, For Clinical Use
Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica
Station, Pipetting And Diluting, For Clinical Use
Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis)
Culture Media, Multiple Biochemical Test
Culture Media, Non-Selective And Non-Differential
Culture Media, Non-Selective And Differential
Culture Media, Selective And Differential
Culture Media, Selective And Non-Differential
Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Plasma, Coagulase, Human, Horse And Rabbit
Discs, Strips And Reagents, Microorganism Differentiation
Culture Media, For Isolation Of Pathogenic Neisseria
Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained
Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
Antigen, Positive Control, Cryptococcus Neoformans
Antigen, Treponema Pallidum For Fta-Abs Test
Manual Antimicrobial Susceptibility Test Systems
Device, Nerve Conduction Velocity Measurement
Shunt, Central Nervous System And Components
Atomic Absorption Spectrophotometer, General Use
Plates And Equipment, Radial Immunodiffusion
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Prosthesis, Breast, External, Used With Adhesive
Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Set, Administration, For Peritoneal Dialysis, Disposable
Antiserum, Positive Control, Aspergillus Spp.
Antiserum, Positive Control, Blastomyces Dermatitidis
Materials, Repair Or Replacement, Pacemaker
Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Humidifier, Non-Direct Patient Interface (Home-Use)
Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations
A surgeon's glove is a disposable device made of natural rubber latex that may or may not bear powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infe
Ring (Wound Protector), Drape Retention, Internal
Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
Apparatus, High Pressure Liquid Chromatography
Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
Media And Components, Synthetic Cell And Tissue Culture
Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
Nad Reduction (U.V.), Phosphohexose Isomerase
Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
Prosthesis, Knee, Non-Constrained (Metal-Carbon Reinforced Polyethylene) Cemented
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Composite
Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Laparoscopic Contraceptive Tubal Occlusion Device
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Collector, Urine, (And Accessories) For Indwelling Catheter
Surgical Instruments, G-U, Manual (And Accessories)
Call for PMAs on 4/21/97 per 62 FR 2902 on 1/21/97
Adhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-Oxide Homopolymer
Adhesive, Denture, Acacia And Karaya With Sodium Borate
Adhesive, Denture, Polyacrylamide Polymer (Modified Cationic)
Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt
Adhesive, Denture, Carboxymethylcellulose Sodium (40-100&)
Adhesive, Denture, Karaya With Sodium Borate
Adhesive, Denture, Carboxymethylcellulose Sodium And Cationic Polyacrylamide Polymer
Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium
Beads, Hydrophilic, For Wound Exudate Absorption
Media And Components, Mycoplasma Detection
Strip, Temperature, Forehead, Liquid Crystal
System, Dialysate Delivery, Semi-Automatic, Peritoneal
Catheter, Rectal For Continent Ileostomy
Stimulator, Electrical, Non-Implantable, For Incontinence
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Tube, Tympanostomy With Semi-Permeable Membrane
Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase
Table, Cystometric, Non-Electric And Accessories
Device, Vascular, For Promoting Embolization
Analyzer, Pacemaker Generator Function, Indirect
Metal Cemented Constrained Femorotibial Knee Prosthesis
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Metal
Call for PMAs to be filed by 12/26/96 per 61 FR 50710 on 9/27/96
Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
Prosthesis, Knee, Hemi-, Femoral (Uncemented)
Calibrator For Hemoglobin And Hematocrit Measurement
Calibrator For Red-Cell And White-Cell Counting
Kit, Quality Control For Blood Banking Reagents
Media, Potentiating For In Vitro Diagnostic Use
Chamber, Environmental For The Storage Of Platelet Concentrate
Solution, Copper Sulfate For Specific Gravity Determinations
Centrifuge, Cell-Washing, Automated For Immuno-Hematology
Centrifuge, Blood-Bank For In Vitro Diagnostic Use
Container, Empty, For Collection & Processing Of Blood & Blood Components
System, Blood Collection, Vacuum-Assisted, Manual
Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use
System, Test, Automated Blood Grouping And Antibody
Reagent, Immunoassay, Carbonic Anhydrase B And C
Anti-Dna Indirect Immunofluorescent Solid Phase
Complement C3b Activator Immunoassay Reagents
Second Antibody (Species Specific Anti-Animal Gamma Globulin)
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
Prosthesis, Knee, Femorotibial, Non-Constrained, Metal/Composite Cemented
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal
Prosthesis, Finger, Constrained, Metal, Uncemented
call for pmas to be filed by 12/26/96 per 61 FR 50709 on 9/27/96
Prosthesis, Elbow, Hemi-, Radial, Polymer
Prosthesis, Elbow, Hemi-, Humeral, Metal
Appliance, Nail/Blade/Plate Combination, Single Component
Appliance, Fixation, Spinal Intervertebral Body
Prosthesis, Shoulder, Constrained, Metal/Metal Or Metal/Polymer Cemented
Call for PMAs to be filed by 12/26/96 per 61 FR 50711 on 9/27/96
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Radioimmunoassay, Conjugated Sulfalithocholic (Slcg) Acid, Bile Acids
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Prosthesis, Hip, Pelvifemoral Resurfacing,  Metal/Polymer
Pma to be filed by 1/3/05 (69 fr 59134 (10/4/04)) for any hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis that was in commercial distribution before may 28, 1976, or that has, on or before january 3, 2
Adhesive, Denture, Carboxymethylcellulose Sodium (49%) And Ethylene-Oxide Homopolymer
Adhesive, Denture, Karaya And Ethylene-Oxide Homopolymer
Polyvinyl Methylether Maleic Anhydride &/Or Acid Copolymer & Carboxymethylce
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite
Metallic Cemented Glenoid Hemi-Shoulder Prosthesis
Call for pmas to be filed by 12/26/96 per 61 fr 50711 on 9/27/96
Light, Examination, Medical, Battery Powered
Chromatography (Liquid, Gel), Clinical Use
Chromatography (Thin Layer), Clinical Use
Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Gentamicin
Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Kanamycin
Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Tobramycin
High Pressure Liquid Chromatography, Barbiturate
High Pressure Liquid Chromatography, Benzodiazipine
High Pressure Liquid Chromatography, Cocaine And Cocaine Metabolites
High Pressure Liquid Chromatography, Codeine
High Pressure Liquid Chromatography, Methamphetamine
High Pressure Liquid Chromatography, Opiates
High Pressure Liquid Chromatography, Propoxyphene
High Pressure Liquid Chromatography, Quinine
Prosthesis, Finger, Constrained, Metal, Cemented
Device, Neurosurgical Fragmentation And Aspiration
Replacement, Total Ossicular, Prosthesis, Porous, Polyethylene
Replacement, Ossicular (Stapes) Using Absorbable Gelatin Material
Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl
Set, Dialysis, Single Needle (Co-Axial Flow)
Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical
Automated Radioimmunoassay Systems, For Clinical Use
Kit, Test, Pregnancy, Hcg, Over The Counter
Instrumentation, High Pressure Liquid Chromatography
||||Y|N NE|NE|LHG|Electrode, Spinal Epidural|2||N|N||882.5880|1|||||Y|N NE|NE|LIH|Interferential Current Therapy|2||N|N||882.5890|1|||||N|N NE|NE|LLN|Device, Vibration Threshold Measurement|U|1|N|N||882.1200|7||Enforcement discretion applies to
Aids, Speech Training For The Hearing Impaired (Ac-Powered And Patient-Contact)
Aids, Speech Training For The Hearing Impaired (Battery-Operated Or Non-Patient)
U.V. Spectrometry, Tricyclic Antidepressant Drugs
High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs
Acid, Uric, Acid Reduction Of Ferric Ion
Radioreceptor Assay, Human Chorionic Gonadotropin
Enzyme Linked Immunoabsorbent Assay, Rubella
Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing
Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Staphylococcus Aureus Protein A Insoluble
Reagents, Antibody, Legionella, Direct & Indirect Fluorescent
Erythrocyte Suspension, Multi Species, Serological Reagent And Equipment
Device, General Purpose, Microbiology, Diagnostic
Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae
Radioassay, Intrinsic Factor Blocking Antibody
Test, Screening, For D Positive Fetal Rbc'S
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Enzyme Linked Immunoabsorbent Assay, Rotavirus
Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae
CPR Aid device WITH feedback (visual, audio or both) on one or more CPR parameters (e.g., rate, depth, ventilation ratio, etc.), and contains software.  Provides real-time feedback on CPR performance.  Feedback can be audio, visual or both.  De
Enzyme Linked Immunoabsorbent Assay, Rubeola Igg
The qualitative detection of measles specific IgG antibodies in serum or plasma.
antigens and antisera used for the detection of measles antibodies
Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
Electrode, In Vivo Calcium Ion Selective
Detectors And Removers, Lice, (Including Combs)
Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
Port & Catheter, Implanted, Subcutaneous, Intravascular
Enzyme Linked Immunoabsorbent Assay, Mumps Virus
Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.
Culture Media, Antimicrobial Susceptibility Test
Antigens, Indirect Hemagglutination (Iha) Herpes Simplex Virus
Port & Catheter, Implanted, Subcutaneous, Intraventricular
Separator, Automated, Blood Cell And Plasma, Therapeutic
Respiratory Syncytial Virus, Antigen, Antibody, Ifa
Intended to create or maintain sufficient penile rigidity for sexual intercourse.  These include vacuum pumps, constriction rings, and penile splints, which are mechanical, powered or pneumatic devices.
Direct Agglutination Test, Toxoplasma Gondii
System, Blood, Extracorporeal And Accessories
Port & Catheter, Implanted, Subcutaneous, Intraperitoneal
Stimulator, Spinal-Cord, Implanted For Peripheral Vascular Disease
Bed, Therapeutic, Ac-Powered, Adjustable Home-Use
Extractable Antinuclear Antibody, Antigen And Control
Test, Antigen, Nuclear, Epstein-Barr Virus
Laser, Neodymium:Yag For Gynecologic Use
Monitor, Blood-Flow, Cerebral, Thermal Diffusion
Agent, Absorbable Hemostatic, Collagen Based
Agent, Absorbable Hemostatic, Non-Collagen Based
Ceramics, Calcium Triphosphate/Hydroxypatite, Non-Load Bearing Uses
Device, Peritoneal Access, Subcutaneous, Implanted
Laser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolarngology
Monitor, Skin Resistance/Skin Temperature,  For Insulin Reactions
Stimulator, Electrical For Sperm Collection
Agent, Bulking, Injectable For Gastro-Urology Use
Catheter, Percutaneous, Long Term, Intraspinal
Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination
Catheter, Balloon For Retinal Reattachment
Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary
Kit, Test,Alpha-Fetoprotein For Testicular Cancer
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
Hepatitis A Test (Antibody And Igm Antibody)
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Catheters, Transluminal Coronary Angioplasty, Percutaneous
A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end.
This product code pertains to cardiac ablation catheters indicated for general indications, treatment of supraventricular tachycardia (svt) and ventricular tachycardia (vt).  This product code excludes ablation catheters indicated for treatment
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, Cemented
Material, Dressing, Surgical, Polylactic Acid
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Bone Grafting Material, For Dental Bone Repair
Tricalcium phosphate bone grafting material
Gases Used Within Eye To Place Pressure On Detached Retina
Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia
Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
Urinary Homocystine (Nonquantitative) Test System
System, Test, Urinary Methylmalonic Acid
Medical Computers And Software For Ophthalmic Use
Lens, Surgical, Laser, Accesssory, Ophthalmic Laser
Columns, Immunoadsorption In Extracorporeal Systems
Instrument, Prosthesis Modification For Ossicular Replacement Surgery, Sterile
Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
Instrument For Auto Reader Of Overnight Microorganism Identification System
Ph Meter For Dialysis Hydrogen Ion Concentration
Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
Note:  In addition to compliance with our convenience kit guidance, in regards to any drug products contained in this kit compliance with the Center for Drug Evaluation is required as well.  www.fda.gov/cder/index.html - This product code has b
Paste, Injectable For Vocal Cord Augmentation
Implant, Intragastric For Morbid Obesity
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
Calibrator For Alpha-Fetoprotein In Mid-Pregnancy Maternal Serum
Test Reagents, Neisseria Gonorrhoeae Biochemical
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Pulse-Generator, Single Chamber, Sensor Driven, Implantable
Implantable Pulse Generator, Pacemaker (Non-Crt)
These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary.
These devices treat tachycardia (fast heartbeats) with RV defibrillation therapy as necessary.
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Laser, Microsurgical Argon, For Use In Otology
Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Column, Adsorption, Low Density, Lipoprotein
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Polymer/Metal/Polymer
A synthetic bone grafting material is synthetically-derived device, such as hydroxylapatite, intended to fill, augment, or reconstruct periodontal and or bony defects of the upper or lower jaw.
Stimulator, Subcortical, Implanted  For Epilepsy
Stimulator, Autonomic Nerve, Implanted For Epilepsy
Accessories, Solution, Ultrasonic Cleaners For Lenses
Accessories, Fixation, Spinal Intervertebral Body
A latex patient examination glove is a disposable device made of natural rubber latex that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potential
A vinyl patient examination glove is a disposable device made of poly(vinyl chloride) that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand  for medical purposes to provide a barrier against potentia
A  nitrile (or polymer) patient examination glove is a disposable device made of nitrile rubber or synthetic polymers that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to pro
A disposable latex examination glove is a device made of natural rubber latex or synthetic rubber that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand or finger(s) for medical purposes to provide a
Call for PMAs to be filed by 3/30/99 per 63 FR 71746 on 12/30/98 - Indicated for reconstruction of the temporomandibular joint.
The device is a ball and socket joint with one side mounted to the jaw and the other side mounted to the head right in front of the ear.
Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained
Call for PMAs to be filed by 9/12/02 per 67 FR 40849 on 6/14/02
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Prosthesis, Hip, Hemi-, Femoral, Metal Ball
Marker, Cardiopulmonary Bypass (Vein Marker)
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm0
Coronary Stent.  This device is a metal scaffold placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen.
Fastener, Fixation, Biodegradable, Soft Tissue
Catheter, Percutaneous, Intraspinal, Short Term
Kit, Dna Detection, Human Papillomavirus
Cyclosporine And Metabolites Serum Assay
Intervertebral Fusion Device With Bone Graft, Lumbar
Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
hollow cylinder or rectangular box made of metal or polymer
Acts as a disc spacer and holds bone graft.
Prosthesis,  Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish
Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Fastener, Fixation, Nondegradable, Soft Tissue
Fastener, Fixation, Biodegradable, Hard Tissue
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer
Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Sterile
Graft, Vascular, Hemodialysis Access, Synthetic/Biological Composite
Pump, Vacuum, Electric, Suction-Type Electrode
Spinal Pedicle Screw, Fixation, Appliance System
Elastomer, Silicone, For Scar Management
In children with or at risk of developing Thoracic Insufficiency Syndrome, the expandable rib prosthesis devices mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow. The devices are attached perpendic
Instrument, Manual, Surgical, General Use
Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma
The device is a glucose-monitoring device indicated for detecting trends and tracking patterns in adults (age 18 and older) with diabetes. The device is indicated for use as an adjunctive device to complement, not replace, information obtained
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
Stent, Urethral, Prostatic, Permanent Or Semi-Permanent
Stent, Urethral, Bulbous, Permanent Or Semi-Permanent
Device, Removal, Pacemaker Electrode, Percutaneous
Stimulator, Brain, Implanted, For Behavior Modification
Vessel Guard Or Cover, To Facilitate Revision Surgeries
Wrap, patch, or cover intended to protect vessels from injury during surgery, with the secondary function of facilitating revision surgeries by providing a plane of dissection.
Alpha-1 Microglobulin, Antigen, Antiserum, Control
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
High Performance Liquid Chromatography For Cyclosporine
Fluroesence Polorization Immunoassay For Cyclosporine
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Stimulator, Electrical, Implanted, For Parkinsonian Tremor
System, Endovascular Graft, Aortic Aneurysm Treatment
Enzyme Linked Immunosorbent Assay, T. Cruzi
Enzyme Linked Immunosorbent Assay, Coccidioides Immitis
Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum
Catheter, Urological (Antimicrobial) And Accessories
Culture Media, Antimycobacteria, Susceptibility Test
Culture Media, Antifungal, Susceptibility Test
Cpb Check Valve, Retrograde Flow, In-Line
Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented
Stimulator, Functional Walking Neuromuscular, Non-Invasive
This device is a non-wearable prescription use only aed.  These are devices that include automated external defibrillation.  Automated external defibrillators use external pad-type electrodes to sense, detect, classify and treat (with an electr
Nucleic acid assay for detection of Hepatitis B Virus (HBV) DNA is an in vitro nucleic acid assay for detection and quantitation of HBV DNA in human serum or plasma. The assay can be used to measure HBV DNA levels at baseline and during treatme
Enzyme Immunoassasy, Nocotine And Nicotine Metabolites
Dna Probe, Nucleic Acid Amplification, Chlamydia
Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control
Strip, Hama Igg, Elisa, In Vitro Test System
Thin Layer Chroomatography, Tricyclic Antidepressant Drugs
Hemoglobin C (Abnormal Hemoglobin Variant)
Electrocardiograph, Ambulatory, With Analysis Algorithm
Keratoprosthesis, Temporary Implant, Surgical Use
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enf
Blood Establishment Computer Software And Accessories
Resin, Root Canal Filling Containing Chloroform
Adhesive, Denture, Acacia And Karaya With Sodium Borate > 12% By Weight
System, Test, Tumor Marker, Monitoring, Bladder
External Urethral Occluder, Urinary Incontinence-Control, Female
Intended to prevent or decrease episodes of urine leakage in women with stress incontinence.  Occluder is applied to urinary meatus through suction or tape, which creates a barrier for urine leakage.  Occluding device such as a cap, suction cup
Occluding device such as a cap, suction cup, or foam pad. May include adhesive gel or ointment.
Occluder is applied to urinary meatus through suction or tape, which creates a barrier for urine leakage.
Valve, Pressure Relief, Cardiopulmonary Bypass
To prevent patient from biting down in order to protect fragile endoscope equipment, patient's teeth and gums, and endscopist's fingers when inserting endoscope orally.
Accessories, Cleaning Brushes, For Endoscope
Stimulator, Hypoglossal Nerve, Implanted, Apnea
Ventilator, Continuous, Minimal Ventilatory Support,Facility Use
Analyzer, Diagnostic, Fiber Optic (Colon)
Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
Accessory To Continuous Ventilator (Respirator)
Monitor, Heart Rate, Fetal, Non-Stress Test (Home Use)
System, Test, Immunological, Antigen, Tumor
Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free)
Batteries, Rechargeable, For Class 2 Devices
Batteries, Rechargeable, For Class 3 Devices
Call for PMAs 12/26/96 (61 FR 50706 9/27/96))  Patients who are icd indicated and who have atrial tachyarrhythmias, or who are at risk of developing atrial tachyarrhythmias.
Auxillary Power Supply (Ac Or Dc) For Low-Energy Dc-Defibrillator
Auxillary Power Supply (Ac Or Dc) For External Transcutaneous Cardiac Pacemaker
Interarticular Disc Prosthesis (Interpositional Implant)
Semi-Constrained Metal/Polymer Finger Joint Prosthesis
Tissue Adhesive For The Topical Approximation Of Skin
Docket number:  2006p-0071 - may 5, 2008 - reclassified from class 3 pma to class 2 510(k).
Container, Specimen, Urine, Drugs Of Abuse, Over The Counter
Implant, Hearing, Active, Middle Ear, Partially Implanted
Micromanipulators And Microinjectors, Assisted Reproduction
Bilirubin (Total And Unbound) In The Neonate Test System
External Mandibular Fixator And/Or Distractor
Spinal Vertebral Body Replacement Device
System, Hemodialysis, Access Recirculation Monitoring
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
Indicator, Biological, Liquid Chemical Sterilization Process
Products, Contact Lens Care, Rigid Gas Permeable
Enzyme Linked Immunosorbent Assay, Thrombus Precursor Protein
Apparatus, Nitric Oxide, Backup Delivery
Test System, Nicotine, Cotinine, Metabolites
Implanted Subcortical Electrical Stimulator (Motor Disorders)
This system is inteded to be used to drill a small tangential hole in or to thin the zona pellucida of the embryo in selected in vitro fertilization patients with otherwise poor prognois for successful pregnancy outcome, such as advanced matern
Appliances And Accessories, Fixation, Bone, Absorbable Single/Multiple Component
System And Accessories, Isolated Heart, Transport And Preservation
Folders And Injectors, Intraocular Lens (Iol)
System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
Strip, Test, Reagent, Residuals For Dialysate
Total,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer
Test,Prostate Specific Antigen,Free,(Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue
For shrinkage and stabilization of female pelvic tissue for treatment of stress urinary incontinence
A generator supplies radiofrequency energy through a connected applicator with an electrode tip
Kit,Test For Nuclear Matrix(Numa)Protein(For Monitoring And Management Of Colorectal Cancer
Stimulator, Autonomic Nerve, Implanted (Depression)
The device is indicated for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequa
System, Test, Her-2/Neu, Nucleic Acid Or Serum
System, Laser, Fiber Optic, Photodynamic Therapy
Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)
The device is an automatic external defibrillator which monitors and treats a patient for ventricular defibrillation.  Device is intended to be worn in home or in hospital settings as prescribed and overseen by a physician.
Kit, Test, Multiple, Drugs Of Abuse, Over The Counter
System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex
intended to detect Mycobacterium tuberculosis complex nucleic acids extracted from human respiratory specimens. These devices are non-multiplexed and  intended to be used as an aid in the diagnosis of pulmonary tuberculosis when used in conjunc
Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
An optical detection system for the identification of areas on the cervix likely to contain cancer or precancerous cells.
System,Dental,Hydrokinetic,Carries Removal & Cavity Preparation
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
Indicated for use in full-term infants with clinical evidence of moderate to severe hypoxic-ischemic encephalopathy (HIE)*.  Provides selective head cooling with mild systemic hypothermia to prevent or reduce the severity of neurologic injury a
Device, Accessory, Cooling Plate For Tissue Embedding Station
Suture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride)
Immunohistochemistry Antibody Assay, Estrogen Receptor
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg
Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm
Biosensor, Immunoassay, Cpk Or Isoenzymes
System, Blood Collection, Vacuum-Assisted, Automated
System,Detection,Bacterial, For Platelet Transfusion Products
Test, Quantitative, For Hla, Non-Diagnostic
Assay,Enzyme Linked Immunosorbent,Hepatitis C Virus
Assay,Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief
Dressing,Wound,Hydrogel W/Out Drug And/Or Biologic
System,Test,Tumor Marker,For Detection Of Bladder Cancer
Agents,Embolic,For Treatment Of Uterine Fibroids
Stimulator,Peripheral Nerve,Non-Implanted,For Pelvic Floor Dysfunction
The device is a passive mesh wrap that is placed around both ventricles of the heart; The intention is to inhibit further dilatation of the ventricles and thus to facilitate reverse remodeling of the myocardium.  The device is indicated for use
The device is a passive mesh wrap that is placed around both ventricles of the heart; the intention is to inhibit further dilatation of the ventricles and thus to facilitate reverse remodeling of the myocardium.  The device is indicated for use
Lipoprotein, High Density, Hdl, Over The Counter
Autoantibodies,Skin(Desmoglein 1 And Desmoglein 3)
System, Test, Blood Glucose, Over The Counter
Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
Clip, Implantable, For Coronary Artery Bypass Graft (Cabg)
Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
Implant, Cartilage, For Articular Cartilage Repair
Cannula, Arterial, Cardiopulmonary Bypass (Cpb), Embolism Protection
Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered
Lithotripter, Shockwave (For Treating Gallbladder Stones)
Lens, Contact, For Color Vision Deficiency
Rod, Fixation, Intramedullary And Accessories, Metallic And Non-Collapsible
Plate, Fixation, Bone, Non-Spinal, Metallic
Screw, Fixation, Bone, Non-Spinal, Metallic
System, External Fixator (With Metallic Invasive Components)
System, Catheter Or Guidewire, Steerable (Magnetic)
Media, Culture, Ex Vivo, Tissue And Cell
Assay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis
Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis
System, Cryosurgical, Liquid Nitrogen, For Gastroenterology
Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction
System, Ablation, Microwave And Accessories
System, Imaging, Gastrointestinal, Wireless, Capsule
Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
Materials, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Alveolar Ridge Augmentation
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Device, Dental Sonography, For Diagnosis Of Tmj/Mpd Disorders
Device, Dental Sonography, For Monitoring Jaw Sounds
Device, Jaw Tracking, For Diagnosis Of Tmj/Mpd Disorders
Device, Jaw Tracking, For Monitoring Jaw Positions
Test, Cholesterol, Total, Over The Counter
Test, Cocaine And Cocaine Metabolites, Over The Counter
Test, Follicle Stimulating Hormone (Fsh), Over The Counter
Test, Glycosylated Hemoglobin, Over The Counter
Test, Luteinizing Hormone (Lh), Over The Counter
Test, Nitrite, Urinary, Non-Quantitative, Over The Counter
Test, Phencyclidine (Pcp), Over The Counter
The phencyclidine test is an in vitro diagnostic test for the qualitative analysis of phencyclidine in human urine.
Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use.
The trocar/cannula set is a manual surgical instrument intended for use as single-use, disposable cannula system for establishing an entry site conduit for passing ophthalmic instruments used to perform posterior ophthalmic surgical procedures.
The device is an in vitro diagnostic device intended for use in determining quantitative susceptibility of  Candida species to various antifungal agents diluted in varying concentration in a microtiter plate format.
To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.
Polymer, Ear, Nose And Throat, Synthetic, Absorbable
Ear, nose, and throat absorbable synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is shaped and formed by the
Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents)
Used to gain access to the cavities of the brain for injection of material into or removal of material from the brain.
The HS Salivary Cortisol Enzyme Immunoassay Kit is for the quantitative in vitro diagnostic measurement of salivary cortisol.  This kit may be used to measure adrenal cortical function and as a screen for Cushing's and Addison's Disease.  This
Stimulator, Nerve, Electrial, Percutaneous (Pens), For Pain Relief
Percutaneous electrical nerve stimulator (pens) is a device used for the treatment of pain.  Unlike the classified transcutaneous electrical nerve stimulator that apply an electrical current to electrodes on a patient's skin to deliver stimulat
Device, Positive Pressure Breathing, Intermittent
A non self-inflating manual resuscitator, also called a hyperinflation system, is a manual ventilator intended to ventilate a patient by forcing a volume of fresh gas into the patient via compression of the ventilator bag; a source of compresse
Stimulator, Electrical, Implanted, For Parkinsonian Symptoms
Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) using Medtronic Activa Parkinson's Control Therapy is indicated for adjunctive therapy in reducing some of the symptoms of advanced, levodopa-responsiv
This recording sheet is intended to for clinicians to mark the locationof a palpable breast lump identified by a clinical breast examination.
Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)
A desflurane gas analyzer is a device intended to measure the concentration of desflurane anesthetic in a gas mixture.
Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)
A sevoflurane gas analyzer is a device intended to measure the concentration of sevoflurane anesthetic in a gas mixture
Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)
A isoflurane gas analyzer is a device intended to measure the concentration of isoflurane anesthetic in a gas mixture
Assay, Genotype, Hiv Drug Resistance, In Vitro
Assay, Nucleic Acid Amplification, Bacillus Anthracis
An invitro diagnostic device used to presumptively detect the presence or absence of b. Anthracis directly in blood specimens or suspicious culture growth.
System, Water Purification, General Medical Use
The device is a portable water treatment system which features components and technology similar to water treatment systems previously cleared for hemodialysis.  The difference lies with the intended use, as the proposed device is not intended
Electrode, Pacing And Cardioversion, Temporary, Epicardial
The System is indicated for use in postoperative cardiac surgery patients who require temporary atrial or ventricular pacing/sensing and/or atrial cardioversion. Epicardial defibrillation electrodes can be implanted up to 7 days.
Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
The device is used for the detection of anti-cyclic citrullinated peptide (CCP) antibodies in human serum or plasma as an aid in the diagnosis of rheumatoid arthritis.
Assay, Direct, Nucleic Acid Amplification, Respiratory Syncytial Virus
These reagents are nucleic acid primers and probes for the amplification and identification of Respiratory Syncytial virus directly from clinical specimens.  The identification aids in the diagnosis of influenza and provides epidemiological inf
Assay, Direct, Nucleic Acid Amplification, Parainfluenza Virus
These reagents are nucleic acid primers and probes for the amplification and identification of Parainfluenza virus directly from clinical specimens.  The identification aids in the diagnosis of influenza and provides epidemiological information
Assay, Direct, Nucleic Acid Amplification, Influenza Virus
These reagents are nucleic acid primers and probes for the amplification and identification of Influenza virus directly from clinical specimens.  The identification aids in the diagnosis of influenza and provides epidemiological information on
This lens is indicated for daily wear for the correction of refractive ametropia in persons with non-diseased eyes. This lens may also be prescribed as a colored filter to aid individuals who experience reading discomfort not related to binocul
Assay, Proliferation, In Vitro, T Lymphocyte
A device measuring the constituents of dividing DNA or other pre-division cellular constituents to classify the ability of T lymphocytes (a type of normal white blood mononuclear cell) to divide or proliferate in response to specific or non-spe
Catheter, Hemodialysis, Triple Lumen, Non-Implanted
Short-term (< 30 days) central venous access for hemodialysis and apheresis, with a third lumen for infusion.
Catheter, Hemodialysis, Triple Lumen, Implanted
Long-term (> 30 days) central venous access for hemodialysis, and apheresis, with a third lumen for infusion.
System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
An in vitro diagnostic test for the quantitative measurement of the CA 19-9 tumor associated antigen in human serum or plasma.  The test is intended as an aid in the management of patients with confirmed pancreatic cancer and serial monitoring
Disinfectant intended for reprocessing water purification systems for hemodialysis.
Disinfectant intended for reprocessing dialysate delivery systems.
System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species
The in vitro device is intended to detect the presence of the vanA and vanB genes in isolated colonies of Enterococcus spp.  as a marker for vancomycin resistance using DNA probe technology
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
These devices will be indicated for patients needing an ICD who also have moderate to severe heart failure and are indicated for cardiac resynchronization therapy.
Stent, Carotid -- a metal scaffold placed via a delivery catheter into the carotid artery to maintain the lumen
Stent, Renal -- a metal scaffold placed via a delivery catheter into the renal artery to maintain the lumen
Stent, Iliac -- a metal scaffold placed via a delivery catheter into the iliac artery to maintain the lumen
Stent, Superficial Femoral Artery -- a metal scaffold placed via a delivery catheter into the superficial femoral artery artery to maintain the lumen
Stent, coronary, drug-eluting -- a metal scaffold with a drug coating placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen.  The drug coating is intended to inhibit restenosis.
Stent, Superficial Femoral Artery, Drug-Eluting
Stent, Superficial Femoral Artery, Drug-Eluting -- a metal scaffold with a drug coating placed via a delivery catheter into the superficial femoral artery artery to maintain the lumen.  The drug coating is intended to inhibit restenosis.
Stent, coronary, covered -- a metal scaffold covered with material placed via a delivery catheter into the coronary artery artery or saphenous vein graft for the treatment of free perforations and/or to prevent dislodgement into the circulation
Hearing Aid, Air Conduction, Transcutaneous System
The transcutaneous air conduction hearing aid system is a wearable sound-amplifying device that is intended to compensate for impaired hearing.  It consists of an air conduction hearing aid attached to a surgically fitted tube system.  The tube
Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis
ELISA for the detection of anti-SLA (soluble liver antigen) antibody of the IgG class. Intended to aid in the diagnosis of conditions with elevated levels of anti-SLA antibody including autoimmune hepatitis
An iris reconstruction lens is an intraocular lens (IOL) which is used in patients with partial  or complete loss of the iris induced by trauma or congenital defect. The IOL serves as an artificial iris and lens,  reducing light sensitivity and
Accessory, System, External Fixator, Containing Antimicrobial Agent
The device is intended to be used as an accessory surrounding orthopedic pins and wires during external fixation of bones.  The sleeve is impregnated with antibiotic (gentamicin) which is released over time in order to inhibit bacterial coloniz
This is an implantable clip intended to ligate the vas deferens.  This is more specific than the regulation.
Prosthesis, Knee, Femorotibial, Semi-Constrained, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer
Intended to replace part of a knee joint in order to relieve pain and restore knee function, for indications such as uni-compartmental osteoarthritis; inflammatory arthritis; traumatic arthritis; varus, valgus or flexion deformities; and revisi
An intracranial neurovascular stent is a tubular device placed in the blood vessel of the intracranial cavity to treat a vascular abnormality.  It differs from other stents in that it is intended for intracranial use.
The device is used for the semi-quantitative detection of  IgG antibodies to the actin component of smooth muscle in human serum as an aid in the diagnosis of certain autoimmune liver diseases, e.g. autoimmune hepatitis.
Lens, Spectacle (Prescription), For Reading Discomfort
Colored spectacle lenses may also be prescribed as a colored filter to aid individuals who experience reading discomfort not related to binocular vision problems or uncorrected refractive error.
Tonometry for measuring and recording intraocular pressures and intraocular pulse amplitudes, pulsatile ocular blood flow, pulsatile ocular blood volume, pulsatility index equivalent.  Description of why current product c lassificaiton name/pro
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
This type of device is designed to allow for motion between the plastic bearing and metal baseplate components of a knee prosthesis.  It is intended to replace a knee joint in order to relieve pain and restore knee function, for indications suc
An orthodontic ceramic bracket is a device composed of ceramic, which is intended to be bonded to a tooth, upon which an orthodontic wire is used to move the tooth to a new postion.  (the current classification only specifies plastic brackets.
The photochemical treatment system is a class iii medical device for the preparation and storage of pathogen reduced donor derived platelets. The device has the process capability for the pathogen inactivation of platelets having platelet count
System, Mycolic Acid Analysis, Mycobacterium Tuberculosis
A mycolic acids analysis system is intended to aid in the identification of M. tuberculosis and differentiation from other mycobacteria species through the analysis of mycolic acids derived from cultured bacterial samples, using high performanc
Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
A nucleic acid amplification assay system (including probes, other reagents, and instrumentation) is an aid in the identification of group b streptococci from pre-partum and intra-partum women to establish colonization status.
The gloves are intended to protect the operator, patient, or other person from unnecessary exposure to radiation during radiological procedures by providing an attenuating barrier to radiation. Note:  These devices are not patient examination
The Albumin Cobalt Binding Test is a quantitative in vitro diagnostic test used on human serum that detects Ischemia Modified Albumin by measuring the cobalt binding capacity of albumin in human serum. IMA is intended for use in conjunction wit
The device is a vein extractor that is pushed through the leg around the vein to effect saphenous vein harvesting.  It is like a long apple corer, but instead of taking out the apple core you are taking our someone's saphenous vein.
A Breast lesion documentation device is a device for recording and documenting palpable breast lesions detected during a clinical breast exam.
Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.
Tubing/Tubing With Filter, Insufflation, Laparoscopic
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
These devices are indicated for patients who have moderate to severe heart failure. These new devices use an additional lead to provide synchronized pacing of the heart, in addition to the regular features of a pacemaker. These products are sou
Orthosis, Cervical Pedicle Screw Spinal Fixation
This device is a posterior pedicle screw fixation system indicated for any of the following:   Cervical spondylolisthesis (all grades and types) cervical spondylosis   cervical degenerative disc disease   degeneration of the cervical facets acc
uses screws and plates to stabilize spinal segments for fusion
A goniometer is an AC-powered or battery powered  device intended to evaluate joint function by measuring and recording range of motion, acceleration, or forces exerted by a joint. The class II (special controls) goniometer uses transcutaneous
Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter
OTC denture cushion or pad made of wax impregnated cotton cloth that the patient applies to the base or inner surface of a denture before inserting the denture into the mouth. The Device is intended to be discarded following 1 day's use.
Needle, Hypodermic, Single Lumen, Reprocessed
Molecular Adsorbent Recirculating System (Mars)
The molecular adsorbent recirculating system (mars) is an albumin dialysis blood detoxification system designed for the combined removal of water-soluble low molecular weight substances and albumin-bound molecules in the treatment of acute hepa
To repair the mitral valve by coapting the valve leaflets to prevent mitral regurgitation.  These devices are different from the classified device (annuloplasty rings) in that a cardiotomy is not required to place them, some of them are placed
A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger.  At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic si
System, Balloon, Intra-Aortic And Control, Reprocessed
Reprocessed Single Use Device (SUD) requiring 510(k) and previously exempt from submission of validation data.  As of 9/29/05 FR notice validation data is now required.  http://www.fda.gov/cdrh/reprocessing/fr-list2.html
Injector, Contrast Medium, Automatic, Reprocessed
Injector And Syringe, Angiographic, Reprocessed
Injector And Syringe, Angiographic, Balloon Inflation, Reprocessed
Actuator, Syringe, For Injector, Reprocessed
reprocessed needle.  The Phacoemulsification device is NOT reprocessed, just the needle.
Blade for keratome to make flap in cornea for LASIK refractive surgery.  Same as previously cleared blade for keratomes, product codes HMY and HNO, except this is reprocessed.
Used intraocularly to provide light into the posterior of the eye during retinal surgery.  Same as product code MPA, except this one is reprocessed.
Used for cutting soft tissue in or around the eye.  Surgical knife same as product code HNN, except this one is reprocessed.
Trocar, Tracheal, Laryngeal, Sinus, Reprocessed
Same as KBG, KAB, and KCI but need one code for reprocessing
same as DYW except it is being reprocessed
Forceps, Biopsy, Bronchoscope (Non-Rigid), Reprocessed
Laparoscope, General & Plastic Surgery, Reprocessed
Endoscope and accessories, reprocessed is intended to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.  This device is indicated for reuse/reprocessing.
Drills, Burrs, Trephines And Accessories (Simple Powered), Reprocessed
Drills, Burrs, Trephines And Accessories (Manual), Reprocessed
Drills, Burrs, Trephines, And Accessories (Powered Compound), Reprocessed
The ultrasonic scalpel is intended for incision and excision of soft tissues.  This device is indicated for reuse/reprocessing.
Unit, Electrosurgical, Endoscopic (With Or Without Accessories), Reprocessed
This device is intended to be used endoscopically to remove tissue and control bleeding by use of high frequency electrical current.  This device is indicated for reuse/reprocessing.
Intended to obtain samples of tissue by cutting and/or other mechanical means.  This device is indicated for reuse/reprocessing.
Intended to be used endoscopically to snare tissue in preparation for application of electrosurgical current.  This device is indicated for reuse/reprocessing.
forceps, biopsy, electric, reprocessed are intended to be used endoscopically and use electric current to (1) obtain tissue samples for histopathological examination, (2) allow for coagulation so as to prevent bleeding, and (3) destroy the resi
Electrode, Flexible Suction Coagulator, Reprocessed
electorde, flexible suction coagulator, reprocessed is intended to be used endoscopically to provide simultaneous suction of fluids and coagulation of tissue.  This device is indicated for reuse/reprocessing.
Electrode, Electrosurgical, Active, Urological, Reprocessed
electrode, electrosurgical, active, urological, reprocessed is intended to be used endoscopically to contact urologic tissue so as to allow cutting, coagulation, electrodesiccation, or cautery dessication by means of electric current.  This dev
Needle, Pneumoperitoneum, Spring Loaded, Reprocessed
needle, penum.... is intended to insufflate the peritoneal cavity with gas during endoscopic procedures.  This device is indiated for reuse/reprocessing.
Microdebrider, Ent, High Speed, Single Use, Reprocessed
ENT microdebrider is an accessory to an ENT drill system.  It is intended to remove soft and hard tissue during ear, nost and throat surgery.  These devices operate at high speed for precise tissue resection. (this is for reprocessed sing use E
Bur, Ent, Diamond Coated, Single Use, Reprocessed
ENT diamond bur is an accessory to an ENT drill system.  It is intended to remove soft and hard tissue during ear, nose and throat surgery. These devices operate at high speed for precise tissue resection.
Catheter, Oximeter, Fiber Optic, Reprocessed
Reprocessed mask for use with a non-continuous ventilator (CPAP, BiLevel pressure).
Laparoscope And Accessories, Gynecologic, Reprocessed
A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital
Laparoscopic Insufflator And Accessories, Reprocessed
implantable clip, reprocessed is intended to connect internal tissues to aid in healing.  It is not absorbable.  This device is indicated for reuse/reprocessing.
Catheter, Angioplasty, Peripheral, Transluminal, Reprocessed
Needle And Needle Set, Gastro-Urology, Reprocessed
Needle, Aspiration And Needle, Reprocessed
Set, Dialysis, Single Needle With Uni-Directional Pump, Reprocessed
Prosthesis modification instrument for ossicular replacement surgery; see product code JXT.
Prosthesis modification instrument for ossicular replacement surgery; see product code JXY.
Prosthesis modification instrument for ossicular replacement surgery; see product code JXW.
Prosthesis modification instrument for ossicular replacement surgery; see product code JXX.
Prosthesis modification instrument for ossicular replacement surgery; see product code JXS.
Instrument, Prosthesis Modification For Ossicular Replacement Surgery, Non-Sterile
Prosthesis modification instrument for ossicular replacement surgery; see product code LRE.
Prosthesis modification instrument for ossicular replacement surgery; see product code JXZ
Scissors, Wire Cutting, Ent, Non-Sterile
Prosthesis modification instrument for ossicular replacement surgery; see product code JYA.
Prosthesis modification instrument for ossicular replacement surgery; see product code JYB.
Bag, Urine Collection, Leg, For External Use, Non-Sterile
Urine collector and accessories; see product code FAQ.
Device, Incontinence, Urosheath Type, Non-Sterile
Urine collector and accessories; see product code EXJ
Sheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile
Urine collector and accessories; see product code EYT.
System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile
Urine collector and accessories; see product code EYZ.
Device, Paste-On For Incontinence, Non-Sterile
Urine collector and accessories; see product code EXI.
Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile
Splint, Extremity, Non-Inflatable, External, Non-Sterile
Non-inflatable extremity splint; See product code fyh.
Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2
The Lipoprotein-associated Phospholipase A2, Immunoassay, System, Test, is intended to measure lipoprotein-associated phospholipase A2 in human plasma in conjunction with clinical evaluation and other patient risk factors including biochemical
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
An optical impression system for cad/cam of dental restorations is a device used to record the topographical characteristics of teeth, dental impressions, or stone models by analog or digital methods for use in the computer aided design and man
Stand, Instrument, Ophthalmic, Battery Powered
AC-powered or non-powered device intended to store ophthalmic instruments in a readily accessible position.
Prosthesis, Breast, External, No Adhesive
Material, External Aesthetic Restoration, No Adhesive
The Platelia Aspergillus EIA is an immunoenzymatic sandwich microplate assay for the detection of Aspergillus galactomannan antigen in human serum.    It is a test which, when used in conjunction with other diagnostic procedures such as microbi
same as procode FCL except this product is for the reprocessed device.
The device is a clamp used to close off needle holes in the arm of a Dialysis patient.  The clamp applies uniform pressure to the sites of needle holes in the patient's arm until the holes close.  The clamp pressure is designed to stop bleeding
The West Nile Virus ELISA is intended for the detection of IgG and IgM antibodies to West Nile Virus. Specimens may be serum or cerebral spinal fluid from symptomatic patients.
This product code was needed for the home use indication.  CBK is not a tracked device and NOU is a tracked device.
This device is indicated for attaching suture into bone for suspension of the nasal valve and for attaching suture into bone at the lower orbital rim.
The device acts as a bone void filler and consists of a filling material and a synthetic peptide.  It is intended to fill traumatic or surgically-created defects that are not intrinsic to the bony structure of the extremities, spine or pelvis.
Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia
The device comprises one or more objects placed in a blood vessel to permanently obstruct blood flow to the prostate to treat benign prostatic hyperplasia (BPH).
A catheter is threaded from femoral artery to the prostatic artery and beads are injected until stasis in flow is achieved.
The test provides quantitative measurement of 1,5-anhydroglucitol (15AG) in patient's blood. The test is for professional use, and is indicated for the monitoring of glycemic control in people with diabetes.
System, Monitoring, For Progress Of Labor
This monitoring system for progress of labor provides intrapartum measurement of cervical dilation, fetal head station, and/or other sentinel anatomical markers.  This device is intended to be used adjunctively with other diagnostic information
Material, Embolization, Neurovascular, Polymerizing Or Precipitating
This is an neurovascular embolization device which is placed in a blood vessel to permanently obstruct blood flow to an aneurysm or other vascular malformation.  It is unlike the coil or particulate embolization devices in that it polymerizes o
Same as the identification for product code FLS, just add home use
Antigen, Cartilage Oligomeric Matrix Protein (Comp)
COMP ELISA is a quantitative enzyme-linked immunosorbent assay for detecting COMP (Cartilage Oligomeric Matrix Protein) in patient sera. The presence of elevated levels, when considered in conjunction with other laboratory and clinical findings
Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
The device is intended to replace the medial condyle and the patellofemoral compartment of the distal femur with a single device.  The device is meant to be used with a uni-compartmental tibial base and insert and a resurfacing patella.  The de
A synthetic dental barrier is a synthetic material device, such as ptfe, intended to aid in guided tissue and/or bone regeneration procedures and to act as a stable barrier for the containment of bone graft materials.
An animal source dental barrier is an animal-derived material device, such as collagen, intended to aid in guided tissue/bone regeneration procedures and to act as a stable barrier for the containment of bone graft materials when placed around
A animal-source bone grafting material is a naturally-derived device, such as collagen, intended to fill, augment, or reconstruct periodontal defects and or bony defects of the upper or lower jaw.
Kit, Immunochromatographic, Bacillus Anthracis Differential Antibody
A serological reagent to distinguish b. Anthracis culture growth  from other bacillus spp. Growth
The intended use for the reprocessed/reused blood pressure cuff is use in manual measurement and automatic non-invasive blood pressure monitoring by properly trained personnel.  Complete inflation systems are designed for use with manometers du
Test, Factor V Leiden Mutations, Genomic Dna Pcr
In vitro diagnostic test to detect the Factor V Leiden mutation in genomic DNA, as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.
Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
In vitro diagnostic test to detect the Factor II G20210A mutation in genomic DNA, as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.
Aortic Valve, Prosthesis, Percutaneously Delivered
To replace a patient's aortic heart valve.  They are different from the classified device (heart valves) in that they are placed percutaneously and do not require open chest surgery or a cardiotomy for placement.
Prosthesis, Mitral Valve, Percutaneously Delivered
These devices are intended to replace a patient's mitral heart valve.  They are different from the classified device (heart valves) in that they are placed percutaniously and do not require open chest surgery or a cardiotomy for placement.
Pulmonary Valve Prosthesis Percutaneously Delivered
These devices are intended to replace a patient's pulmonary heart valve.  They are different from the classified device (heart valves) in that they are placed percutaneously and do not require open chest surgery or a cardiotomy for placement.
Bone Grafting Material, Dental, With Biologic Component
Dental bone grafting material with growth factors is a combination product which consists of a bone grafting material which contains biologic or drug components, such as proteins, that are intended to stimulate and/or inhibit the growth of cert
Other dental material with growth factors is a material, used with or without other devices, which contains biologic or drug components, such as proteins, that are intended to stimulate and/or inhibit the growth of certain tissues of the oral a
The ophthalmic conformer with molded plastic and biological tissue insert is introduced temporarily between the eyeball and eyelid to maintain space in the orbital cavity, prevent closure or adhesions during the healing process following surger
Test, Breath Analysis, Volatile Organic Compounds
Breath analysis test for use as an aid in the diagnosis of grade 3 heart transplant rejection in first year heart recipient patients
Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
In vitro diagnostic test to measure C-reactive protein for the purpose of making cardiac risk assessments.
Specular microscopes are used for the microscopic imaging and assessment of the corneal endothelial cell layer in vivo or in vitro.
The device is used to stabilize, move, lift, and position the heart during cardiovascular surgery.
This device is intended to measure the pressure in the aneurysm sac during and after an endovascular procedure.
Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use
Dual lumen, non-implanted, peripheral access catheters are inserted in the peripheral arm vein and are indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload.
Phaenicia sericacta (blow fly) larvae are harvested and provided disinfected for use in debriding non-healing necrotic skin and soft tissue wounds, including pressure ulcers, venous stasis ulcers, neuropathic foot ulcers, and non-healing trauma
System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry
Amino acids, free carnitines and acylcarnitines test system is intended for the measurement and evaluation of amino acid, free carnitine and acylcarnitine concentrations from newborn whole blood filter paper samples. The quantitative analysis o
Immunoassay For Detection Of Amniotic Fluid Protein(S).
The test is for use by health care professionals to aid in the detection of fetal membrane rupture in pregnant women, when they report signs, symptoms or complaints suggestive of such rupture.
: for testing cervicovaginal fluid specimens
This device is an interspinous spacer or spinous process plate that is implanted between the spinous processes or attached to the spinous process.
Posterior Metal/Polymer Spinal System, Fusion
This device is a posterior spinal system that contains polymer and metal components.  This spinal system is to be used with bone graft and is an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoraci
Dural sealants are devices intended to aid in preventing cerebrospinal fluid leakage through suture-approximated dural wound edges.  The sealant is sprayed or layered onto sutured dural wound edges and allowed to polymerize in place.
Intended for use in orthodontic treatment.  The device is affixed to a tooth so that pressure can be exerted on the teeth.
Dislodger, Stone, Flexible, Ureteral, Reprocessed
A ureteral stone dislodger is a device that consists of a bougie or a catheter with a special flexible tip.  It is inserted through a cystoscope and used to entrap and remove stones from the ureter.
Dislodger, Stone, Basket, Ureteral, Metal, Reprocessed
A ureteral stone dislodger is a device that consists of a bougie or a catheter with an expandable wire basket near the tip.  It is inserted through a cystoscope and used to entrap and remove stones from the ureter.
A tracheobronchial suction catheter is a device used to aspirate liquids or semisolids from a patient's upper airway.
Orthosis, Spine, Plate, Laminoplasty, Metal
This device is a plate that is attached to the lamina after a laminoplasty or laminectomy procedure.
System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
A nucleic acid amplification assay system (including probes, other reagents, and instrumentation) is an aid in the identification of MRSA colonization status for the prevention and control of MRSA infections in healthcare settings.
Ventilator, Continuous, Minimal Ventilatory Support, Home Use
This continuous ventilator, which operates using a fixed or passive exhaust port, is intended to treat patients with respiratory failure in the home.
Invasive fungal pathogen assays are devices that consist of antigens, antisera, or proteases used in serological assays for the presumptive diagnosis of fungal infection in serum or plasma.  The assay is indicated for use in patients with sympt
Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing
This type of device is designed to allow for motion between the plastic tibial bearing and metal tibial baseplate components of a unicompartmental knee prosthesis.  It is intended to replace part of a knee joint in order to relieve pain and res
The ultrasound wound cleaner/mild debridement system is a device that delivers a cleaning fluid to the wound that is pulsed using low power ultrasound radiation.  The device is intended to clean and mildly debride wounds.  The ultrasound genera
A scented or scented deodorized pad is a device made of common cellulosic or synthetic material with an established safety profile.  This does not include menstrual pads treated with added antimicrobial agents.  These are used to absorb menstru
Air compressor and vacuum unit that are connected to dental operative unit to provide compressed air and vacuum capability to power and drive other dental devices, which are attached to the dental operative unit.
Material, Quality Control, Semen Analysis
A semen analysis quality control material is a device used to determine the accuracy and precision of manual, semiautomated, and automated determinations of semen analysis parameters such as pH, sperm concentration, total sperm number, motility
Breath measurement systems are used to measure constituents of exhaled breath as an aid in the diagnosis of sugar/nutrient malabsorbtion and other conditions.
Autoantibodies, Nuclear Pore Glycoprotein Gp210
The device is used for the detection, in human serum or plasma, of autoantibodies to gp210 (nuclear pore glycoprotein gp210) as an aid in the diagnosis of primary biliary cirrhosis.
Indicated for the temporary disruption of the outer layer of skin for the application of drugs, etc.
The home test for loss of the sense of smell is packaged in a small carton which contains (1) an instruction book, (2) a booklet containing twelve micorencapsulated smell strips, each on a separate page, with instructions for scoring the test a
Enzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis
The elisa assay for antibodies to b. Anthracis is used to detect an immunological response to proteins secreted by b. Anthracis; As an aid in the laboratory diagnosis of anthrax.
an adjunct to the graft tissue healing when problems of venous congestion may delay healing, or to overcome the problem of venous congestion by creating prolonged localized bleeding.
Sirolimus test systems are intended for the quantitative measurement of sirolimus in whole blood as an aid in management of transplant patients taking this sirolimus.
Device made of a material such as titanium or titanium alloy, that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patie
Control Material, Blood Circulating Epithelial Cancer Cell
The Epithelial Cell Control Kit contains two levels of fixed cells that are stained with a fluorescence marker and are used to verify sample processing and cell analysis of circulating tumor cells.  This device is used as an assay quality contr
A dental chair is a device, usually powered, that is intended to seat a patient in the proper position to perform a dental procedure.
Implantable Radio Frequency Transponder System
An implantable microtransponder system intended to facilitate access to identification and health information in humans.  It is described as consisting of a small implantable electronic microtransponder, an insertion device (introducer), and an
The Automatic Intramuscular Stimulator is a device that aids muscle stimulation by using a method called dry needling for treatment.  The device consists of a main control unit, a hand-held motor unit, and an AC power supply adapter.  The motor
Complement 4d (C4d) And Complement Receptor 1 (Cr1)
The device is an indirect immunofluorescence assay utilizing monoclonal antibodies and flow cytometry in the quantitative determination of complement 4d (C4d) and complement receptor 1 (CR1) on the surface of erythrocytes from EDTA anti-coagula
The device is intended to restore blood flow by removing thrombus/clots in patients experiencing ischemic stroke.  The prior clearances in this category have been limited to simply identifying catheter placed in the peripheral, coronary, and ne
Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided
An mr-guided focused ultrasound system is intended to use hifu to ablate soft tissue.  Mr imaging and thermal mapping are used to plan and monitor the use of ultrasound ablation before and during the procedure.
Automated external defibrillators are devices that use external pad-type electrodes to sense, detect, classify and treat (with an electrical shock) ventricular fibrillation.  These devices are intended to be used on suspected victims of sudden
This device contains items given to an individual during their hospital stay.
A pen injector is a device that provides a nonelectrically-powered, mechanically-operated method of accurately injecting a dose of medicinal product from a medicinal cartridge, reservoir, or syringe through a manually-inserted single lumen hypo
Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence
In vitro diagnostic test to detect aneuploidy for chromosomes 3, 7, 17 and loss of the 9p21 locus via fluorescence in situ hybridization (fish) in urine specimens from persons suspected of having bladder cancer.  It is an adjunctive test for in
Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment
In vitro diagnostic test intended as a risk assessment test for the development of hepatocellular carcinoma (hcc) in patients with chronic liver diseases (cld).  Elevated afpl3% values (= 10%) have been shown to be associated with a nine-fold i
System, Imaging, Esophageal, Wireless, Capsule
THE CAPSULE IS A DISPOSABLE, INGESTIBLE CAPSULE DESIGNED TO ACQUIRE VIDEO IMAGES OF THE ESOPHAGUS.  THE CAPSULE TRANSMITS THE ACQUIRED IMAGES VIA RF COMMUNICATION CHANNEL TO A DATA RECORDER LOCATED OUTSIDE THE BODY.  THE DIAGNOSTIC IMAGING SYST
Foreign dental lab manufactured noble metal restorations are crowns, bridges, inlays, and onlays that are manufactured as finished products from noble metals.
Foreign dental lab manufactured partial dentures are manufactured as finished products from denture resins and other supporting materials.
Foreign dental lab manufactured full dentures are manufactured as finished products from denture resins.
Foreign dental lab manufactured resin restorations are permanent restorations that are manufactured as finished products from resins.
Foreign dental lab manufactured resin crown and bridge restorations are crown and bridge restorations that are manufactured as finished products from resins.
Foreign dental lab manufactured porecelain-fused-to-metal restorations are porcelain-fused-to-metal crown and bridge restorations that are manufactured as finished products from porcelain and noble or base metal alloys.
Foreign dental lab manufactured porcelain restorations are full porcelain crown and bridge restorations that are manufactured as finished products from porcelains.
Foreign dental lab manufactured base metal restorations are crowns, bridges, inlays, and onlays that are manufactured as finished products from base metals.
Foreign dental lab manufactured orthodontic prosthesis are finished custom-fit orthodontic prosthesis.
Treatment of nausea and vomiting associated with morning sickness and motion sickness.
Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking
THE DEVICE IS AN IMMUNOASSAY INDICATED AS AN AID IN THE DIAGNOSIS OF MYASTHENIA GRAVIS, AN AUTOIMMUNE DISEASE CHARACTERIZED BY EXERCISE-INDUCED MUSCLE WEAKNESS TEMPORARILY RELIEVED BY CESSATION OF EXERCISE. AUTOANTIBODY, WHEN PRESENT IN SERUM,
Instrumentation For Clinical Multiplex Test Systems
Instrumentation for clinical multiplex test systems is a device that is intended to measure and sort multiple signals generated by an assay from a clinical sample.  The generated signals from multiple probes or other ligands may be measured by
Software, Transmission And Storage, Patient Data
Non-alarming software that captures patient data from patient monitoring devices and transmits the data to the patient electronic medical record, where the data is stored.
System, Ablation, Ultrasound And Accessories
Intended for use as a surgical tool for coagulation and ablation of soft tissue. This differs from the description in the regulation in that this device is not intended to cut tissue and this device uses high intensity ultrasound energy instead
Temporary Carotid Catheter For Embolic Capture
This device is a single use percutaneous catheter system that is introduced into an artery through the skin using a guidewire.  The catheter has an embolic capture filter or an occlusion balloon at the distal end.  The filter or balloon can be
An ankle joint metal/polymer non-constrained uncemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no
System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays
Drug Metabolizing Enzyme Genotyping Systems
Intended to identify the presence or absence of human genotypic markers encoding drug metaboizing enzymes using dna originating from clinical samples. This type of assay can be used as an aid determining treatment choice and individualizing tre
Caries Detector, Laser Light, Transmission
Antigen, Inflammatory Response Marker, Sepsis
An immunoluminometric assay used to determine the concentration of procalcitonin (pct) in human serum and plasma.
Used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals
Rinse, Oral, Antibacterial (By Physical Means)
Antibacterial oral rinse that is used as an aid in the treatment of gingivitis, acting by physical rather than chemical means. The rinse works by coating tooth and tissue surfaces, providing a positive charge that reduces bacterial adhesion.
Intended to evaluate the functionality of human pain reception and transmission of sensory pathways
MYELOPEROXIDASE, IMMUNOASSAY, SYSTEM, TEST IS INTENDED TO MEASURE MYELOPEROXIDASE IN HUMAN PLASMA, TO BE USED IN CONJUNCTION WITH CLINICAL HISTORY, ECG AND CARDIAC BIOMARKERS TO EVALUATE PATIENTS PRESENTING WITH CHEST PAIN THAT ARE AT RISK FOR
System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test
System for collection, storage, and transport of whole blood and stabilization of intracellular rna with subsequent isolation and purification of host rna for rt-pcr used in molecular diagnostic testing
Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68)
A NURSING PAD CONSISTING OF A POLYURETHANE PAD WITH GLYCERIN USED TO RELIEVE NIPPLES THAT ARE SORE AND CRACKED FROM BREASTFEEDING.
System, Test, Fibrin/Fibrinogen Degradation Products For Monitoring Of Colorectal Cancer
MONITORING CANCER PATIENTS AFTER THERAPY FOR DISEASE PROGRESSION IN CONJUNCTION WITH OTHER DIAGNOSTIC MODALITIES.
Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator
DEVICE PROVIDES SEMIQUANTITATIVE INDICATIONS OF PH, BICARBONATE IONS, AND GLUCOSE IN THE FINAL BICARBONATE DIALYSATE.
System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
The cftr gene mutation detection system is a device used to simultaneously detect and identify a panel of mutations and variants in the cftr gene.  It is intended as an aid in confirmatory diagnostic testing of individuals with suspected cystic
Multiplex qualitative amplification based detection system.  Should not include devices which use sequencing based detection methods.
Uses multiplex polymerase chain reaction to amplify specific DNA variants located on the CFTR gene using non-sequencing based methods.
Human peripheral whole blood or clinical samples.
Colonic Irrigation System, General Well Being
Call for PMAs on 12/26/96 per 61 FR 50707 on 9/27/96 - Colon cleansing for routine general well being
This device is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication.  This product may or m
THIS DEVICE IS INDICATED FOR THE FIXATION OF PATHOLOGICAL FRACTURES OF THE VERTEBRAL BODY USING VERTEBROPLASTY OR KYPHOPLASTY PROCEDURES.   THE DEVICE RESORBS (TIME FRAME MAY BE INDICATED) AND IS REPLACED WITH BONE DURING THE HEALING PROCESS.
Call for PMAs - 12/26/96 per 61 FR 50708 on 9/27/96 - For the treatment of cerebral ischemia resulting from symptomatic  vasospasm following aneurismal subarachnoid hemorrhage, secured by either  surgical or endovascular intervention for patien
TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES
FOR REGIONAL INFUSION OF CONTRAST MATERIALS INTO SELECTED VESSELS IN THE NEURO-VASCULATURE.  THE DEVICE MAY BE USED FOR CONTROLLED, REGIONAL INFUSION INTO SELECTED VESSELS AND IS NOT INTENDED FOR USE IN THE CORONARY VASCULATURE.
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
For Export Only - Antigen, Anti-Cardiac, Indirect Fluorescent Antibody Test System
For Export Only - Antigen, Anti-Skeletal, Indirect Fluorescent Antibody Test System
Autoantibodies, Nuclear Body Protein, Sp100
THE DEVICE IS USED FOR THE DETECTION, IN HUMAN SERUM OR PLASMA, OF AUTOANTIBODIES TO SP100 (NUCLEAR BODY PROTEIN SP100) AS AN AID IN THE DIAGNOSIS OF PRIMARY BILIARY CIRRHOSIS.
INTENDED TO BE PACKED INTO BONY VOIDS OR GAPS TO FILL AND/OR AUGMENT DENTAL INTRAOSSEOUS, ORAL AND CRANIO-/MAXILLOFACIAL DEFECTS.  THESE DEFECTS MAY BE SURGICALLY CREATD OSSEOUS DEFECTS OR OSSEOUS DEFECTS CREATED FROM TRAUMATIC INJRY TO THE BON
Cream, Nasal, Topical, Mechanical Allergen Particle Barrier
THE DEVICE IS INTENDED TO PROMOTE ALLEVIATION OF MILD ALLERGIC SYMPTOMS TRIGGERED BY THE INHALATION OF VARIOUS ALLERGENS.
A reusable menstrual pad is made of cellulosic or synthetic material used to   absorb menstrual fluid or other vaginal discharge.
A interlabial pad made of cellulosic or synthetic material which is placed over the vaginal introitus to absorb menstrual fluid or other vaginal discharge.
Temporary reduction of myopia or refractive error.
THE DEVICE IS INTENDED TO TEMPORARILY ALTER THE APPEARANCE OF CELLULITE
Relief of muscle spasms associated with tmj.  Muscle reeducation, increasing blood flow.
Effervescent tablet for the removal of micro-organisms from removable dentures and retainers.
Cancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Mesothelioma
Manual or ac powered device intended to measure intraocular pressure. Intended for use in the diagnosis of glaucoma.
BONE HETEROGRAFT IS A DEVICE INTENDED TO BE IMPLANTED THAT IS MADE FROM MATURE (ADULT) BOVINE BONES AND USED TO REPLACE HUMAN BONE FOLLOWING SURGERY IN THE CERVICAL REGION OF THE SPINAL COLUMN.
This automated device is intended to be used to clean endoscopes.  Endoscopes that are intended to be cleaned by the automated cleaner system should have been pre-cleaned and tested for leaks and lumen obstructions according to the instrument m
Intended to temporarilty nourish cells on an avulsed tooth
In approximation and/or ligation of soft tissue
Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease
The device is intended to suggest a systemic autoimmune disease association as an aid for differential diagnosis to be evaluated in conjunction with clinical findings and other laboratory tests.
Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women
Delivery of radio frequency energy to the submucosal tissue of the bladder neck and proximal urethra for the transurethral treatment of female stress urinary incontinence due to hypermobility.
Consists of radio frequency probe and generator and accessories.
Intended for the incision,  excision, cutting, ablation, and vaporization of soft tissue in oral and maxillofacial surgery and  dentistry.
Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon
Percutaneous transluminal angioplasty of peripheral vasculature exclusive of coronary arteries
Comprised of a catheter body with two concentric distal inflatable balloons.
Used independently for dilation or dilatation of diseased peripheral vasculature to restore blood flow
Peripheral vasculature exclusive of coronary arteries.
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
Drug eluting permanent RV or RA pacemaker electrodes are used with compatible  pacemakers or implantable cardioverter defibrillators (ICD) or cardiac rhythm therapy (CRT) devices to deliver pacing pulses to the heart.
The device is a flexible, insulated electrical conductor with one end designed to make a secure connection to a pacemaker or ICD or CRT and the other end applied to the myocardium.
Used as part of an implantable pacemaker system.
Makes contact with the heart (myocardial tissue).
Spacers are devices that are used with nebulizers and metered dose inhalers that are comprised of a reservior into which an aerosol medication is dispensed.  A spacer uses an open mouthpiece.  Spacers are intended to minimize delivery of large
Spacers are frequently made of plastic, and can be tube shapped.
By holding drugs after aerosolization, spacers are intended to minimize delivery of large aerosolized particles, which would otherwise deposit in the mouth.
Spacers contact the mouth.  The drug they are holding is intended for the lower airways
Holding Chambers, Direct Patient Interface
Holding chambers are devices that are used with nebulizers and metered dose inhalers and are comprised of a reservoir into which an aerosol medication is dispensed. A holding chamber uses a valved mouthpiece through which the patient inhales th
Holding Chambers are frequently made of plastic, and can be tube shaped.
By holding drugs after aerosolization, holding chambers are intended to minimize delivery of large aerosolized particles which would otherwise depisit in the mouth, throat, or upper airway
Holding Chambers contact the mouth.  The drug they are holding is intended for the lower airways
Bacteriophage And Controls, B. Anthracis Lysis
A gamma phage lysis assay intended for the identification of bacillus anthracis from non-hemolytic, aerobic gram positive colonies isolated from sheep blood agar.  To aid in the laboratory identification of bacillus anthracis culture growth by
Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar
Intended to be inserted between the vertebral bodies into the disc space from l3 to s1 to provide stabilization and to help promote intervertebral body fusion.  To be used with bone graft, for holding bone parts in alignment while they heal.  N
Inserted between the vertebral bodies in the disc space.
Intervertebral disc space from L3 to S1.
Tubing and tubing/filter fits are used when there is a need to distend the uterus by filling the uterine cavity with a liquid or gas to facilitate viewing with a hysteroscope.
tubing and tubing/filter fits which only include accessory instruments that are not used to effect intrauterine access, e.g., hysteroscopic introducer sheaths, etc.; and single-use tubing kits used for only intrauterine insufflation.
tubing and tubing/filter fits which only include accessory instruments that are not used to effect intrauterine access
Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System
Intended for clinical laboratory image storage and communications.  A clinical laboratory image storage and communications device is a device that provides electronic storage and retrieval functions, and provides electronic transfer for non-dia
The clinical laboratory image storage and communications device is composed of the necessary hardware and software for digital image capture and storage.
Allows users to receive and store documents and non-diagnostic clinical laboratory digital images in a central repository or Laboratory Information System (LIS).  It will allow users to scan any document for storage or retrieval and may incorpo
Permanent defibrillator electrodes are used with compatible implantable cardioverter defibrillators (ICD) and cardiac rhythm therapy-defibrillators (CRT-D) to sense the cardiac rhythm and to deliver high energy therapy to the heart when tachyca
The device is a flexible, insulated electrical conductor with one end designed to make a secure connection to an ICD or CRT-D and the other end located in a position which directs defibrillation energy to the heart
Used as part of an implantable defibrillation system.
Makes contact with the heart (endocardial or myocardial tissue) or is located in a proximity and orientation that creates a vector for defibrillation energy to the heart.
Intended as a permanent implant to deliver pacing pulses and other pacing therapies through pacing leads implanted in the heart.
A hermetically sealed outer can (usually metallic) houses electronic circuitry and allows for connection to pacing leads (electrodes).
Used as part of a pacing system that consists of a pulse generator and a lead, and which may also require an external pacemaker programmer.
Implanted in the chest or abdomen, and makes contact with cardiac tissue via pacing leads.
The device is intended to provide support to weakened or constricting airway walls.
The device is tubular and traditionally made of silicone. Devices can range roughly from 6-14mm in diameter and have lengths as small as 20 mm to lengths as long as 150mm.
The device functions independently providing physical support to the constricting airway.
The target area is the tracheobronchial tree
Endoscope, Accessories, Narrow Band Spectrum
Alternative mode of visualization using narrow bands from the visible spectrum for illumination and indicated for endoscopy and endoscopic surgery of the upper and lower diagestive tract and urinary tract.
The system consists of flexible and/or ridgid scope(s), light source(s), video processor and display
Enhances visualization of specific structures and reduces obscuring effects by using narrow bands of the visible spectrum for illumination. Narrow band illumination is accomplished through the modification of broadband light sources with optica
Limited to endoscopic systems for observation of the gastro-urological tract
Drill, Battery Powered, Subungual Hematoma
Intended to cut a hole in finger and toe nails to release fluid accumulated in the underlying nail bed.  Indicated to relieve pressure from subungual hematomas (including black toe).
The device is comprised of a hand-held cutter, sensing electrodes and a battery pack.
The device uses a 6V cutter motor to rotate the cutter and a 6V vertical drive motor to move the cutter towards and away from the nail. The motors are powered by a 9V battery.
Autoantibodies, Glutamic Acid Decarboxylase (Gad)
The device is used for the semi-quantitative determination of glutamic acid decarboxylase (GAD) autoantibodies in human serum as an aid in the diagnosis of Type I diabetes mellitus (autoimmune mediated diabetes).
Intended for use in soft tissue approximation.  Indicated for use in general soft tissue approximation and/or ligation.
Produced through recombinant DNA technology
To aid in management of patients treated with anti-seizure drug.
Immunoassay intented for use on clinical chemistry analyzers
Laparoscopic Bone Anchor Urethropexy Instrument Kit
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm0
Kit, Catheter, Urinary (Exludes Hiv Testing)
Urinary Catheterization Kit (Excludes HIV Testing)
Kit, Catheter, External, Male (Excludes Hiv Testing)
Male External Catheterization Kit (Excludes HIV Testing)
Kit, Catheter, Foley (Excludes Hiv Testing)
Foley Catheter Kit (Excludes HIV Testing)
Kit, Choledochoscope, Flexible And Rigid
Exempt laparoscope accessories are non-powered, non-inflatable, simple manual mechanical devices, e.g., cannula, graspers, forceps, dissectors, scissors, etc.  A gynecologic laparoscope is a device used to permit direct viewing of the organs wi
Part of a system where the accessories advance the working channel of the laparoscope to perform it's function.
Exempt hysteroscope accessories are non-powered, non-inflatable, simple manual mechanical devices, e.g., cannula, graspers, forceps, dissectors, scissors, etc.  A hysteroscope is a device used to permit direct viewing of the cervical canal and
Part of system that advances through the working channel of the hysteroscope to perform it's function.
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring
To reduce coronary artery stenosis by dilatation of the balloon and by apposition of the cutting/scoring surfaces to the stenotic material for the treatment of coronary artery stenosis to improve myocardial perfusion.
Cutting/scoring PTCA catheters are usually comprised of flexible polymers for the catheter body and a compliant polymer for the balloon.  The cutting/scoring elements are usually metal.
The device functions independently, but is typically placed using a guidewire and guiding catheter.  The balloon is inflated by the infusion of liquid through the body of the catheter.  Following treatment, the liquid is withdrawn, the balloon
Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies
Intended for the detection of IgM and IgG antibodies to dengue virus in human serum, plasma or whole blood.
Gas Chromatography, Bacillus Anthracis Membrane Fatty Acids
aid in the identification of Bacillus Anthracis
gas chromatography and pattern recognition
trypticase soy agar (with 5% sheep blood) bacterial cultures of any specimen type from the human body
The device moves the teeth by continuous gentle force for treatment of minor tooth malocclusion.
Device is composed of a thermoplastic resin.  It may also be accompanied by software and/or hardware for patient scanning.
Digital scans of patient's dentition are used to create a series of plastic appliances which are intented to progressively move teeth.
Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna
Novel influenza a virus reagents are used in nucleic acid amplification tests to directly detect and differentiate novel influenza a virus specific rna gene segments in human respiratory specimens or viral cultures. Detection and differentiatio
Special laser gas mixtures used as a lasing medium
Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion
Topoisomerase ii alpha (top2a) fluorescence in situ hybridization (fish) kit is to detect the top2a gene copy number changes (amplification and deletion) in breast cancer using formalin-fixed, paraffin-embeded human breast cancer tissue specime
Assay kit contains pre-treatment solution, TOP2A/CEN-17 probe mix, buffers, and fluorescence mounting medium
Fluorescence in situ hybridization, manual method
Formalin-fixed, paraffin-embeded human breast cancer tissue specimen
Intended to relieve nipples that are sore and cracked from breast feeding.
device is composed primarily of a cohesive gel
Intended to improve an individual's appearance only.  Not intended to assist in chewing food.
For implantation to reinforce and aid in reconstruction of the soft tissues of the eyelid.
Lyophilized sheets of SIS cut to various sizes
Natural collagen matrix which reinforces tissue and promotes cellular ingrowth
The device is used for the measurement, in human stool, of fecal calprotectin, a neutrophilic protein that is a marker of mucosal inflammation.  The device can be used as an aid in the diagnosis of inflammatory bowel disease (ibd), crohn's dise
A medication reminder is a device intended for medical purposes to provide alerts to patients or healthcare providers for pre-determined medication dosing schedules.  The device may incorporate wireless communication.
The device size can range from a handheld device to that of a desk or countertop device.
The device is electrically-powered, either battery or AC, and may incorporate wireless technology.
Target area depends on intended target area of the drug or drugs taken by the patient.
To improve speed, accuracy, and coordination of binocular eye movements and changes of accommodation.  To treat poor accommodation and vergence facility, convergence insufficiency, and accommodative lag.
Lights are spaced along a rod or positioned two-dimensionally on a screen.  Various materials are used for the rod or screen.
Multiple fixation targets move or alternate in preprogrammed sequences.
Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing
Prosthesis, hip, semi-constrained, metal/metal, resurfacing device relieves hip pain and improves hip function by replacing the parts of the hip that have been severely damaged by degenerative joint diseases.  This device is indicated for patie
The femoral resurfacing component and acetabular components are made of metal. These surfaces rub against each other (the bearing couple) and are made from highly-polished metal. This type of bearing couple is called a metal-on-metal bearing co
Prosthesis, hip, semi-constrained, metal/metal, resurfacing device has two parts: a socket in the shape of a shallow cup (acetabular component), and a cap in the form of a ball head (femoral resurfacing component).  The cup replaces the damaged
To be used as an aid in the detection or visualization of abnormalities of intraoral soft tissue.  An adjunct to traditional intraoral examination by incandescent light to enhance the visualization of oral mucosal abnormalities
The device consists of a light source with light guide cable or a handpiece based light emitting apparatus.  Added components may or may not block or filter out light inundesired frequencies.  The reflected light reveals tissue characteristics
The device emits a light in a specific wavelength range causing intraoral tissues to fluoresce or return or reflect light in another wavelength range in a detectable manner.
Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus
The s. Aureus pna fish is a qualitative nucleic acid hybridization assay intended for presumptive identification of staphylococcus aureus from blood cultures with gram-positive cocci in clusters (gpcc).  This device is not exempt per 21 cfr par
Kit box containing 1.5 ml Fixation Solution,  S. aureus-specific PNA probe in hybridization solution, Wash Solution and Mounting Medium. One-well microscope slides, fluorescent microscope equipped with a Dual Band Filter, and Control Slides are
Fluorescent In Situ Hybridization using protein nucleic acid (PNA) probes.
Fixture dental mount kit may contain hand instruments, drill bits, and screw drivers. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm
Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer
A device which uses a gene expression profile of a breast cancer tumor, from patients stage i or stage ii lymph node negative, with a tumor size of <5.0 cm, to provide a risk assessment for distant recurrence of breast cancer.  The result is in
RNA isolation kits, enzymes, fluorescent dyes, hybridization systems, computer
Uses Gene expression and computer algorithm that gives risk of recurrence.  Gene expression involves isolation of RNA from frozen tumor tissue sections, amplification of RNA and hybridization.
Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma)
Pmma diagnostic contact lens ophthalmodynamometer is intended to be applied for a short period of time directly on the globe or cornea of the eye for diagnosis of intraocular abnormalities.  The device is indicated for examination of the ocular
The contact lens consists of a curved shell of acrylic plastic (PMMA), which is adapted with electronic sensors for measurement of pressure applied to the eye.  The pressure values are displayed on a LCD display.
The examination PMMA contact lens is adapted with electronic sensors for measurement of pressure applied to the eye. The pressure values are displayed on a LCD display.
Handpiece, Air-Powered, Root Canal Irrigation
To clean the root canal prior to filling and used for root canal irrigation.
It is composed or aluminum, stainless steel and plastic
It is attached to the coupling for the dental handpiece and is used to provide irrigation solution into the root canal
It is used to treat a tooth during a root canal procedure
Stimulator, Electrical, Transcutaneous, For Arthritis
Electrical stimulation unit with leads and cutaneous electrodes used to apply an electrical current through electrodes on patient's skin to provide relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis).
Electrical stimulation unit with leads and cutaneous electrodes.
Applies an electrical current through electrodes on patient's skin.
Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody
The anti-rna polymerase iii test is a semi-quantitative elisa for the detection of anti-rna polymerase iii antibodies in human serum.  The test result is used as an aid in the diagnosis of systemic sclerosis (ssc) in conjunction with the clinic
Antibody ELISA kit, Antigen and Controls
The ELISA test result aids in the diagnosis of Systemic Sclerosis (SSc)
Chromogenic In Situ Hybridisation, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer
This device is intended to detect her2 gene amplification in formalin-fixed, paraffin-embedded breast carcinoma tissue sections using chromogenic in situ hybridization and brightfield microscopy.  Indicated as an aid in the assessment of patien
Wound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac)
A wound dressing with poly (diallyl dimethyl ammonium chloride) (pdadmac) additive is a device that is a sterile barrier wound dressing intended for use as a primary dressing for exuding wounds, first and second degree burns, and surgical wound
exuding Wounds and first and second degree burns
The device is intended to provide support to weakened or constricting airway walls and indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms or in benign strictures, after all alternative therapies have been
The device is a self-expanding tubular device, traditionally made of silicone. Devices can range roughly from 6-14mm in diameter and have lengths as small as 20 mm to lengths as long as 150mm.
The target area is the tracheobronchial tree.
Accessing the central vascular system for long term hemodialysis while reducing infection or thrombogenesis.
Circulates blood from the vascular system to a hemodialysis machine.  The coatings on the catheter reduce infection or thrombosis by local affects on the blood
Used to evaluate GI motility disorders and indicated for use in evaluating patients with suspected motility disorders.
Small ingestible capsule transmits motility data to a wireless receiver worn by the subject.  Data from the receiver is dowloaded into a personal computer (PC) and analyzed with custom software.
Ingestible telemetric capsule that transmits GI motility data to a wireless receiver worn by the patient.
Device is swallowed, and passes through the GI tract
Stimulator, Nerve, Electrical, Transcutaneous, With Limited Output, For Pain Relief
Electrical stimulation unit with leads and cutaneous electrodes
Stimulation of nerves using electrical current applied to electrodes on a patient's skin
Electrodes are placed on the skin in proximity to the painful area
Stimulator, Electrical, Transcutaneous, With Limted Output, For Aesthetic Purposes
Electrical stimulation for aesthetic purposes
Electrical stimulation using current applied to electrodes on a patient's skin
Electrodes are placed on the skin in proximity to the area of interest
Accessories, Germicide, Cleaning, For Endoscopes
High level disinfection of reusable, heat-sensitive devices    If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available
High level disinfection of reusable, heat-sensitive devices
Dna quality control material for genetic testing is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument v
This type of device includes synthetic DNA controls and cell-line based controls.
Approximately 3 cm tube placed in the prostatic urethra for short term use to drain urine.  The device includes a retention mechanism that anchors in the bladder neck to hold it in place and a release mechanism that exits the penis.  For short
Approximately 3 centimeter tube (i.e. length of prostatic urethra) that is inserted into the prostatic urethra and includes a proximal retention component that anchors the device in the bladder neck and a suture-type material on the distal end
The urethral stent crosses a partially or fully obstructed prostatic urethra to allow passage of urine.
Soft restraints to be attached to a backboard or stretcher in order to immobilize the patient in emgency situations.
fabric/nylon straps with velcro ends to be attached to the backboard
soft material restraint to be secured to the backboard/stretcher
Intended to monitor and reduce a patient's temperature to mild hypothermia (not to go below 32 degrees celsius.  To induce mild hypothermia in hyperthermic patients e.g., heat stroke, fever (excluding fever related to head injury, cardiac arres
Any application of external cooling methods (circulating water blankets/mattresses, circulating air blankets, cooling pads, cooling basins, etc.)
Intended for medical purposes designed for the use of a pediatric patient made of all construction materials used in a hospital nursery.
A remote medication management system provides a means for the patient's prescribed medications to be stored in a delivery unit; For a medical provider to remotely schedule the patient's prescribed medications; To provide notification to the pa
A remote medication management system consists of three primary components: control software (clinical and communications software), the medication delivery unit, and a specialized blister package containing the patient's prescribed medications
A clinician using the clinical software enters the patient's prescribed medication schedule.  The patient goes to a pharmacy and receives the prescription packaged in one or more blister pack discs.  The medication delivery unit then dispenses
Intended for delivery of pill type medication.
Respirator, N95, For Use By The General Public In Public Health Medical Emergencies
It is intended to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates during public health medical emergencies, such as influenza pandemic and also protects the wearer from splash
N 95 NIOSH-certified respirator made of known filtration materials arranged in layers
NIOSH-certified N95 respirator made of known materials
Stimulator, Low Electric Field, Tumor Treatment
Intended to treat tumors by application of low electic fields and indicated for treatment of recurrent glioblastoma multiforme (gbm) in patients who have received maximum standard therapy with continued disease progress, as defined by tumor gro
The device consists of sets of contact electrodes that are applied to the patient's shaved head, a connecting cable and a belt mounted control box and signal generator.  The sets are 3 electrodes each adn there can be 2 or 3 sets used at a time
This is a battery powered device.  Electric fields that alter thier polarity at a frequency near 200kHz with an intensity near 0.7 V/cm are continuosly applied to the target tumor 24 hours a day for 6 months at a time.  This electric field crea
The device is currently used only on the human head.
Intended to isolate the site of a surgical incision from microbial contamination and indicated to reduce the risk of skin flora contamination of the surgical incision throughout a surgical procedure.
Applied as a liquid film which dries to a polymerized, flexible film on the treated skin
Cyanoacrylate liquid film applied to the intended incision site dries to a flexible barrier film which immobilizes skin flora in the treated area
Skin surrounding a planned surgical incision
Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast
Indicated as a qualitative nucleic acid hybridization assay intended for identification of candida albicans from blood cultures with yeast.
Kit contains 3 ml bottle fixation solution, 1.5 ml bottle fluorescein labeled PNA probe in hybridization solution, 50 ml concentrated wash solution. One well, Teflon coated microscope slides available from manufacturer.
PNA probe is added to a fixed smear prepared from liquid blood culture media with yeast. Hybridization is performed during a 90 minute incubation at 55 degrees C in an incubator or slide warmer. The slide is examined by fluorescent microscopy w
Collector, Urine, Powered, Non Indwelling Catheter
For the non-invasive, non-sterile collection of urine and for patients unable to void on their own or have control of voiding.  Often patient confined to the bed or a wheelchair.
The device consists of a female designed cup, male cup, collection tubing, urine bag, pump, rechargeable batter, circuitry to control the operaton of the pump, software, and carrying case to be attached to a wheel chair or beside.
Urine is collected in a collection cup and with the assistance of a battery powered pump the urine is drawn through tubing into a urine bag for storage.
The collection cup is place under the external meatus of the urethra
Physically occupies spacewithin the vascular catheter and exerts pressure on the patient's blood to prevent blood from backfilling into the catheter and clotting.
Physically occupies space within the vascular catheter and exerts pressure on the patient's blood to prevent blood from backfilling into the catheter and clotting
Intended for use as a tool as part of a therapy regime for the low level light treatment of post mastectomy lymphedema and indicated for use as a tool as part of a therapy regime for the treatment of post mastectomy lymphedema.
Unit is a hand-held battery powered treatment device, is non-thermal and is used in the contact mode.
Device is non-thermal and delivers a controlled series of 200 ns bursts of pulses of 904nm laser beam, which is in the near infrared spectrum that is invisible to the human eye
Arms of women who have been treated for cancer and have developed post mastectomy lymphedema
To relieve the symptoms associated with motion sickness.
A camera and monitor or transparency are configured in such a manner so that the motion in the image as perceived by the passenger when the vehicle moves matches the motion felt by that passenger.
Low Energy Direct Current Thermal Ablation System
it includes the LEDC generator, electrodes and accessories
it applies a low energy direct current (LEDC) pulse or series of pulses between two electrodes to cause an ablation effect to occur
soft tissue including cardiac and smooth muscle
Plethysmograph, Air Displacement For Body Composition Analysis
To measure the total body volume and weight for calculating the estimated body composition (total body fat and total body lean mass).
An air-tight, dual compartment fiberglass and plexiglas chamber that the subject enters
Uses Boyle's law in conjunction with the two precisely-sized compartments to determine the volume occupied by the subject's body.  Average total body density is calculated from the weight and volume determined by the device. Empirical equations
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
The device is an ablation catheter that features electrodes through which thermal energy is delivered.
The ablation catheter delivers energy to the specific region of the heart in order to create lesions that will treat the patient of atrial flutter.
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
For the treatment of atrial fibrillation.
The ablation catheter delivers energy to the specific region of the heart in order to create lesions that will treat the patient of atrial fibrillation.
Implant, Hearing, Active, Middle Ear, Totally Implanted
Intended to provide useful hearing to persons with sensorineural hearing loss. Indicated for adults with mild to severe sensorineural hearing loss who have a speech discrimination score greater than or equal to 60%.
All components: microphone, sensor, electronics, audio processor, battery and driver are hermetically sealed inside the housing and implanted.  Programming accessories are separate.
Garment, Storage, Peritoneal Dialysis Catheter
To store the external peritoneal catheter portion between treatment sessions and to support, stabilize, and improve the care and cleanliness of the peritoneal catheter and reduce the need to use tape on the skin.
Holds the catheter tube in a cloth sleeve wrapped around the patient's abdomen.
External to the body around the abdomen.
Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis
E. Faecalis pna fish is a qualitative nucleic acid hybridization assay intended for the identification of enterococcus faecalis and other enterococci (oe) from blood cultures showing Gram-positive cocci in pairs and chains.
A mixture of fluoroscein-labeled E. faecalis specific PNA probe and a rhodamine-labeled PNA probe specific for Enterococcus species is added to a fixed smear prepared from a positive blood culture showing gram positive cocci. Hybridization is f
E. faecalis PNA FISH is a multicolor fluorescence in situ hybridization method using protein nucleic acid probes hybridizing to E. faecalis-specific ribosomal RNA sequences and to ribosomal sequences of other Enterococcus species.
Smears made from positive blood cultures showing gram positive cocci.
Consists of primers, probes, enzymes and controls for the amplification and detection of enterovirus RNA in cerebrospinal fluid (CSF) from individuals who have signs and symptoms consistent with meningitis or meningoencephalitis.  The detection
Nucleic acid amplification assay system, self-contained cartridge with dedicated instrument.
Enterovirus (EV) RNA (enterovirus genome 5 prime untranslated region (UTR) between nucleotides 452 and 596)
To allow continuous drainage of saliva and/or fluid irrigation of the salivary duct as well as assisting in maintaining duct patency during the healing process following removal of salivary gland stones for temporary insertion into the salivary
It is a flexible, single lumen, disposable drainage cannula made of radio-opaque polyurethane material
The drainage cannula is inserted which allows the fluid to drain following endoscopic removal of salivary gland stones
Immunoassay, Insulin-Like Growth Factor Binding Protein-1
The device is a qualitative immunochromatographic test for the detection of amniotic fluid in cervicovaginal secretions.  The test is intended for professional use to help diagnose the rupture of fetal membranes in pregnant women.
The kit contains multiple test packs, each containing one sterile polyester swab for specimen collection, one tube of Specimen Extraction Solution, and one dipstick in a sealed aluminum foil pouch.
The test is based on immunochromatography.
Cervicovaginal specimens are collected and used on the device.
A cranial orthosis is a device that is intended for medical purposes to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape.  A laser scanning accessory may be used to create a scan of th
Cranial orthotics are custom-made for each patient's head.  They are typically made from plastics, foam and velcro.
A mold is made of the baby's head to create the orthotic.  Plaster or laser scanning may be used to create the mold.
Cord Blood Processing System And Storage Container
A cord blood processing system and storage container is a device intended for use in the processing and the storage of cord blood. This device is used as a functionally closed processing system by cord blood establishments.  This device include
Compact disc containing broadband pink noise.
Injector, Vertebroplasty (Does Not Contain Cement)
Intended for injection of vertebroplasty bone cement for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign l
plastic syringe type device -- some embodiments may include levers or screws to increase injection force or control
Uses mechanical force to inject  bone cement into vertebra
It is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth.  It is used temporarily and is removed after orthodontic treatment has been completed.
Generally fabricated from titanium or titanium alloy in a screw form or screw and plate combination.
It is surgically placed in the bone of the upper or lower jaw arches to provide support for orthodontic devices.
Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma
The test is intended to quantitatively measure dcp in human serum and use as an aid in the risk assessment of patients with chronic liver disease for progression to hepatocellular carcinoma (hcc) in conjunction with other laboratory findings, i
An assay kit containing specific antibodies, substrates and reaction columns
An in vitro diagnostic reagent system intended for use in the quantitative determination of total mycophenolic acid in human serum or plasma as an aid in the management of mycophenolic acid therapy in renal and cardiac transplant patients.
Enzyme-mimicking assay with MPA concentration inversely proportional to the formation of NADH.
Cancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Epithelioid/Biphasic Mesothelioma
A quantitative measurement of soluble mesothelin related peptides (smrp) in human serum.  Measurement of smrp may aid in the monitoring of mesothelioma patients diagnosed with epithelioid or biphasic mesothelioma. Values must be interpreted in
Assay kit including capturing and detecting antibody, buffers, controls and calibrators.
In vitro diagnostic test usinh human serum.
For the detection of plasmodium spp. Antigens in venous or capillary whole blood.  To aid in the diagnosis of human malaria infections and/or to aid in the differential diagnosis of plasmodium falciparum infections from other less virulent plas
In vitro diagnostic immunochromatographic membrane assays or lateral flow assays that uses  antibodies to detect specific antigens.
Light Source System, Diagnostic Endoscopic
A fluorescence system intended for use as an adjunct to white light cystoscopy when used in combination with a photosensitizer for the detection of bladder cancer.  Patients with known or suspected bladder cancer and/or recurrence of bladder ca
System includes a PPD light source, specific PDD telescopes for cystoscopy), camera system (PDD camera control unit, and PDD camera heads) fluid light cable, and PC based software communication program
1.	excitation and emission filters in the PDD telescopes and PDD camera heads  limit light to the blue portion of the visible spectrum The combination of these 2 filters in conjunction with the photo- fluorescent drug Hexvix? enables visualizat
To restrict air flow to the target section of the lung.  To control prolonged air leaks of the lung, or significant air leaks that are likely to become prolonged air leaks, following lobectomy, segmentectomy, or lung volume reduction surgery (l
This device is a small nitinol frame that has a polyurethane membrane over the Nitinol frame that acts as a plug to the targeted section of the lung.
The device is a nitonal frame with a polyurethane membrane over the Nitinol frame. The valve does not allow air into the targeted segment of the lung, but does allow air and mucus out of that lung section.
The device is intended to occlude a section of lung.
The neurovascular embolization device is placed in a blood vessel to permanenty obstruct blood flow to an intracranial aneurysm or other vascular malformation.   The device polymerizes or precipitates in situ.
the embolization agent is dissolved in DMSO (dimethyl sulfoxide, an organic solvent); ethylene vinyl alcohol co-polymer (EVOH, the embolization agent) upon contact with aqueous solutions such as blood or saline, precipitates in situ forming a s
intracranial aneurysms as specified by indication statement
sperm friendly moisturizer samples (Pre Lubricant); 1 conception journal; 1 instruction manual; 2 conception wheels (1 in English and 1 in French); 1 medical provider envelope.
sperm friendly moisturizer samples (Pre Lubricant); 1 conception journal; 1 instruction manual; 2 conception wheels (1 in English and 1 in French); 1 medical provider envelope.  All device contents have been previously cleared through pre-marke
During sexual intercouse, sperm is collected in a polyurethane semen collection device (condom).  Immediately thereafter, this sperm is transferred to the bowl of a cervical cap (made of silicone elastomers).  This cap is placed on the cervix f
Sperm, uterine horn, vagina and embryo (if any) have the potential to be affected by this device.
For temporarily occluding vessels during anastomosis procedures.
liquid at room temperature and gel at body temperature
The material is thermosensitive such that it forms a gel when injected into the blood vessel, and remains gelled for the period it takes to make the anastomosis
Indicated to reduce the incidence, severity or extent of adhesions/tissue attachment in cardiovascular surgery by providing a plane of dissection or mechanical barrier between opposing surfaces of tissue and/or devices.  Intended for use in car
a resorbable synthetic polymeric material that is either a sheet of material or a spray liquid
the barrier may be either placed in the area of concern, or sutured in place, or sprayed onto the area
The device is used for the detection, in human serum or plasma, of autoantibodies to SS-A 52.  The detection of SS-A 52 autoantibodies may aid in the diagnosis of systemic lupus erythematosus, Sjogren's syndrome, systemic sclerosis, polymyositi
The device consist of components/reagents to detect and semi-quantitatively measure autoantibodies to SS-A 52.
Enzyme-linked immunosorbent assay (ELISA) or enzyme immunoassay (EIA)
The assay is performed by testing human serum or plasma.
In vitro diagnostic device for qualitative detection and classification of 8 clinically relevant Hepatitis C Virus RNA genotypes
Monitor, Extracellular Fluid, Lymphedema, Extremity
Measure impedances in affected and unaffected but opposite extremity to periodically monitor the level of extracellular fluid or the differences in bioimpedance between opposing extremities for patients who have been previously diagnosed with u
Electronic black box/monitor with keypad or other interface and display having the ability to connect to four electrodes and computer
Applies a small alternating current of one or more frequencies through electrodes attached to particular locations on the skin surface of the subject's body and then measures/calculates level of bioimpedance indicated by living tissue over the
To measure pressure within the cardiovascular system.
The catheter uses sensors which directly measure the pressure.
For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.
Catheter with ultrasound sensors that is used with an imaging system to display ultrasound image.
Intended to cushion and protect the localized area surrounding the implanted port and indicated for subjects having implanted subcutaneous or intravascular infusion ports.
Device is a foam ring with adhesive that is placed on intact skin over the port access site. The foam ring can be any defined shape that covers the port. The foam provides a barrier to the implanted port.
Device is applied on top of intact skin and provides a protection barrier over the implanted port.
Cement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty
Reduction of vertebral body fractures in conjunction with PMMA bone cement cleared for vertebroplasty and restoration of vertebral body height.
Interlocking pre-formed polymeric (e.g., PEEK) components sized to the desired vertebral body dimensions
Implanted modularly within the vertebral body until desired height is achieved, then encapsulated in PMMA.
Cement, Bone, Vertebroplasty, Pre-Formed, Modular
Interlocking pre-formed PMMA components sized to the desired vertebral body dimensions
Implanted modularly within the vertebral body until desired dimensions are achieved, then encapsulated in PMMA
Humidifier, Respiratory, Mask (Direct Patient Interface)
Intended to moderate blood pressure in hypertensive patients when they are exposed to the cold. The mask attenuates (moderates) the physiological response, increases in blood pressure, associated with cold exposure, by warming the inhaled air d
A simple mask that is placed over the patient's nose and mouth, and held in place with an elastic band around the back of the head.
Viewing, imaging, measurement, and analysis of ocular structures.  Diagnostic device to aid in the detection and management of various ocular diseases.
Computerized imaging device consisting of light sources and beam delivery and scanning optics.
Cross sectional tomograms of ocular structures are obtained using non-invasive, non-contact, low-coherence optical interferometry.
To protect the teeth and reduce damage caused by bruxing or nighttime grinding and prevention of the noise associated with bruxing and grinding.
It is a material similar to a hard methylmethacrylate or a softer thermoplastic resin.
The dental mouthguard is a removable appliance that is fitted to the teeth by taking an immpression of the teeth or using a thermoplastic resin
Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
Intended to redirect the angle of growth of long bone(s) only in pediatric patients. Indicated for temporary or permanent epiphysiodesis.  For gradually correcting angular deformities of long bones in pediatric patients with an open physis.  Sp
Metallic bone fixation appliances and accessories
Long bone growth plates only.  Spinal indications require additional testing, labeling and an different product code.
A conditioning tool for eating disorders is a medical device that non-invasively measures the mass of food eaten during a meal and provides feedback in the form of eating rate, patient satiety, and eating pattern information to the patient.
A flat scale is connected to a monitor which records data and displays the food consumption rate.  The monitor also prompts the user for satiety sensation and displays trend.
Uses scale to meaure weight of plate during meal.  Prompts user to provide feedback on satiety during meal.  Provides display for actual and target food consumption rate.
The test kit is an enzyme-linked immunoassay (elisa) to determine levels of 11-dehydro thromboxane b2 (11dhtxb2) in human urine, which aids in the qualitative detection of aspirin effect in apparently healthy individuals post ingestion.  For pr
An enzyme linked immunosorbent assay (ELISA) for the detection of 11dhTxB2.
A female condom is a sheath-like device that lines the vaginal wall and is inserted into the vagina prior to the initiation of coitus. It is indicated for contraceptive and prophylactic (preventing the transmission of sexually transmitted disea
A sheath like device made from animal tissue, with retention mechanisms as to stay in place during coitus.
Provides a thin film barrier to sperm and std microorganisms.
The alpha-1-antitrypsin qualitative phenotype test result is used as an aid in the diagnosis of alpha-1-antitrypsin deficiency in conjunction with clinical and other laboratory findings. For in vitro diagnostic use only.
A1AT Antibody Isoelectric focusing gel qualitative phenotype kit and A1AT qualitative phenotype control
Isoelectric focusing gel qualitative test.
Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection
A gene expression test for detection of cancer metastasisis an in vitro diagnostic test performed on tissue of interest from patients previously diagnosed with cancer.  Results from the test can be used to guide the intra-operative or post-oper
Test consists of reagents, instrumentation, software and instructions needed to perform the test method.
In vitro replication, amplification and detection of mRNA representing the product of one or multiple genes from a cancerous tissue of interest.
Human tissue from known cancer patients, removed during biopsy procedures for detection of cancer metastases.
Respiratory Virus Panel Nucleic Acid Assay System
A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture.  The det
A qualitative in vitro diagnostic assay intended to simultaneously detect, identify, and/or differentiate multiple respiratory virus nucleic acid extracted from human respiratory specimens or viral cultures.  Detection and differentiation of sp
Interactive wound and burn dressing containing a live xenogeneic component.  Indicated for use in patients who have deep dermal or full thickness burns comprising a total body surface area of greater than or equal to 30%.  It may be used in con
Epicel cultured epidermal autografts (CEA) is an aseptically processed wound dressing composed of the patient?s own (autologous) keratinocytes grown ex vivo in the presence of proliferation-arrested, murine (mouse) fibroblasts.  Epicel consists
Patient's own cells are in vitro cultivated and expanded in number into a graft/dressing design in sufficient size to facilitate coverage of the burn injury.
Stimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief
Electrical stimulation of nerves for relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis). Relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis).
Applies an electrical current through electrodes on a patient's skin.
Electrodes are placed on the skin to stimulate nerves in proximity to the painful joint.
Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented
Call for PMAs to be filed by 1/3/05 per 69 FR 59134 on 10/4/04 - Intended to replace the articulating surfaces of the hip while preserving the femoral head and neck and indicated for osteoarthritis, rheumatoid arthritis, traumatic arthritis, av
This generic type of device includes prostheses that consist of a femoral cap component made of a metal alloy, such as cobalt-chromium-molybdenum, or a ceramic material, that is placed over a surgically prepared femoral head, and an acetabular
The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint.
Solely for use with sporting and aviation activities.  Intended to monitor heart rate during exercise.
The time-temperature indicator provides a visual signal that a selected time-temperature profile has been exceeded.  When affixed to a device, a time temperature indicator is indicated, via a permanent color change, for the purpose of distingui
Plastic label stock, with adhesive backing. Reference and active inks are deposited upon the plastic stock. The reference ring is printed with UV curable ink or a solvent-based ink, depending on the substrate. The active ink contains a suspensi
The mode of operation is through the solid state polymerization of diacetylenes (DAs) to form poly(diacetylenes) (PDAs).
Create channels in the existing spinal bone structure for the flow of polymethylmethacrylate bone cement (PMMA) prior to a vertebroplasty procedure.  Treatment of pathological compression fractures of the vertebral body that may result from ost
Composed of cannula for placement within the vertebral body and cutting element that is deployed by the surgeon once the cannula is placed.
Device placed within cancellous bone of vertebral body and then cutting element advanced forward out of device by surgeon to create channel for cement flow.
Transurethral Occlusion Insert, Urinary Incontinence-Control, Female
Transurethral insert for urinary occlusion/control in women with urinary incontinence
balloon tipped catheter, insertion device
A balloon tipped catheter is inserted into the urethra. Deflation or removal of the device results in fluid movement
Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
Surgical device for cutting, coagulation, and/or ablation of tissue, including cardiac tissue
The device tip delivers energy to provide cutting, coagulation, and/or ablation of the contacted tissue
The device energy source used to provide cutting, coagulation and/or ablation may be radio frequency (RF), cryogenic, laser or ultrasound
Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
Surgical cardiac ablation for the treatment of atrial fibrillation.
The device is used for the semi-quantitative determination of insulin autoantibodies in human serum as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes) in patients who have not received insulin therapy.
A device to be used in the prophylactic treatment of medically diagnosed migraine pain as well as migraine associated tension-type headaches, by reducing their signs and symptoms through reduction of trigeminally innervated muscular activity, a
Mouthguard repositions the jaw to reduce muscle tension
Laparoscopic Bladder-Neck Suspension Instrument, Stress Urinary Incontinence
For female urinary stress incontinence due to hypermobility
may include: template assembly, suture retriever, suture cutter, suture placement system
The lung sound monitor is intended for use in monitoring and recording lung sounds.
The device consists of the arrays of electronic stethoscopes to collect the sound, a digital collector module, and is connected via cable to a PC workstation.
Uses electronic stethoscopes placed in an array on the pts. back to record sounds within 100-250Hz, the sounds recorded are converted from analog to digital, and through software, displayed in a gray-scale image.
Posterior thorax to record sounds emanating from the lungs.
May include: ccd camera, monitor, other software or hardware associated with video equipment, and components from other regulations, such as a pump.
various body cavities, hollow organs, and canals in GI and GU tract
Anti Fog Solution And Accessories, Endoscopy
To prevent, reduce or eliminate condensation (fog) on endoscopic lens.
anti fog solution; applicator- typically a foam pad or sponge, spray can, bottle, or cloth; container to hold solution
Apply solution to lens, typically by spraying or wiping.
To protect delicate parts of the endoscope during transport and storage. May also be used to protect during sterilization.
Placed over endoscope or parts of the endoscope.
To hold endoscope in a desired position during procedures.
To aid in endoscopically placing sutures, staples, clips, and other fastening tools through tissue.
may include: delivery instrument, applier, holder, connector, threading tool, needle-loading tool, ring implant, pin implant, knot pusher, sutures, staples, clips, tackers, fasteners
Many methods to perform intended use. Insert instrument through endoscope at desired area of delivery.
Various tissues located within body cavities, hollow organs, and canals in GI and GU tract.
To supply sterile water, other solutions and/or suction to endoscopes during endoscopic procedures.
may include: pump, motor, tubing, controller, air switch, power supply, transducer, digital display, suction attachment, bottle cap
Connects to tubing from pump and goes down working channel of endoscope
To provide access to gi or gu tract for the purpose of passing or exchanging other accessories.
metal guidewire with or without polymer coating, and associated guidewire accessories
placed through working channel of endoscope
To manually grasp stones, tissues or other objects through an endoscope. To manipulate, sample or cut tissues through an endoscope.
Non-electric and non-magnetic devices. May include: grasping or retrieval forceps, biopsy forceps or other sampling tools, scissors, stone basket, stone dislodger
Place through an endoscope to reach desired area.
various tissues, stones or other foreign bodies within GI and GU tract.
To control endoscopic and other ancillary surgical equipment in one central location, either by remote control, touch screen, or voice command.
may include: monitor, remote (or other wireless device), microphone, card adaptor, cables, other hardware and software
Connect operating systems into central control unit
endoscopic and other ancillary surgical equipment
To protect an endoscope from contamination by providing a barrier between the body and the endoscope.
Placed over endoscope before insertion into the body
To give the endoscope channel additional or improved functionality.
may include: biopsy cover, biopsy cap, external accessory channel, anti splatter device, locking device,
Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula
To identify stones, tumors, or narrowing in the biliary tree.
catheter. may include radiopaque markings
Passed through an endoscope (duodenoscope) into the biliary duct to inject x-ray contract media into the biliary tree.
Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
To treat the symptoms of chronic gastroesophageal reflux disease (GERD), either by approximating tissue with sutures or plicating tissue with an implant.
may include: capsule assembly, needle assembly, guidewire, suture cutter, tubing, clip delivery device, clips or other implant, plication instrument, overtube, retractor
Place sutures in soft tissue of stomach and esophagus, or deliver implant in stomach near gastroesophageal junction
To examine and perform procedures in body cavities of the GI and GU tract.    If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26
May include: handle, scope, fiberoptic attachment. Usually modular in nature. May be custom built
Can be placed through working channel of a full sized endoscope. May also be used as a stand alone device
various body cavities in the GI and GU tract
To provide ultrasonic visualization of body cavities that can be accessed by endoscope.    For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k)
ultrasound system and system accessories, endoscope
Uses ultrasound to visualize body cavities through endoscope
Implantable Bladder-Evacuation Electrical Stimulation System
To provide urination on demand and to reduce post-void residual volumes of urine in patients who have clinically complete spinal cord lesions (asia classification) with intact parasympathetic innervations of the bladder and are skeletally matur
May include: electrodes, implantable pulse gnerator, battery charger, programmer or transmitter, surgical components
Temporary closing IV administration set.  Temporary aseptic closure of the male Luer connector of the IV tubing in between uses for the life of the administration set.
Housing is made of polyethylene, piston is made of silicone
Temporary barrier against airborne contaminants
indirect contact, intravascular administration of fluids
Intended for the reduction or elimination of myopia and astigmatism in patients with keratoconus so that their functional vision may be restored and the need for a corneal transplant procedure may be potentially deferred.
Two clear polymethylmethacrylate segments, each having an arc length of 150 degree.
When placed in the corneal stroma outside of the patient's central optical zone, the product reduces the cone by flattening the cornea and for non-central keratoconus repositions the cone centrally.
Ultrafiltration-Controlled Nocturnal Dialysate Delivery System
Hemodialysis performed with a high permeability hemodialyzer and an ultrafiltration-controlled system.  Nocturnal hemodialysis for patients with end-stage renal disease (chronic dialysis) or acute renal failure (acute dialysis) performed with a
Device is an electronic, software-controlled system with a user interface.  Device can include extracorporeal tubing sets, but not necessarily.
Device consists of a system of pumps, valves, sensors, monitors and other components that direct blood through a dialyzer so that hemodialysis may be performed.
Device is an extracorporeal device treating patients' blood.
Intervertebral Fusion Device With Bone Graft, Cervical
Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
Hollow cylinder or rectangular box made of metal or polymer.
Ground pad used to finish circuit during electrosurgery.  A single use, non-sterile dispersive electrode with a pre-attached cord used to adhere to the patient over the entire pad surface to complete the electrosurgical circuit between the gene
The electrode consists of five distinct layers of materials: the Mylar (protective cover) which is removed prior to use, Gel, Aluminum, Acrylic Adhesive and Blue Foam. The electrode construction consists of a dual aluminum electrode which conne
Electrosurgical Patient Return Electrode is a single use, non-sterile disposable electrode with and without a pre-attached cord. The use is to complete an electrical circuit during electrosurgery between the generator, the active electrode, and
Wound covering.  Indicated for use in patients with mitten hand deformities due to recessive dystrophic epidermolysis bullosa (rdeb) as an adjunct to standard autograft procedures (i.E., skin grafts and flaps) for covering wounds and donor site
For use as an adjunct in the surgical repair of thoracic aortic aneurysms.
a two-part liquid that is mixed just prior to use
the adhesive is introduced into the false lumen after collapsing the false lumen to minimize the amount of adhesive needing to be dispensed
For use in plastic and reconstructive surgery. The devices can be used for cosmetic augmentation and corrections of soft tissue deformities in the face, including areas such as the nose, chin, and cheeks.
Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System
An in vitro diagnostic assay for use in genotyping vitamin k epoxide reductase complex subunit one (VKORC1) alleles to aid in the identification of patients at risk for altered warfarin sensitivity.
Uses DNA genotyping technology to determine patient genotype at the Vitamin k epoxide reductase complex subunit one (VKORC1) gene locus.
clinical samples (blood, saliva, buccal swab samples)
Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System
An in vitro diagnostic assay for use in genotyping Cytochrome P450 2C9 (CYP450 2C9) alleles.  Information about the CYP2C9 genotype may be used as an aid to clinicians in determining therapeutic strategy for medications that are metabolized by
Uses DNA genotyping technology to determine patient genotype at the Cytochrome P450 2C9 (CYP450 2C9) locus.
Autonomous Extracorporeal Blood Leak Detector/Alarm
To detect the presence of blood leaking from an extracorporeal connection or needle site in hemodialysis patients and alert the user or attending staff.  The device detects colormetric, chemical, or light modulation caused by exposure to leakin
black box with a strap that is attached to the patient's arm.  The device has visual indicators with accompanying audible alarm
An optical fiber is connected to an infrared source at one end and an infrared receiver at the other end.  In the middle of the fiber is a sharp bend that is covered with an absorbent pad.  Blood absorbed into the pad will cause the intensity o
Usually the forearm but could be placed anywhere a blood line and needle are attached to the body.
To assist in the removal of tunneled long term catheter cuffs using a minimal invasive technique by seperating the tissue ingrowth cuff from the surrounding tissue. Following seperation of the cuff from the tissue, the catheter can be safely re
The device is made of a rigid or semirigid material and is designed to be able to snap over the catheter body. The deivce may have a hinge or handle to assist in holding the device and manipulating the removal function during operation.
The device is designed to snap over a catheter body and to be guided over the cather through the insertion site and into the subcutaneous tissue where the catheter tissue cuff is adhering to the tissue. The user of the catheter removal device,
Tunneled Catheters with tissue ingrowth cuffs.
A gown intended to protect health care patients and personnel from the transfer of microorganisms, body fluids and particulate material
An isolation gown is made of fabric material, either non-woven or woven
Serves as physical barrier to the transfer of microorganisms, body fluids and particulate material. Level of barrier protection is nonspecific.
An isolation gown covers the torso and clothing and poses a physical barrier to the transfer of microorganisms, body fluids and particulate material
Device is a replacement cuff to be used in conjunction with a non-invasive blood pressure monitor.  Together the devices determine blood pressures and heart rate.  This particular cuff contains an embedded antimicrobial.  A blood pressure cuff
The device is a typically a textile enfolded over an inflatable bladder.
The blood pressure cuff wraps around the subject's arm or wrist and the bladder is inflated.  The pressure from the bladder occludes the artery.  When the pressure is slowly released, the Korotkoff sounds or oscillometric wave form produced is
The cuff is placed either over the upper arm, wrist, or thigh.
As an adjunctive tool to guide the shavings of tissue at the margins of the tumor for use in excisional breast surgery to assist in locating the tissue for excision. In addition to other standard methods such as intraoperative imaging and palpa
It utilizes electromagnetic waves to characterize human tissue in real-time. It consists of a console and a disposable hand-piece.
Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230
The device is intended as an aid in the diagnosis of bullous pemphigoid.
Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit
To aid in the diagnosis of individuals presenting with signs and symptoms of pneumonic or typhoidal tularemia with a qualitative in vitro diagnostic (ivd) detection of target dna sequences of francisella tularensis.
Kit contains 6 vacuum-sealed pouches of freeze-dried PCR reagents, containing 4 vials each, and six pouches containing one tube each of reconstitution buffer and reagent grade water.  Designed to be used on the JBAIDS instrument (K051713).
Real-time polymerase chain reaction (PCR)amplification and detection system.
Matrices: whole blood, sputum, colony and blood cultures.
A tubular drain made from silicone or similar material and is coated with a silver containing material and is intended to drain fluids from body cavities using gravity drainage or attached to a suction pump.
A tubular drain made from silicone or similar material and is coated with a silver containing material
Gravity drainage or attached to a suction pump
Normally any body cavity following surgery
Laser ablation of prostatic tissue for the treatment of benign prostatic hyperplasia
The device consists primarily of medical laser and deliver fibers.  The fibers are positioned in the prostate or prostatic urethra through endoscopy and direct laser optical energy into the prostate.
Laser optical energy is applied to the prostate using endoscopically delivered fibers.  Heating of the prostatic tissue leads to necrotic death or direct ablation depending on the temperatures achieved.
Human Metapneumovirus (Hmpv) Rna Assay System
A qualitative in vitro diagnostic assay intended to detect human metapneumovirus (hmpv) rna extracted from human respiratory specimens or viral cultures. Detection of hmpv rna aids in the diagnosis of respiratory hmpv infection in conjunction w
Human metapneumovirus (hMPV) RNA detection assay systems are devices that consist of reagents and instruments for the detection of hMPV RNA extracted from human respiratory specimens or viral cultures.
A qualitative in vitro diagnostic assay intended to detect human metapneumovirus (hMPV) RNA extracted from human respiratory specimens or viral cultures.
Influenza A Virus Subtype Differentiation Nucleic Acid Assay
A qualitative in vitro diagnostic assay intended to detect and differentiate between influenza a virus subtypes in human respiratory specimens or viral culture.  Detection and differentiation of specific subtype rna aids in the diagnosis of inf
Cardiovascular Catheter Sheath Introducer Kit
Devices are intended to record and analyze single-lead electrocardiograms.  Devices only display interval values to the user.  Devices are intended for over-the-counter sale.  Devices are indicated for users who wish to monitor common ECG inter
Battery-operated, Plastic Case, Metal electrodes, Liquid Crystal Display
Records single-lead electrocardiogram through two or three electrodes.  Automatically analyzes waveform for common, clinically-accepted intervals.
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  The convenience kit, as listed in the guidance above, is u
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  The convenience kit, as listed in the guidance above, is u
Anesthesia Breathing Circuit Kit (Adult & Pediatric)
Restorative Instrument And Component Tray
Blood Specimen Collection Kit (Excludes Hiv Testing)
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This kit, as described in the guidance above, is under enf
An intraocular pressure lowering implant is a device intended to reduce intraocular pressure when implanted in eyes which have not failed conventional medical and surgical treatment.
This device category includes various materials, both biodegradable and non-biodegradable, and includes devices of various designs.
An intraocular pressure lowering implant uses various methods such as increasing aqueous outflow to reduce intraocular pressure
Contents typically includes:  Ear piercing instrument, alcohol prep pads (pro code: LKB - unclassified), ear piercing studs.  This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interi
Catheter, Intravascular, Plaque Morphology Evaluation
Catheter used for delivery of a sensing modality to a coronary or peripheral artery region for determination of atherosclerotic plaque characteristics.  For examination of morphologic features of coronary or peripheral artery lesions or plaques
Flexible intravascular catheter with plaque diagnostic modality at the tip.
The device is inserted into the arterial segment of interest, and using its sensing technology, obtains information on the characteristics of the arterial wall.  The characteristics are captured digitally and filtered with a software algorithm,
Heart Valve, More Than Minimally Manipulated Allograft
For the replacement of diseased, damaged, malformed or malfunctioning native or prosthetic pulmonary heart valves.  They may also be used in the replacement of native pulmonary heart valves when the ross procedure is performed.  Pulmonary heart
The allograft heart valve has been more than minimally manipulated.
The allograft heart valve replaces the native or prosthetic pulmonary heart valve.
Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea
Intranasal device that creates expiratory resistance for the treatment of obstructive sleep apnea.
plastic with adhesive; valve that changes position with inspiration/expiration to provide decreased/increased resistance
intranasal device that creates expiratory resistance
inserted into nares of nose to maintain upper airway pressure.
A quality control material (unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical
Light Based Over The Counter Wrinkle Reduction
Use of light based treatment to reduce  wrinkles on the body in general or specific anatomical locations depending on the information provided.
The device can be hand held or mounted on a support system like a stand or mechanical arm.  The device will emit light that can be monochromatic or narrow band or broad band.  The light energy may be very low to moderate power levels.
Uses light based energy delivered to and or through the skin to effect change in the tissue that results in the reduction of wrinkles.
Mostly intended to be used on the human face, head, and neck.
Light Based Over-The-Counter Hair Removal
Over-the-counter device uses thermal energy to kill hair follicles for hair removal.
Use of thermal energy to kill hair follicles for hair removal
The device generally targets skin (including dermis, epidermis), underlying   soft tissue and hair follicles.
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
A device using focused ultrasound to produce localized, mechanical motion within tissues and cells for the purpose of producing either localized heating for tissue coagulation or for mechanical cellular membrane disruption intended for non-inva
Burr, Corneal, Battery Powered, Rust Ring Removal
A powered corneal burr is an AC-powered or battery-powered device that is a motor and drilling tool intended to remove rust rings from the cornea of the eye and is class I exempt when intended only for rust ring removal.
Burr, Corneal, Ac-Powered, Rust Ring Removal
A device used to cut or crush medication to aid in consumption.  The device is intended to only be used with medications that are labeled as acceptable for crushing or cutting.
The device is aluminum/stainless steel with a handle, linkage arm, and anvil that are connected to pivot points by steel pins.
Urine Transport Kit (Excludes Hiv Testing)
Neonatal Blood Collection Kit And Screening Form (Excludes Hiv Testing)
Blood And Urine Collection Kit (Excludes Hiv Testing)
Blood Alcohol Kit (Excludes Hiv Testing)
Sex Crimes/Sexual Assault/Suspect Evidence Collection Kit (Excludes Hiv Testing)
Urine Collection Kit (Excludes Hiv Testing)
Tyrosine Phosphatase (Ia-2) Autoantibody Assay
The device is used for the semi-quantitative determination of autoantibodies against tyrosine phosphatase (IA-2) in human serum as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes).
Powder-Free Guayle Rubber Examination Glove
A disposable patient examination glove made from guayule natural rubber latex. This alternative source of natural rubber latex (guayale) does not contain the same protein associated with allergic reactions to latex products from the hevea rubbe
The device is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
Yersinia spp. reagents are devices that consist of Serological Reagents and Nucleic Acid Amplification Reagents to differentiate Yersinia spp. and presumptively identify Yersinia pestis (Y. pestis) from cultured isolates or clinical specimens.
Kit includes primers, probes, enzymes and specific controls for amplification and are designed for use with specific instrument systems.
The device is intended for use in patients with stable, high spinal cord injuries with stimulatable diaphragms, but who lack control of their diaphragms. The device is indicated to allow the patients to breathe without the assistance of a mecha
implanted electrodes, stimulator control, clinical programming station
provides electrical stimulation for diaphragm movement
Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation
To fill traumatic or surgically-created defects not intrinsic to the stability of the bony structure.  It is delivered to the defect and resorbs over time to be replaced by bone.  Not for screw augmentation.
bone void filler and mixing and delivery system
various, specified bone voids (e.g., extremeties, pelvis)
Test, Epithelial Ovarian Tumor Associated Antigen (He4)
An enzyme immunometric assay for the quantitative determination of HE4 in human serum.   The assay is to be used as an aid in monitoring recurrence or progressive disease in patients with epithelial ovarian cancer. Serial testing for patient HE
dual-site sandwich enzyme immunoassay of human serum or plasma; may be measured by stand-alone spectrophotometer or automated immunoassay analyzer
Dental amalgam is a device that consists of a metallic alloy, such as silver, tin, copper, and zinc, that is mixed with liquid elemental mercury for the direct filling of carious lesions or structural defects in teeth
Powder and liquid metals encapsulated and separated by a septum.  Forms a solid upon mixing.
Heterogeneous mixture of alloy and elemental mercury hardens to form a solid that is used as a direct filling material
Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types
This test is intended to measure the degree of similarity between the RNA expression pattern in a patient?s fresh-frozen tumor and the RNA expression patterns in a database of tumor samples for some common malignant tumor types that were diagno
Gene expression systems, which include either microarray systems or reverse-transcriptase polymerase chain reaction (RT-PCR) systems.  Steps for microarray systems include RNA isolation kits, cDNA synthesis kits, in vitro transcription kits, hy
Uses Gene expression and computer algorithm that estimate degree of similarity between analyzed specimen and examples of various tumor types comprising a database.  Gene expression involves isolation of RNA from frozen tumor tissue sections, am
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
Indicated for:  1.	Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.  2.	Correction of varus, valgus, or posttraumatic deformity.  3.	Correction
May include:    Femoral Component  Tibial Component  Metal Backed Patellar Component  Tibial Insert  Patella Insert  All Poly Patellar Component  Instrumentation
This device is intended to be implanted to replace a knee joint.  The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces.  It has no linkage across the joint.  This generic type of device
Foot Examination Tool For Inflammatory Changes
Assist a patient to visualize the image and condition of the soles of their feet in connection with a daily self-examination for signs of inflammation on the sole of the foot.  The device will assist the patient in determining when they should
A device that consists of a 2X convex mirror, surrounded on two sides by liquid  crystal pads. These liquid crystal pads react to skin temperature when the patient places his  feet on top of them, providing different colors for different temper
Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate
Maintain position of bone graft in spinal fusion procedures. Intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts, in conjunction with traditional rigid f
Plates and screws made from resorbable materials such polylactic acid
Attaches to anterior column of spine using screws
anterior column of lumbar or cervical spine
Right Ventricular Bypass (Assist) Device
To provide circulatory support for patients in cardiogenic shock due to acute right ventricular failure.
The system is comprised of a blood pump, motor, drive console, flow sensor, and inlet and outlet cannulae.  The blood pump is single-use only but the other components can be reused.
The blood pump is driven by a motor and controller, to propel blood from the right ventricle or atrium to the pulmonary circulation.
right ventricle or atrium to pulmonary circulation
Resorbable Spinal Intervertebral Body Fixation Orthosis - Mesh
Meshes and screws made from resorbable materials such polylactic acid
Anterior column of lumbar or cervical spine
Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test
For the detection of effector T cells that respond to stimulation by Mycobacterium tuberculosis antigens ESAT-6 and CFP-10 and indicated for use as an aid in the diagnosis of M. tuberculosis infection in conjunction with risk assesment, radiogr
Enzyme Linked Immunosorbent Assay For The Detection Of Lipoarabinomannan Antigen Of Mycobacteria
Enzyme linked immunosorbent assay (elisa) system intended for in vitro diagnostic use to qualitatively detect the presence of lipoarabinomannan (lam) antigen of mycobacteria in human urine as an aid in the diagnosis of current mycobacterial inf
Orthopedic Computer Controlled Surgical System
Pre-operative planning and intra-operative execution of surgical movements with robotically controlled end effectors under user supervision.  Alternative to manual planning and broaching/reaming techniques for femoral canal preparation in prima
Preoperative Planning Workstation, a robotic arm, electronics control cabinet, display monitor and miscellaneous accessories (such as cutters, drapes, irrigation sets, probes and markers).
The system registers patient anatomy to a pre-operative surgical plan to guide a robotic arm during the milling of the femeral canal for primary total hip arthroplasty.
Cardiac Allograft Gene Expression Profiling Test System
In vitro diagnostic multivariate index assay (ivdmia) test service, performed in a single laboratory, for assessing the gene expression profile of rna isolated from peripheral blood mononuclear cells (pbmc) and indicated for use to aid in the i
quantitative real-time polymerase chain reaction technology (qRT-PCR)
Vacuum Powered Body Fluid Collection Kit
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
Drug eluting permanent lv pacemaker electrodes are used with compatible cardiac rhythm therapy (crt) devices to deliver pacing pulses to the heart.
The device is a flexible, insulated electrical conductor with one end designed to make a secure connection to a CRT device and the other end located in a left cardiac vein.
Used as part of an implantable crt system.
Makes contact with the lv via the left cardiac vein.
Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction - Hde
Device type:  Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction, revision spine surgery, autograft not available or feasible - replacement for autograft bone in patients where autograft is unavailable or no
Product provides signal for cell differentiation and scaffold for new bone growth
Access to central venous system for blood sampling and infusion, and to provide a means to secure the catheter via a subcutaneous anchor below the insertion site.
Central venous catheter with subcutaneous securement system.
Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction - Hde, Long Bone Nonunion
Bone graft substitute when autograft is unavailable or unfeasible to harvest for treatment of recalcitrant long bone non-unions where normal bone metabolism and healing is not present, e.g., smokers and diabetics.
protein solution-soaked colagen sponge or putty containing collagen and protein
used as a substitute for autograft when autograft harvesting is nt possible or not feasible
Light Based Treatment For Cold Sores Herpes Simplex Virus-1
Shortens the time to healing as compared to untreated cold sores.  This is a treatment of individual herpes labialis lesions in persons infected with the herpes simplex virus.
Uses a 1072nm +/- 12nm peak wavelength on a cold sore for a period of approximately 3 minutes. The power source is a standard alkaline 9v battery, which is replaceable. Treatment with the cold sore machine is commenced at the first symptoms of
Applies low level light to a herpes simplex virus cold sore on the lips. The light shortens the healing time of the cold sore.
Intravascular Administration Set, Automated Air Removal System
An intravascular administration set, automated air removal system is a prescription device used to detect and automatically remove air from an intravascular administration set with minimal to no interruption in the flow of the IV fluid.
The device may include an air identification mechanism, software, an air removal mechanism, tubing, apparatus to collect removed air and safety control mechanisms to address hazardous situations. Once air is identified, the device air removal m
The device is intended for intravenous infusion systems.
For the detection of anti-outer membrane protein (anti-OMP) antibodies in human serum.  To aid in the diagnosis of Crohn's Disease.
Comprised of antigen coated microtiter plate, enzyme conjugate, substrate, controls
Uses enzyme-linked, immunosorbent assay (ELISA) to identify the presence of anti-OMP antibodies.
Hyperthermia System, Bladder Cancer Treatment, With Chemotherapy
To heat the bladder wall concomitant with intravesical instillation of a chemotherapy drug.  For the prophylactic treatment of bladder cancer recurrence following standard resection of tumors.
A hyperthermia control unit, a transurethral treatment catheter, and connecting tubing/cables.
Uses RF/microwave energy to heat the bladder wall and the intravesical chemotherapy solution.
Negative Pressure Wound Therapy Non-Powered Suction Apparatus
A non-powered suction apparatus indicated for negative pressure wound therapy (npwt) that is intended for wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudat
The wound bed is dressed, fitted with mode of communication between the wound bed and suction apparatus, and sealed (according to labeling instructions).  The suction apparatus is engaged to create a vacuum (negative pressure) within the wound
For management of chronic, acute, traumatic, subacute and dehisced wounds; partial-thickness burns; ulcers (such as diabetic or pressure) flaps and grafts.
Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache
Transcranial magnetic stimulator for the treatment of migraine headache delivers brief duration, rapidly alternating, or pulsed, magnetic fields that are externally directed at spatially discrete regions of the brain to induce electric currents
The device includes a magnetic coil, power modules, software, and user interface.
Delivers brief duration, rapidly alternating, or pulsed, magnetic fields that are externally directed at spatially discrete regions of the brain to induce electric currents in the brain.
A ventricular bypass (assist) device is a device that assists the left or right ventricle in maintaining circulatory blood flow  for <6 hours. The device is either totally or partially implanted in the body.
A ventricular bypass (assist) device is a device that assists the left or right ventricle in maintaining circulatory blood flow for < 6 hours. The device is either totally or partially implanted in the body.
Lacrimal stents and intubations sets are intended to repair the lacrimal drainage system.  Lacrimal stents and intubations sets are indicated for, but limited to, the treatment of epiphora in infants and adults; canalicular pathologies such as
A stent is a small tube generally made of silicone that is placed at the point of constriction to open it up. The intubation set is composed of a balloon and catheter composed of silicone.
The nasal punctum is probed with a fine stainless steel probe to determine the patency of the opening and adjoining lacrimal duct. This procedure is known as dilation and then maybe followed by sterile saline irrigation to test for lower patenc
These devices are restricted to the nasal punctum and lacrimal ducts of the eye.
Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen
Intended for use in surgical procedures for the repair and reinforcement of soft tissue injuries of the medial meniscus.  In repairing and reinforcing medial meniscal defects, the patient must have an intact meniscal rim and anterior and poster
The device is provided in one configuration: a semi-lunar shape with a triangular cross-section for use in the medial meniscus.  The device is a resorbable collagen matrix composed primarily of bovine Type I collagen (~99%) derived from Achille
The device is a partially resorbable scaffold intended for the repair and reinforcement of soft tissue injuries of the medial meniscus.  For proper implantation of the device, a partial meniscectomy is performed and necessary tissue is removed
Internal  Polymerase Chain Reaction  Control, Not Assay Specific
Internal control that can be used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays.  It is not intended to monit
It is a nonsense, non-specific deoxyribonucleic acid (DNA) sequence cloned into a plasmid vector and supplied in a tris ethylenediaminetetraacetic acid buffer.
The internal control template is a synthetic deoxyribonucleic acid (DNA) sequence that can be added to samples prior to nucleic acid extraction.  With the addition of specific primer and probe sets, it is then amplified along with the target DN
A MEDEVAC oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve) to be used exclusively aboard a MEDEVAC helicopter and affixed
oxygen concentrator, tubing, monitors and gauges, oxygen tank. This classification is only for oxygen generators that are used on MEDEVAC helicopters and are permanently affixed to the helicopter.  For general use oxygen generators use product
This device uses a molecular sieve (for example zeolite) or other means to concentrate oxygen for medical use. For general use portable oxygen generators, use product code CAW.
This device is intended to provide oxygen for patients.
To measure testicular volume to diagnose abnormalities, or to determine the size of testicular prosthesis to implant.
The orchidometer consists of a set of oval beads of various known volumes.
To the patients testes to oval beads of known volume.
The orchidometer is held next to the patient's scrotum.
Non-invasive reduction in fat layer for body contouring
laser system that emits laser energy in the red spectrum
use of low level laser energy to create pores in adipocyte cells to release lipoproteins
adipocyte cells within the fat layer of the body, this could include wasit, thighs, abdomin, hips, etc...
To approximate soft tissues by means of absorbable staples delivered via a pre-loaded stapler delivery system for use during nasal septal surgery, with or without cartilage reinserted.  To connect internal nasal tissues to aid healing during na
Resorbable polymer (e.g., poly(L-lactide-co-glycolide) with a size of approximately 5 mm X 2.5 mm X 0.5 mm thick.
Resorbable fixation devices are delivered via a pre-loaded manual surgical stapler delivery system.
Deep Brain Stimulator For Obsessive Compulsive Disorder (Ocd)
The device is indicated for bilateral stimulation of the anterior limb of the internal capsule, this device is indicated as an adjunct to medications and as an alternative to anterior capsulotomy for treatment of chronic, severe, treatment-resi
Anterior limb of the internal capsule in the brain
Stereotaxic guidance during orthopedic surgery procedures.  Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.
Device consists of Camera, computer, various shaped tracking arrays, computer interface for commmunication between user and device.
User loads Computer software pre-Op to plan surgery procedure, then registers the patient anatomy during surgery to allow software to track patient anatomy, implants, and surgical tools in real time/space.
Orthopedic joints and spinal procedures where tracking of instrumentation is desired.
Over-The-Counter Powered Light Based Laser For Acne
The device is intended for over-the-counter (otc) use to treat patients with mild to moderate acne vulgaris.  The device is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acn
The outputs are pre-tuned to a particular wavelength with a narrow spectral bandwidth.
Mainly on the face, but can be on the back or on the other parts of the body. Treatment area is 5x6 cm (at a time.)
Intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief.  Unclassified status per SE to MGQ.
Supplied as an oral rinse or as a gel, liquid or patch to be directly applied to an oral wound
Oral Wound Dressing W/Drug And/Or Biologic
Intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief.  Unclassified status per se to mgq.
Supplied as an oral rinse or as a gel, liquid or patch to be directly applied to an oral wound.
Analyze electroencephalograph data using conventional methodology to output and display standard electroencephalograph parameters for interpretation by a qualified user.
Electroencephalograph analysis software.  Does NOT include electrodes, amplitude-integrated electroencephalograph, automatic event-detection software, software that compares data to a database (normal or otherwise) or electroencephalograph soft
Uses software algorithms as a tool to analyze electroencephalograph (from user-specified electrode number and locations) and automatically calculate conventional electroencephalograph parameters. (e.g. spectral edge frequency, total power, perc
Post-hoc statistical analysis of electroencephalograph signals with comparison to a normative database for interpretation by a qualified user.
Electroencephalograph analysis software.  Does NOT include electrodes, amplitude-integrated electroencephalograph, automatic event-detection software,  software that compares data to non-normative databases, software that does not compare to a
Uses software algorithms as a tool to analyze electroencephalograph (from user-specified electrode number and locations) and automatically calculates conventional electroencephalograph parameters. (e.g. power, asymmetry, coherence) and normaliz
Acquire, display, store, and archive electroencephalographic signals from the brain and other signals (such as electromyography, respiratory and/or oximetry signals) for sleep recordings.  May also be used to allow on-screen review, user-contro
May include standard polysomnography recording hardware (e.g. headbox, cables, computer, monitor, wireless) and basic software (e.g. used to display, store, archive, or manually annotate data).  Does NOT include electrodes, vital signs monitors
Uses electrodes placed on the scalp, within the brain, or other locations, via user-specified locations, to record and display electrical activity of the brain and other organs
Analyze electrical activity of the brain by transformation of electroencephalograph signals into a dimensionless index number for use and interpretation by a qualified user.
Electroencephalograph analysis software, either developed by 510(k) holder for use in their own hardware or licensed from another company for use in 510(k) holder's hardware.  Does NOT include electrodes, amplitude-integrated electroencephalogr
Uses software algorithms, developed from and trained with specific patient datasets, to analyze electroencephalograph from 1 to 16 electrodes at sponsor-specified locations; also may output one or several signal quality indicators
Source Localization Software For Electroencephalograph Or Magnetoencephalograph
Correlation of electrical activity of the brain using various neuroimaging modalities for source-localization
Software algorithm.  Does NOT include electrodes, amplitude-integrated electroencephalograph, automatic event-detection software used as the only or final electroencephalograph analysis step, electroencephalograph software with comparative data
Uses software algorithms that correlate the electroencephalograph to one or several types of neuroimaging data.  May include use of event-detection algorithms (that require user confirmation) as an intermediary, but not final, step.
Acquire, display, store, and archive biomagnetic signals produced by electrically active nerve tissue in the brain to provide information about the location of active nerve tissue responsible for certain brain functions relative to brain anatom
Magnetoencephalograph recording device (hardware, basic software)
Uses a helmet with sensors to record the magnetic activity of the brain
Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Automatically mark electroencephalograph and polysomongraph signals in order to aid in identification of such events and annotation of prolonged PSG traces; Automatically calculate simple measures obtained from recorded signals (e.G. Magnitude,
Electroencephalograph analysis software.  Does NOT include electrodes, electroencephalograph hardware, polysomnograph hardware, or basic electroencephalograph/polysomnograph software (e.g. used to display, store, archive, or manually annotate d
Uses software algorithms to analyze electroencephalograph and polysomnograph waveforms and automatically identify areas of interest to the user
Measure and record electrical activity of the brain by acquisition of amplitude-integrated electroencephalograph (electroencephalograph signals that have been filtered and displayed in a specific manner).
Uses a specific combination of filters, a semi-logarithmic scale and bipolar electrode placements (via user-specified  and/or sponsor-specified locations), to record and display electrical activity of the brain.
Automatic Event Detection Software For Full-Montage Electroencephalograph
Automatically mark or identify electroencephalograph waveforms for spikes, electrographic seizures, seizure-like events in order to aid in identification of such events and help review and annotation of prolonged EEG traces; All output subject
Electroencephalograph analysis software.  Does NOT include electrodes, electroencephalograph hardware, basic electroencephalograph software (e.g. used to display, store, archive, or manually annotate data),  or automatic event detection softwar
Uses software algorithms to analyze full-montage electroencephalograph (16 electrodes) at user-specified locations and automatically identify areas of interest.
Acquire, display, store, and archive electroencephalographic signals from the brain using a user-specified and/or sponsor-specified locations with a reduced array (i.e. less than < 16) of electrodes
May include standard EEG recording hardware (e.g. headbox, cables, CPU, monitor and basic software (needed to display, store and archive EEG and allow user-only annotation and marking); does NOT include electrodes, more complex software used to
Uses electrodes (less than < 16) placed on the scalp or within the brain, via user-specified  and/or sponsor-specified locations, to record and display electrical activity of the brain
For topical application only to hold closed easily approximated skin edges of wounds such as wounds from surgical incisions, including punctures from minimally invasive surgery, and simple thorough cleansed, trauma-induced lacerations.  The dev
1) A liquid adhesive and  2) A self-adhering initiated mesh athat is packaged within an applicator
Adhesive to hold closed skin edges of wounds
The device is meant to act topically on the skin
For use for extracorporeal shock wave treatment of atrophic nonunion fractures.  The device delivers a shock wave to the patient via a water-filled coupling membrane whic is intented to help atrophic nonunion fractures heal.
Length of arm 600/700mm, Reflecture aperture: 620-1010mm, weight: 152 kg
The device delivers a shock wave to the patient via a water-filled coupling membrane whic is intented to help atrophic nonunion fractures heal.
Bone that has an atrophic nonunion fracture
Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position
When used in connection with a locator instrument is designed to aid in the placement of central venous catheters by providing real-time information as to the position of the catheter inside the body during the catheter insertion procedure.
device is placed inside a central venous catheter
It is intended for the qualitative detection and identification of human metapneumovirus (hMPV) in direct respiratory specimens or cell culture. The assay detects hMPV antigens by immunofluorescence using antibodies, from patients with signs an
The assay detects hMPV antigens by immunofluorescence using antibodies.
Direct clinical speciemns or cell culture amplified speciemns
Pericardial Patch To Facilitate Revision Surgeries
Pericardial patch or pledget with the secondary function of facilitating revision surgeries by providing a plane of dissection.  Does not include devices whose primary purpose is to minimize the incidence or severity of adhesion formation as a
Multiplex Flow Immunoassay, T.Gondii, Rubella And Cmv.
The kit is a multiplex immunoassay intended for the quantitative detection of IgG antibodies to Toxoplasma gondii (T. gondii) and Rubella, and  qualitative detection of Cytomegalovirus (CMV) IgG in human serum and/ or plasma.  Indicated as an a
The device is a fully automated instrument.
The device utilizes multiplex immunofluorescence technology to assess the presence of IgG antibodies for each of the analytes in the panel in a single sample by binding to antigen-coated fluoromagnetic beads with unique fluorescent signatures.
Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr
In vitro diagnostic for the detection and genotyping of a single point mutation of the human 5, 10-methylenetetrahydrofolate reductase gene (MTHFR) in patients with suspected thrombophilia.
Uses DNA genotyping technology to determine patient genotype at the 5, 10-methylenetetrahydrofolate reductase gene locus.
C. Difficile Nucleic Acid Amplification Test Assay
In vitro diagnostic test for the qualitative detection of toxigenic clostridium difficile nucleic acids isolated and purified from stool specimens obtained from symptomatic patients.
kIt containing DNA positive control, DNA internal control, buffer containing deoxyribonucleic acids and magnesium chloride, DNA polymerase, DNA primers and DNA probes
Negative Pressure Wound Therapy Powered Suction Pump
For wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials.  The Device is indicated for management of chronic, ac
Powered suction pump and wound dressing kit
The wound bed is dressed, fitted with mode of communication between the wound bed and suction apparatus, and sealed (according to labeling instructions). The suction apparatus is engaged to create a vacuum (negative pressure) within the wound b
For management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
These device types do not include devices whose primary purpose is to minimize the incidence or severity of adhesion formation as a result of vascular surgery.  Intended to protect vessels from injury during surgery (not to be confused with wra
The material is cut to size, then laid over a blood vessel and sutured/tacked into nearby tissue to keep it from migrating
over a blood vessel, typically the aorta during anterior vertebral surgery
Novel Influenza A Virus, A/H5 Ns1 Protein
Novel influenza A virus reagents are used to directly detect and differentiate novel influenza A virus specific nonstructural protein 1 (NS1) in human respiratory specimens or viral cultures.  Detection and differentiation of specific NS1 prote
Immunoassay using PDZ domains in intracellular receptors to capture influenza A/H5 NS1 protein
A pre-formed (polymerized) absorbable lung biopsy plug is intended to provide accuracy in marking a biopsy location for visualization during surgical resection and closure of pleural punctures associated with percutaneous, transthoracic needle
Polymerized hydrogel plug, cylindrical in shape and placed by a deployment system following lung biopsy by smaller biopsy needle/instrument.
Upon deployment into a lung biopsy tract, the plug expands to fill the biopsy void provide closure of the biopsy void.
to be used in the lung, specifically in punctures left by percutenous, transthoracic needles
Intended to measure thickness of a distinctive tissue layer.  Indicated to Calculate the local thickness of a type of tissue [fat, muscle, bone, etc.] at a single location, or at various locations  on the body and via algorithms, estimate the a
Hand-held cylindrical (or other shaped) electro/mechanical software-controlled device made of plastic and/or metal components and crystalline transducers.
Sends ultrasonic radiation produced by a piezoelectric crystal transmitter/transducer through body tissue at the site chosen and measures the speed of reflection at a piezoelectric receiver/transducer.
Any external location on the skin or designated locations on the arm, leg, abdomen, chest, etc. that are required to validate the body composition algorithm used.
High Demand, Revision, Semi-Constrained, Pyrolytic Carbon, Uncemented Finger Prosthesis
For use in arthroplasty of the proximal interphalangeal (PIP) joint when the patient: a) has soft tissue and bone that can provide adequate stabilization and fixation under high-demand loading conditions after reconstruction; and b) needs a rev
Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter
Catheter is used for Percutaneous Transluminal or balloon Valvuloplasty (PTV) of the pulmonary (pulmonic) valve.  Used on patients with isolated pulmonary stenosis and also on patients with valvular pulmonary stenosis with other minor congenita
The device is a catheter with a balloon tip.
Catheter contains a ballon at the distal end of the shaft.  The catheter is inserted into the body and directed towards the pulmonary valve.  Once the catheter is placed in the valve, the balloon is expanded which compresses and/or breaks the m
The target area is the pulmonary valve of the heart.
Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Reconstitute and transfer antineoplastic and other hazardous drugs in healthcare setting indicated to reduce exposure of healthcare personnel to chemotherapy agents in healthcare setting.
Vial adator with piercing spikes, contain Luer-Lock connector fitted with elastomeric membrane to provide a sealed connection between syringe, I.V. administration set or tranfer bag. May contain side pressure-equalizing protector unit. May cont
Placed over vial or container containing the chemotheraphy drug
Device is not act on any part of body. I.V. infusion devices, catheters, drug container closure system.
To measure the osmolality of human tears to aid in the diagnosis of patients with signs or symptoms of dry eye disease, in conjunction with other methods of clinical evaluation.
Tear collection method and impendance measuring device.
Electrical impedance measurement to provide an indirect assessment of osmolality.
Powered Light Based Non-Laser Surgical Instrument
A light based Non-Laser device typically indicated to be used for general surgical purpose in medical specialties of general and plastic surgery, dermatology/aesthetic, podiatry, otolaryngology (ENT), gynecology, neurosurgery, orthopedics (soft
The device comes in a wide verity of shapes and sizes. It could be hand held and with weight less than one pound or it could be heavy with weight more than fifty pounds. It generally has a base station with attachments such as different hand pi
This is a powered light based but non-laser instrument that uses light energy to destroy or coagulate tissue, generally soft tissue.
The device generally targets skin (including dermis, epidermis) and underlying soft tissue or soft tissue in general.
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
A light based non-laser device that provides thermal effect including broad spectrum source devices such as intense pulse light (ipl). Typically, indicated to be used in medical specialties of general and plastic surgery and of dermatology/aest
This is a light based Non-Laser device that provides thermal effect including broad spectrum source devices such as Intense Pulse Light (IPL) that uses light energy to cut, destroy, remove or coagulate tissue, generally soft tissue. The classif
Powered Laser Surgical Instrument With Microbeam\Fractional Output
A LASER (Light Amplification by Stimulated Emission of Radiation) based device having coherence, collimated and typically monochromatic radiation. The laser output is in form of tiny beams in micro range. Typically, indicated to be used in medi
A LASER (Light Amplification by Stimulated Emission of Radiation) based device having coherence, collimated and typically monochromatic radiation. The laser output is in form of tiny beam(s) in micro range. The classification regulation 21 CFR
Dissolvable Gel For Preventing Ureteral Stone Migration
For use in the ureter to prevent the migration of urinary calculi and their fragments during intracorporeal lithotripsy procedures.
The device is an injectable gel that is capable of being dissolved using endoscopic irrigation.
The gel temporarily obstructs the ureter to limit the migration of urinary calculi and their fragments during intracorporeal lithotripsy procedures.  After the lithotripsy procedure, the gel is dissolved using irrigation.
An oral lubricant  to be used adjacent to hard and soft tissue and the lips to prevent adherence of dental cement; Placement of a rubber dam; And to prevent the lips from drying and cracking during dental procedures.
The device is intended to provide an enclosure for storage of an radiant infant warmer. It may also provide a bassinet for use with the radiant infant warmer, and provide power to the infant radiant warmer.
The accessory could be in a range of sizs and materials. The important aspects are its capability of providing suppport as a bassinet and electrical safety.
When not in use, the device encloses the infant radiant warmer. The device opens to provide a bassinet placed under the warmer. The device includes a power outlet that provides power to the warmer and includes a cut-off switch to disconnect pow
The accessory is intended for use with an infant radiant warmer, which are intended for use in warming the whole body of an infant.
Intraoperative Orthopedic Joint Assessment Aid
Measurement and interpretation of orthopedic joint information.
Measurement transducer, central processing unit, and user interface.
The system analytically measures the joint state and interprets the measurements using a software algorithm to aid in the positioning of an implant system.
Neurosurgical Laser With Mr Thermography
Laser device for use to necrotize or coagulate soft tissue through interstitial irradition or thermal therapy under mri guidance and real time mr thermography in neurosurgery.
Laser system under MRI guidance and MR thermography
Laser energy to necrotize or coagulate brain tissue.
For the treatment of spider vein or telangiectasia by thermocoagulation.
Electrosurgical generator and needle electrodes
N95 Respirator With Antimicrobial/Antiviral Agent
A single use, disposable, NIOSH-approved respirator intended for occupational use to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological particulates and has an added antimicrobial and/or antiviral age
The device is an N95 respirator composed of at least 3 layers of filtration material with bands or ties to secure it to the head, a flexible noseband to insure a close fit and an added, specified antimicrobial and/or antiviral agent added to th
Device uses a combination of tight facial fit and filtration to help reduce exposure to particulate aerosols plus the addition of an antimicrobial and/or antiviral agent which kills specified pathogens under specified contact conditions
The device is worn over the nose and mouth  and is intended to protect the respiratory tract from hazardous particulates
Drug-Eluting Peripheral Transluminal Angioplasty Catheter
A drug-eluting peripheral transluminal angioplasty catheter is a combination product intended for balloon dilatation of peripheral vasculature to establish or maintain patency. A drug-eluting PTA catheter delivers a drug to the vessel as part o
The balloon catheter is generally constructed of synthetic materials such as plastic and introduced into the body using a guidewire.  The balloon is generally manufactured in multiple diameters and lengths to allow for treatment of different le
The balloon catheter uses mechanical force across a lesion to establish patency.  The drug coating serves as an adjunct to the mechanical action of balloon angioplasty and assists in maintaining vessel patency post-procedure.
Lesions in peripheral arteries including iliac, popliteal, infrapopliteal,   femoral, and iliofemoral
It is indicated for use on cutaneous lesions with one or more clinical or historical characteristics of melanoma, when a dermatologist chooses to obtain additional information when considering biopsy. It should not be used on clinically obvious
Device is comprised of 1) Control Unit:  processes examination data and presents electrical impedance spectra on the display, includes touch screen for user interaction, 2) Probe:  holds the electrode used for lesion evaluation, 3)Probe Cable:
It utilizes electric impedance to characterize skin tissue in real-time. It consists of a control unit and a disposable electrode.
To treat and provide hemodialysis therapy at home for chronic renal failure patients.
Complex machine consisting of pumps, monitors, and tubing.
A machine that dialyzes the patient's blood.
Ovarian Adnexal Mass Assessment Score Test System
An ovarian/adnexal mass assessment test is a devicem that measures one or more proteins in serum.  It yields a single result for the likelihood that an adnexal pelvic mass in a woman, for whom surgery is planned, is malignant.  The test isn for
Oral Removable Retainer For Weight Management
A removable oral device used during meals to limit food intake.
Stainless steel wire, electrical sensor and palatal mold (polymer)
This device is a volume assist ventilator intended to aid adult patients with respiratory insufficiency. It is designed for patients who are capable  of spontaneously breathing a minimum tidal volume of 3.5cc/kg of predicted body weight. The de
A small, wearable ventilator that interfaces with proprietary nasal and  tracheostomy patient interfaces.
The device  consists of two components: a ventilator and a patient interface. The device is a light-weight, portable, electronically timed and controlled volume assist ventilator.   The device delivers 100% oxygen in volumes of 50-250ml. The de
The device delivers augmented volumes of 100% oxygen into the patient's airway.
Provides a counter-pressure to the anus during vaginal delivery.  Intended to prevent the occurrence of and/or stop the progression of hemorrhoids associated with vaginal delivery.
Items include: rigid base with cushioning pad and two lateral straps and two adhesive pads that are applied to the buttocks
Uses a rigid base with cushioning pad applied to the anus held in place by two adhesive strips attached to the buttocks, to provide a counter-pressure to the anus during vaginal delivery
To be implanted to reinforce soft tissue or bone where weakness exists. Intended to be used wherever temporary wound support is required, to reinforce soft tissues where weakness exists in the urological, gynecological, or gastrointestinal anat
absorbable solid form of poly(hydroxybutyrate)
material is isolated from prokaryotic cells produced by recombinant deoxyribonucleic acid (DNA) methods
Precise cutting or ablation of ocular tissue, indicated for the anterior capsulotomy during cataract surgery.
The device consists of a laser console, a computer with grahic user interface, a beam delivery system that positions and focuses the laser beam, and a patient interface system that flattens the cornea and holds the patient's eye still during th
A Nd:glass solid state laser generates sub-picosecond pulses at a 15 kHz repetition rate.  The beam is focused at high convergence to a spot diameter <6 microns at the target location.  Tissue is vaporized in a very small region at the focal po
Intended as a final container for the cryopreservation and the storage of cord blood products.  A cryogenic cord blood storage container is a flexible ethylene vinyl acetate (eva) or similar polymer bag intended as a final container for cryopre
Consists of flexible ethylene vinyl acetate (EVA) or similar polymer bag.  May include sterile fluid path and access ports and is designed to withstand freezing in the liquid and vapor phases of liquid nitrogen.
Acts as a physical container for cord blood products, and is designed to withstand freezing in the liquid and vapor phases of liquid nitrogen
Cord blood is collected from neonatal umbilical cord and stored for later infusion, injection or transplantation
Intended to be used to assist in the implantation of a specific knee arthroplasty device or a set of specific knee arthroplasty devices.  Indicated to include guiding alignment, making or establishing cuts, selecting, sizing, attaching, positio
A device accessory or set of device accessories;
Aids the surgeon in performing the implantation of the knee implant
Real Time Nucleic Acid Amplification System
The system is a clinical multiplex instrument intended to measure and sort multiple signals generated my multiple probes, intercalating dyes, or other ligands in an assay from a clinical sample. Signals may be generated by fluorescence or other
Should not include microarray or electrophoresis detection methods or instruments.
A real-time thermocycler is intended to identify and/or quantify the presence of specific sequences of double stranded DNA, amplified from a biological source and labeled with fluorescently labeled probes or through the use of intercalating dye
The device is a combination of a cooling pad associated with a vacuum or mechanical massager intended for the disrutpion or induction of adipocyte cells indicated for body contouring or reduction in circumferance of body areas.
the device is a combination of a cooling pad associated with a vacuum or mechanical massager intended for the disrutpion or induction of adipocyte cells indicated for body contouring or reduction in circumferance of body areas.
release of fat and lipids from adipocyte cells resulting in reduction in fat layer
areasof the body for which a subject wishes to have reduction in size such as abdomen, thighs, waist, hips.
For measuring the depth of a passageway in bone or tissue, prior to insertion of screws or other hardware.  The device is an electronic depth gauge for various medical purposes including, measuring the depth of a passageway in a bone or other t
May have components of metal and plastic, and includes a battery or power source, an LCD or other display, and software and/or firmware
Uses a mechanical sliding probe, in conjunction with hardware that creates a variable voltage input based on probe position and software, to display digitally a measured depth
Bone or tissue sites where tunnels or steps exist, or drilling or cutting has occurred
Parainfluenza Multiplex Nucleic Acid Assay
A parainfluenza multiplex nucleic acid assay is a multiplex in vitro diagnostic test for the simultaneous qualitative detection and discrimination of parainfluenza 1 virus, parainfluenza 2 virus, parainfluenza 3 virus and parainfluenza 4 virus
Intended for use in the insertion of suppositories into the rectum
plastic, non-sterile, single use plunger movably coupled with a barrel.
The automated test system is intended for the qualitative detection of fecal occult blood in feces by professional laboratories.  The automated test is used for the determination of gastrointestinal bleeding.
The system consists of an analyzer, test reagents (antibody, calibrators and controls) and collection devices containing buffer.
The test reagent contains an immunoassay utilizing monoclonal and polyclonal antibodies for human hemoglobin.  A light beam measures the antibody reaction, i.e. the absorbance fo the reaction mixture measures the concentration of hemoglobin in
Bronchial thermoplasty systems are intended for the treatment of severe persistent asthma in patients whose asthma is not well controlled with inhaled corticosteroids and long acting beta agonists to reduce the effects of their asthma by using
Bronchial thermoplasty systems are composed of a catheter with an electrode that delivers radiofrequency (RF) energy to the airways, as well as an controller unit that generates RF energy and controls the parameters of delivery.
Bronchial thermoplasty systems use radiofrequency (RF) energy to ablate smooth muscle tissue in the airways.
Bronchial thermoplasty systems target the airways of the lung and the smooth muscle that lines the airway lumen.
Powder-Free Non-Natural Rubber Latex Surgeon'S Gloves
A powder-free surgeon's glove is a disposable device made of non-natural rubber that may bear a trace amount of residual powder and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially i
Powder-Free Polychloroprene Patient Examination Glove
A powder free polychloroprene patient examination glove is a disposable device made of polychloroprene rubber tthat bears powder to facilitate donning, and is intended to be worn on the hand for medical purposes to provide a barrier against pot
Radiations attenuating medical gloves are medical gloves that are used during medical or surgical procedures involving radiation to shield the hands of the wearer from scattered radiation exposure. The gloves offer some degree of protection to
A disposable  medical glove (examination or surgeons)  that is worn on the examiner's hand to prevent contamination between patient and examiner and to serve the indicated use of the added antimicrobial agent which may vary with the added antim
Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
A disposable medical glove (examination or surgeons) that is worn on the examiner's hand to prevent contamination between patient and examiner.  In addition, these gloves have been tested for permeation and breakthrough resistance against vario
Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus
The test is a multiplex immunoassay intended for the qualitative detection of specific human IgG antibodies to measles virus, mumps virus, Rubella and varicella zoster virus (VZV) in human serum and/ or plasma. The results of this assay are int
The device is a fully automated instrument
Multiplex flow immunoassay (multiplexed fluromagnetic bead assay)
The device is an in-vitro diagnostic device; none of the body parts will utilize the device or is intended to be affected by the device
Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2
The test is a multiplex immunoassay intended for the qualitative detection of specific human IgG antibodies to Toxoplasma gondii (T.gondii), Rubella, Cytomegalovirus (CMV) and Herpes Simplex Virus 1 & 2 (HSV 1 and HSV 2) in human serum. The res
Auto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex
For the detection of autoantibodies to phosphatidylserine (PS), prothrombin (PT), or phosphatidylserine/prothrombin (PS/PT) complex in human serum or plasma.  To aid in the diagnosis of certain autoimmune thrombotic disorders such as anti-phosp
Microtiter plate coated with purified antigen, enzyme labelled anti-human antibody substrate
The device is adhered to the body for several days for the purpose of periodically infusing an insulin bolus.
The device is worn directly on the body. It is constructed of a variety of polymeric materials. Stainless steel is used in springs.
The device contains the insulin in a reservoir attached to a pumping mechanism. The pump delivers a discrete bolus volume to the patient on demand. There are no means of providing continuous infusion.
Subcutaneous tissue. The device is generally targeted for use on the abdomen, buttocks, or other location acceptable for insulin delivery and device placement.
To employ near-infrared spectroscopy that is intended to be used to evaluate suspected brain hematomas.
This is a standard infrared handheld laser that is scanned across the scalp.  The information is transmitted to a handheld Personal Digital Assistant that displays Optical Density measurements
Use of low level infrared laser radiation to detect hemoglobin concentration which relates to presence of a hemotoma.
To be used on the head.  The testing divides the head into 8 sections four on the left side and the corresponding 4 sites on the right side.
Reagents, 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification
2009 H1N1 influenza virus detection and identification reagents are used to directly detect and differentiate the 2009 H1N1 influenza virus in human respiratory specimens.
Nucleic acid amplification or antigen detection assays
The device is an in-vitro diagnostic device; none of the body parts will utilize the device or are intended to be affected by the device.
Immunoglobulin A Kappa Heavy & Light Chain Combined
Intended for the in-vitro quantification of iga kappa concentration in human serum.  The result is to be used with previously diagnosed iga multiple myeloma, in conjunction with other clinical and laboratory findings.  For previously diagnosed
Kit is composed of polyclonal monospecific sheep anti-IgA Kappa antibody, IgA Kappa calibrator, 2 IgA Kappa Controls, and IgA Kappa Supplementary Reagent
Intended for the in-vitro quantification of  iga lambda  concentration  in human serum. The result is to be used with previously diagnosed iga multiple myeloma, in conjunction with other clinical and laboratory findings. For previously diagnose
The kit is composed of polyclonal monospecific sheep Anti-IgA Lambda antibody, IgA Lambda Calibrator, 2 IgA Lambda Controls, and IgA Lambda Supplementary Reagent
Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.  2. Rheumatoid arthritis.  3. Correction of functional deformity.  4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of t
May include:    Acetabular Shell  Acetabular Liner  Femoral Head  Femoral Stem  Femoral Neck  Instrumentation
This device is intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has
Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented
This device is intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device incl
Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in
The device is intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of hernias.
The device is comprised of three main components: an inflatable spreading balloon, an adaptor, and an inflation unit/pump.
The device is reversibly attached to soft tissue prosthetics, such as surgical mesh, through the use of connectors, before being rolled for insertion into the body. Once located in the abdominal cavity, the device is spread at the desired locat
Herpes Simplex Virus Nucleic Acid Amplification Assay
A polymerase chain reaction (pcr)-based qualitative in vitro diagnostic test for the detection and typing of herpes simplex virus (hsv) dna using vaginal swab specimens.
Polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test for the detection and typing of herpes simplex virus (HSV) DNA
A clinical diagnostic test for use in the diagnosis of disease or other conditions that was developed by CLIA certified clinical laboratory for use in that laboratory. This product is neither an Analyte Specific Reagent nor are the components f
Produces an elasticity image of the prostate to document prostate abnormalities that were previously identified by digital rectal examination.
Cart-based system consisting of a hand-held rectal probe attached to a computer with proprietary image reconstruction software.
Uses an array of pressure sensors and image reconstruction software to create a 3-D map showing areas of relative tissue hardness or softness within the prostate.
The device is intended to assist in verifying ett tube placement, assist in detecting ett tube movement and obstruction of the tube tip
The device is comprised of a small monitor and a sterile, single use adapter.
The device uses acoustic reflection technologyto generate an audible sound signal from a speaker and two microphones that receive acoustic reflections that arise from within the ETT tube
The device is placed in-line between the ventilator circuit and the proximal end of the endotracheal tube of a patient who is connected to a ventilator.
2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification
2009 H1N1 influenza virus detection and identification reagents are used to directly detect and differentiate the 2009 H1N1 influenza virus in human respiratory specimens
The device is an in-vitro diagnostic device; none of the body parts will utilize the device or are intended to be affected by the device
Intended for single use for individual blood group determination for educational and informational purposes
Plastic card with mixing channels and monoclonal antibodies
The device is self-contained and consists of reagents and reaction areas and requires no other accessories with the exception of those used to add the blood sample to the device
Plastic/paper card, plate, slide or microtubules with blood grouping antibodies
provides temporary control or reduction of postpartum uterine bleeding
The device consists of a catheter with a balloon at the distal end.  The balloon is distended to achieve tamponade or reduction of post partum uterine bleeding.
The clinician passes the balloon through the vagina and cervix into the uterus.  Then, he/she distends the balloon and closely monitors the patient's bleeding.
For the semi-quantitative measurement of IgG class autoantibodies against mutated citrullinated vimentin (MCV) in human serum or plasma.
antigen coated microtiter wells, calibrators, controls, enzyme conjugate and substrate, buffer
Is intended for use by consumers at home as a qualitative test to identify the presence of alcohol in breast milk.
Should not include serum, plasma or urine
Intended to detect the presence of alcohol in breast milk. the test utilizes an emzymatically catalyzed reaction of ethyl alcohol in the presence of oxygen to produce hydrogen peroxide. The peroxide produced along with a dye substrate, are enzy
The sytem is intended to control the surgical environment to prevent bacterial contamination during surgical procedures.
A reusable mobile HEPA air filtration unit with a hose connecting to a disposable air delivery unit to be place at the surgical site.
The system uses an air supply hose connected to nozzle design that is to be mounted, or applied to the incision drape in close proximity to the surgical site to provide direct air flow blowing over the surgical incision site that helps reduce t
Optical Coherence Tomography, Intravascular Catheter
For intravascular visualization of the coronary vessel lumen and wall in patients who are candidates for transluminal interventional procedures.
A flexible intravascular catheter provides optical delivery and sensing of laser light to produce images of the vessel lumen and wall on its associated imaging system using optical coherence tomography technology.
Platelet And Plasma Separator For Bone Graft Handling
Preparation of autologous platelet rich plasma from a small sample of peripheral blood for mixing with bone graft to improve handling characteristics.
May include centrifuge, filters, tubes, syringes and needles
Uses centrifugal and/or filtration methods to separate the whole blood into components, after which the platelet rich plasma is withdrawn.
Blood drawn from peripheral veins, PRP applied to bony defects
for the quantitative determination of  lamotrigine in human serum or plasma on automated clinical chemistry analyzers.
For the quantitative determination of levetiracetam in human serum or plasma.
Intended to be used for laser assisted lipolysis
Laser Assisted Lipolysis is a procedure that uses laser energy to melt small volume of fat. The fat is then removed from the body by aspiration.
A small volume (up to 120cc) of localized deposits of fat per treatment such as chin or upper arm (triceps)
The T-Cell Xtend reagent is intended for use with the T-SPOT.TB test for the pre-treatment of whole blood prior to lymphocyte separation.  The reagent aids in the removal of selected white blood cells from whole blood stored at room temperature
T-Cell Xtend contains bispecific monoclonal antibodies which are directed against cell surface markers on selected white blood cells and glycophorin A on red blood cells.  The T-Cell Xtend reagent cross-links the selected white blood cells with
Intended to be used to facilitate the delivery of soft tissue prosthetics during the  laparoscopic repair of soft tissue defects (e.G. Hernia repair).
manual laparoscopic surgical instrument ;operation handle and deployment section.
intended to facilitate hernia mesh delivery and placement during laparoscopic ventral hernia repair.
Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri
To aid the surgeon in planning and conducting general stereotactic neurosurgery in an MRI suite.
Software:  aquire MR images, trajectory planning, guidance regarding alignment of targeting frame with planned trajectory, confirmation of final tool position (MR compatible tools only).  Hardware:  stereotaxic frame and accessories (e.g. vario
Device software receives real-time, intraoperative MR images of the brain target and the trajectory of the targeting frame attached to the patient's skull.  Software and MRIs are used to plan trajectory, guide alignment of frame with planned tr
Burst Suppression Detection Software For Electroencephalograph
Automatically mark or identify electroencephalograph waveforms for rhythmic patterns of burst suppression in order to aid in identification of such events and help in the review and annotation of prolonged EEG traces; software can also quantify
Electroencephalograph analysis software.  Does NOT include electrodes, electroencephalograph hardware, basic electroencephalograph software (e.g. used to display, store, archive, or manually annotate data), automatic event (i.e., seizure) detec
Uses simple, transparent software algorithms to analyze any size montage (full or reduced) for burst suppression patterns and automatically identify areas of interest or quantify pattern characteristics.
N95 Respirator With Antimicrobial/Antiviral Agent For Use By The General Public In Public Health Medical Emergencies
A single use, disposable, NIOSH-approved N95 respirator intended for use by the general public in public health medical emergencies to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological particulates a
Filtration. Antimicrobial / antiviral agent effectiveness.
Intended to be used for anterior advancement of the tongue base by means of a bone screw threaded with a suture.  It is indicated for the treatment of obstructive sleep apnea (OSA) and/or snoring.
Therapeutic application of heat and massage to the eyelids.
Comprised of two components, a single-use disposable unit made of biocompatible polycarbonate and silicone that is inserted around the patient's eyelids, and a handheld control system, which connects to the single-use disposable unit
Battery-operated, handheld device that the physician uses in an in-office procedure to control the application of warmth and massage to the eyelids. The handheld device connects to a single-use disposable unit made of biocompatible polycarbonat
Patient Specific Manual Navigation System
Intended for defining implant alignment relative to a patient's anatomy.
Manual Instrument with auxiliary software.
Pre-operative imagery is used to establish a correlation between the patient's anatomy and the instrument.
Patient Specific Manual Orthopedic Stereotaxic System
Intended for defining orthopedic acetabular implant alignment relative to a patient's anatomy.
Manual instrument and auxiliary software.
Pre-operative imagery, such as CT or radiographs, is used to establish a correlation between the patient's AP plane and the instrument's plane.
Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch
Relief / Reduction of Mosquito Bite Itch
The device is hand-held, composed of an insulated housing which contains a piezo-electric crystal and conductive elements to deliver charge to the skin, as well as a moving mechanical part to allow the intended user to generate the force to pro
Electrical charge, generated via piezo-electric crystal, delivered transcutaneously at the site of the mosquito bite. The piezo-electric crystal generates electrical charge by the application of a manual mechanical force.
Intended to be placed on the skin, at the site of a mosquito bite.
Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
Intended to stabilize the thoracolumbar spine as an adjunct to fusion using allograft and/or autograft to treat adolescent idiopathic scoliosis.
Bone screws, rods, and hooks intended to stabilize the spine as an adjunct to fusion
Acts as a spinal fusion system with autograft and/or allograft to stabilize the spine as an adjunct to fusion to treat adolescent idiopathic scoliosis
Posterior, non-cervical spinal column in adolescent patients
A bed intended for obese patients weighing 500 pounds and above.  Beds can expand from 38 to 60 inches in width.
Intended for the qualitative determination of autoantibodies against glutamate receptor (type NMDA) in human serum. Used as an aid in the diagnosis of anti-glutamate receptor (type NMDA) autoimmune encephalitis in conjunction with other laborat
Immunofluorescent assay with multiple substrates
Fecal occult blood controls (Negative and positive) are used to verify the performance of the fecal occult blood test devices.
The control solutions are in the aqueous form.
The test is based on the detection of human hemoglobin.  The negative control solution contains only buffer.  The positive control solution contains human hemoglobin at a specified concentration.  The control solution is placed in the test devi
Hearing Aid, Air Conduction With Wireless Technology
Wireless hearing aids are intended as acoustic amplification devices for hearing impaired users.
The device is worn behind-the-ear or in-the-canal with audio output into the ear supported by an ear canal mold.
A wireless air-conduction hearing aid is a wearable sound-amplifying device, intended to compensate for impaired hearing, that incorporates wireless technology in its programming or use.
Software associated with an orthopedic trauma device which is intended for the diagnosis or treatment of traumatic or reconstructive orthopedic conditions
Custom written or off the shelf software intended to be used with an orthopedic trauma device
Software operated by the manufacturer or end user intended to diagnose or treat an orthopedic condition
The uterine electromyographic monitor is intended to pick up uterine emg signals from surface electrodes placed on the maternal abdomen.  It produces a uterine activity tracing and monitors women in labor at term gestation with a singleton preg
Monitor with associated electronics and patient skin electrodes.
abdominal EMG surface electrodes that pick up electrical activity from the uterus in labor, electrical signal converted to a monitor tracing.
Pacemaker/ICD/CRT non-implanted components provide programming, interrogation, printing, remote monitoring, and communication between the pulse generator and the health care provider.
Pacemaker/ICD/CRT non-implanted components can be separate pieces or integrated and usually include housings, electronics, processors, software, connectors, and cables.
Pacemaker/ICD/CRT non-implanted components transmit data from the implanted device to the health care provider using telemetry download, and direct or remote transmission.
Pacemaker/ICD/CRT devices are intended to provide therapy to the heart.  The non-implanted components support the implanted devices.
Dengue virus serological reagents are devices that consist of antigens and antisera for the detection of anti-dengue antibodies, individuals that have signs and symptoms consistent with dengue. The detection aids in the clinical laboratory diag
To provide selected flow rates and pressures of co2 gas to separate tissue planes so the saphenous vein or radial artery can be isolated and ligated.
An electronic software controlled gas insufflator which can accept CO2 gas from either a tank or central wall supply.  The gas flow rate and pressure can be adjusted by the user.
The insufflator delivers CO2 gas at a controlled flow rate and pressure to separate tissue planes so the saphenous vein or radial artery can be isolated and ligated.
Leg, saphenous vein or arm, radial artery
Galectin-3 is indicated for use in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure.
enzyme linked immunosorbent assay (ELISA)
in vitro diagnostic for use with serum and plasma
device resides on a motorized drawer that is contained in an enclosure, the drawer slides outside of the enclosure for use then retracts into the light-tight enclusure for UV disinfection after use
self disinfecting computer keyboard and touchpad that utilized germicidal ultraviolet light in an enclosure
Mass Spectrometer For Clinical Multiplex Test Systems
A mass spectrometer for clinical multiplex test systems is a device that is intended to measure and sort multiple signals generated by an assay from a clinical sample.  The generated signals are produced by ionizing the compound or biological m
Multiplex mass spectrometer. The device may integrate sample preprocessing/work station, liquid or gas chromatography, raw data storage mechanisms and other essential hardware and software components along with the basic modules of a mass spect
Provides fixation and sealing between and endovascular graft and the native artery.
The system is comprised of the implant device and an endovascular delivery device used to implant the endovascular suture.
Uses a metallic implant, delivered through a catheter-based system, to affix the material of an endovascular graft to native vessel
The implant is to be placed at the proximal end of an aortic aneurysm.
Test for the quantitative determination of gabapentin in human serum or plasma.  Gabapentin concentrations can be used as an aid in management of patients treated with gabapentin.
Non-Sars Coronavirus Multiplex Nucleic Acid Assay
A non-SARS coronavirus multiplex nucleic acid assay is a multiplex in vitro diagnostic test for the simultaneous qualitative detection and discrimination of coronavirus 229E, coronavirus NL63, coronavirus HKU1 and Coronavirus OC43 nucleic acids
For use as an adjunctive device during open surgical procedures in order to prevent fluid accumulation within the operative site after closure of the surgical wound.  The device is indicated for use in thoracic surgical procedures.
The system comprise of a silicone drainge tube, guide tube with integrated magnetic shuttle assembly.
The system employs a magnetic clearance mechanism integrated into the drainage tubing to allow the user to clear materials which may accumulate inside the drainage tube.
For use in chest areas following thoracic surgical procedures.
Femtosecond Laser System For Refractive Correction
Ophthalmic femtosecond laser intended to provide refractive vision correction by modification of the shape of the cornea
The device consists of a laser console, a computer with graphic user interface, a beam delivery system that positions and focuses the laser beam, patient bed, and a patient interface system that flattens the cornea and holds the patient's eye s
The laser console generates femtosecond laser pulses. When focused in transparent tissue, these low energy pulses produce photodisruption (a highly localized region of ionized plasma) effects that occur on an extremely short time scale and are
Mesh, Surgical, For Stress Urinary Incontinence, Male
surgical treatment of male stress urinary incontinence post-prostatectomy
biologic (e.g., collagen) and/or synthetic (e.g, metallic or polymeric) woven fabric of varying design and material properties
permanently implantable sling placed under the urethra; during instances of increased abdominal pressure (e.g., coughing, laughing, sneezing, etc.), device applies pressure to the urethra to prevent urine leakage
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Surgical treatment of female stress urinary incontinence due to intrinsic sphincter deficiency (isd) and/or urethral hypermobility
synthetic woven or non-woven fabric of varying material properties (e.g., density, pore size, weave, resorption, etc.); design can be pre-configured or can be a sheet to allow surgeon to cut mesh to desired size and shap
placed under the urethra transvaginally using a transobturator (one vaginal incision and two groin/upper thigh incisions) or retropubic (one vaginal incision and two abdominal incisions) approach; during instances of increased abdominal pressur
Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
Bridging material to attach the vaginal apex to the anterior longitudinal ligament of the sacrum; Procedures include abdominal sacrocolpopexy and laparoscopic sacrocolpopexy.
synthetic woven or non-woven fabric of varying material properties (e.g., density, pore size, weave, resorption, etc.); design can be pre-configured for specific repair or can be a sheet to allow surgeon to cut mesh to desired size and shape
permanent implant placed transabdominally that provides mechanical support and/or serves as a bridging material for suspending the vaginal apex or uterus from the sacral promontory.
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
Tissue reinforcement of the fibromuscular layer of the pelvic floor when surgical treatment is indicated; Procedures include anterior and posterior vaginal wall prolapse repair and vaginal apical or uterine prolapse repair performed transvagina
synthetic woven or non-woven fabric of varying material properties (e.g., resorption, density, pore size, weave, etc.); design can be pre-configured for specific repair or can be a sheet to allow surgeon to cut mesh to desired size and shape
permanent implant placed transvaginally that provides mechanical support for weakened tissues of the pelvic floor
For research use only and for products imported into the US only.
Research Use Only/Clinical Chemistry Devices
Foot Wrap For Treating Restless Leg Syndrome Symptoms
Applying compression to the muscles of the foot for the purpose of affecting nerve impulses sent to the central nervous system.
Applies pressure to the abductor hallucis and abductor hallucis brevis adequate to affect the peripheral nervous system.
Abductor hallucis and abductor hallucis brevis muscles.
Graft Insertion Instrument For Endothelial Keratoplasty
A graft insertion device for endothelial keratoplasty is a device intended to be inserted into the eye during surgery to direct the insertion of a corneal graft and be removed after insertion is completed.
Multiple different configurations may exist: similar to intraocular lens guide/injector, retractable spatula, multiple component systems, etc. Design is meant to specifically deliver corneal graft into eye.
A graft insertion device for endothelial keratoplasty functions as a protective guide for the insertion of a donor corneal graft through a corneal incision. Once the graft tissue has been loaded into the insertion device, the device is inserted
Instrument For Treatment Of Hyperhidrosis
The System consists of the following components: the Console; the Handpiece; and a disposable tip that snaps onto the Handpiece.
Norovirus serological reagents are devices that consist of antigens and antisera for the detection of anti-norovirus antibodies or norovirus antigens. The detection aids in the clinical laboratory diagnosis of norovirus infection in individuals
ELISA-based or immunological based assays.
A micro total analysis instrument system is a clinical multiplex instrument intended to measure and sort signals generated by fluorescently-labeled immune complexes from a clinical sample on a microcapillary chip.  Signals may be quantified usi
Should not include microarray systems or standard immunoelectrophoresis systems.
A micro total analysis instrument system is an automated instrument for clinical multiplex test systems which uses electrokinetic mixing and isotachophoresis on a microfluidic chip to create immune complexes between target analyte(s) from a cli
A medical device data system (mdds) is a device that is intended to provide one or more of the following uses, without controlling or altering the functions or parameters of any connected medical devices:  (i) the electronic transfer of medical
Software algorithms to perform necessary medical communication functions
Hand held device with a range of electrodes (64-144) that penetrate the top layer of the skin and then generates RF pulses to create micro-ablative points.
Applicator emits RF energy that flows between electrodes to create micro-ablative points on the skin, forming superficial ablation with a volumetric non ablative heating effect in the dermis.
High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist
To provide high level disinfection of ultrasound transducers.    If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, availabl
Ultrasonic transducer reprocessor, high level disinfectant mist, and accessories
Automatically generates a mist from a dedicated hydrogen peroxide disinfectant solution and exposes a suspended ultrasound transducer to the disinfectant mist at a specified temperature and for a specified time to achieve high level disinfectio
Surgical Mask With Antimicrobial/Antiviral Agent
A single use, disposable surgical mask for occupational use to cover the nose and mouth of the wearer to protect from the transfer of microorganisms,body fluids and particulates and has an added antimicrobial and/or antiviral agent which kills
The device is a surgical mask composed of at least 3 layers of filtration material with bands or ties to secure it to the head, a flexible noseband and an added, specified antimicrobial and/or antiviral agent added to the surgical mask
Device uses a combination multiple filtration layers to protect from the transfer of microorganisms, body fluids and particulates plus the addition of an antimicrobial and/or antiviral agent which kills specified pathogensunder  specified conta
The device is worn over the nose and mouth and is intended to protect the respiratory tract from transfer of microorganisms, body fluids and particulates.
A thermocycler is an automated laboratory apparatus intended to amplify specific segments of double stranded nucleic acids isolated from a clinical sample via the polymerase chain reaction process. The nucleic acid sequences are amplified in th
Should not include real-time thermocyclers or instruments with analyzers for fluorescence, other measuring techniques, or detection methods or integrate sample and/or reagent handling.
A thermocycler is intended amplify specific sequences of double stranded nucleic acids using the polymerase chain process. The device includes a thermal block with holes designed to accommodate the insertion of special tubes or plates holding t
Adaptometer (Biophotometer), Software-Based Data Acquistion And Stimulus Generation
Measurement of retinal adaptation (regeneration of the visual purple) and absolute visible sensitivity to light.
The device is typically plastic or metal enclosed and desk top-based. In the enclosure are electronic components, including a light source, measurement components. and electronics containing software for data acquisition and stimulus generation
A light source stimulates the retina and the the time required for retinal adaptation (regeneration of the visual purple) is measured. The minimum light threshold is also determined, in this same fashion.    Stimulus generation and data acquisi
Powered Surgical Instrument For Improvement In The Appearance Of Cellulite
Used for controlled release of subcutaneous tissue for improvement in the appearance of cellulite.
The device consists of a cutting blade powered by a motor and a means for instrument guidance to control the areas of subcutaneous tissue cutting underneath the cellulite depressions or dimples.
The device temporarily improves the appearance of cellulite by controlled release (cutting) of the subcutaneous tissue underneath the cellulite depressions or dimples.
Area with Cellulite, Fibrous Septae, Fat, Soft Tissue.
may be used with bone graft, should not be used with bone cement
bridges both sides of the joint, preventing motion
Methicillin Resistant Staphylococcus Aureus/Methicillin Susceptible Staphylococcus Aureus Blood  Culture Test Bt
The  mrsa/mssa blood  culture test-bt  is a qualitative  ivd test using bacteriophage amplification for the identification of  staphylococcus aureus and the determination of  meca mediated methicillin resistance or methicillin susceptbility  di
Kit consisting of plastic capped tubes, pipets, lateral flow cassette and liquid reagents
Treatment of wide-necked and larger or giant intracranial aneurysms.
Infant Positioner, Rx, Use In Highly Monitored Setting
Designed to position the baby at a 30 degree angle in the prone (on his/her stomach) position for specific medical or surgical conditions.  For use only when in a highly monitored setting with continuous cardio-respiratory and oxygen saturation
DEVICE MAY BE WEDGE SHAPED TO MAINTAIN THE INFANT AT A 30 DEGREE ANGLE. MAY ALSO HAVE A COMPONENT THAT IS USED TO HELP MAINTAIN THE INFANT ON THE POSITIONER SUCH AS A BINDER.
Trichomonas Vaginalis Nucleic Acid Amplification Test System
In vitro nucleic acid amplification test for the qualitative detection of ribosomal rna from trichomonas vaginalis as an aid in the diagnosis of trichomoniasis from vaginal, cervical, urogenital and gynecological specimens from symptomatic pati
May include target capture, transcription-mediated amplification, semi automated analyzer
Uses target capture, transcription-mediated amplification and hybridization protection assay technologies to stream line specimen processing, amplify target rRNA and detect amplicon respectively
Vaginal, cervical,endocervical, urogenital and gynecological specimens
Nucleic Amplification Assays For The Detection Of Leishmania Nucleic Acids
Detection of  Leishmania species in skin lesions.
Nucleic Acid Amplification assay containing probes and primers
Complete Gene Expression Profiling Accessory Reagents
Complete gene expression profiling accessory reagent kits include all components necessary to perform transcript synthesis, fluorescent labeling, and detection and are intended to carry out all processing steps for separately cleared gene expre
Should not include reagents to perform only part of gene expression assay processing steps (e.g., transcript synthesis but not labeling) or only individual components insufficient to carry out all processing steps or only RNA extraction and pur
Complete accessory reagents for gene expression profiling are intended, designed, and optimized to carry out all assay processes.  The reagents include all components, including enzyme mixes, labeling reagents, reaction buffers, and purificatio
To enhance mechanical thrombus dissolution and acceleration of thrombolysis in patients suffering acute ischemic stroke.
made of mostly plastic and has an adjustable frame
Uses ultrasound transducers mounted on a headframe to deliver transcranial ultrasound at diagnostic levels.
Intervertebral Fusion Device With Integrated Fixation, Lumbar
Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.
Hollow cylinder or rectangular box made of metal or polymer with integrated fixation.
Acts as a disc spacer and holds bone graft; also includes some form of integrated fixation to maintain stability by direct purchase into the bony vertebral endplates.
Intervertebral Fusion Device With Integrated Fixation, Cervical
Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.
Assay, Direct, Nucleic Acid Amplification, Q Fever
These reagents are nucleic acid primers and probes intended for the amplification and identification of Coxiella burnetii directly from clinical specimens. The identification aids in the diagnosis of Q Fever and provides epidemiological informa
A kit that contains reagents and an instrument that measures flourescence.
The Q Fever assay uses a real-time thermocycler. A real-time thermocycler is intended to identify and/or quantify the presence of specific sequences of double stranded DNA, amplified from a biological source and labeled with fluorescently label
Magnetic Cell Selection System For Cd34+ Cells From Hpc-Apheresis Used In Treatment Of Acute Myeloid Leukemia (Aml)
For processing hematopoietic progenitor cells-apheresis (HPC-A) from an HLA-identical donor to obtain a CD34 positive cell enriched population that will provide for hematopoietic reconstitution following a myeloablative preparative regimen with
Anti-CD34 Antibody, Paramagnetic dextran beads, Tubing, Permanent Magnet, Software controlled pumps and valves, Buffers, Filters, Polymer Bags
To select CD34+ hematopoietic progenitor cells from apheresis (HPC-A) labeled with antibody conjugated to paramagnetic beads using a semiautomated magnetic column.
Hematopoietic Progenitor Cells-apheresis (HPC-A) separated from whole blood.
Pulse Generator, External Pacemaker, Dual-Chamber
A dual chamber external pacemaker is intended to provide temporary dual chamber cardiac pacing as a substitute for the heart's intrinsic pacing system until a permanent pacemaker can be implanted, or to control irregular heartbeats following ca
A system generally includes the pulse generator, extension cables, and adaptors.  The pulse generator has a power supply and electronic components capable of data input, data output, and data processing.
The device is used with either an endocardial (transluminal) or epicardial cardiac pacing leads system to deliver a period electrical pulse which stimulates the heart.
This device is used in the right atrium and right ventricle only.
The CYFRA 21-1 EIA kit is intended for the quantitative determination of soluble cytokeratin 19 fragments in human serum. The assay is to be used as an aid in monitoring disease progression during the course of disease and treatment in lung can
plastic microtiter plate, plate reader system
Enzyme immunoassay to quantify soluble cytokeratin 19 in human serum.
Removal of free light chains for the treatment of dialysis dependent acute renal failure secondary to cast nephropathy in patients with multiple myeloma.
The high cut-off technology hemodialyzer is characterized by larger membrane pore sizes resulting in a nominal cut off-point of 100 kilo Daltons (kDa) allowing removal of circulating substances with molecular weights up to a value of approximat
The high cut-off technology hemodialyzer is used on a conventional hemodialysis system with controlled ultrafiltration for the removal of free light chains.   During therapy, anticoagulated blood taken from the patient flows via a tubing system
External communicating device in contact with circulating blood.
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm
Prosthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation
Intended as a primary joint replacement prosthesis in total hip arthroplasty.
metal femoral stem, ceramic femoral head, metal acetabular liner designed to fit within a metal acetaublar shell
comprised of a metal liner designed to fit within a compatible acetabular shell which articulates with a compatible ceramic  femoral head attached to a femoral stem as part of a primary total hip joint replacement system
Chronic Lymphocytic Leukemia Fish Probe Kit
The CLL FISH Probe Kit is intended to detect deletion of the LSI TP53, LSI ATM, and LSI D13S319 probe targets and gain of the D12Z3 sequence in peripheral blood specimens from untreated patients with B-cell chronic lymphocytic leukemia (CLL). T
Reagents for B-cell chronic lymphocytic leukemia prognosis
The device provides verbal instructions pertaining to various first aid and common medical emergencies. The device does not contain any drug or supporting device that could be applied to the patient.
The device looks and functions like a programmable digital audio player, playing digital audio clips as individual digital audio files containing prerecorded, spoken First Aid information in a prescribed order (and language) as user pushes spec
The device works as an audio player playing various first aid instructions when buttons labeled with those first aid emergencies such as choking, burn are pressed.
The instructions are verbally relayed to the user for emergencies pertaining to CPR, Unconscious, Choking, Breathing, Allergic Reaction, Bleeding, Burns, Falls, Bone Injury, Poison, Bites, Stings, Seizures.
Partial water immersion during labor in hospitals, birth centers and home.
Labor pools/tubs are structures intended to hold water which may be heated.  They may be portable structures which are inflated or easily assembled which are filled using a hose or fixed structures which make use of fixed plumbing.   They may b
The pool/tub provides a water environment in which a pregnant woman may labor.
The liquid chemical processing system is intended as a standard method for routine monitoring.
The liquid chemical processing monitor consists of a filter paper-based carrier (1/4 in x 1&#8540;  in) inoculated with G. stearothermophilus 7953 spores and packaged in a glassine envelope, a vial containing 5 ml of modified Trypticase Soy Bro
The device is placed in the system with the load.  During the processing cycle, the liquid chemical processing monitor is exposed to the liquid chemical.  Some of the spores on the strip will be killed and and some of the spores will be physica
Intended for small bone fixation in fracture, osteotomy, and arthrodesis applications.
Supplied with various surgical instruments, may include stainless steel applicator tube, wire, gauge, pin plunger, arthroscopic kit.
This is a device that consists of a stiff wire segment or rod made of resorbable polymer and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed,
For various anatomic locations including knee, hand, finger and toe.
Anti-helicobacter pylori  rabbit monoclonal primary antibody is designed to qualitatively detect the presence of helicobacter pylori in formalin-fixed, paraffin-embedded gastric biopsy tissue via light microscopy. Immunohistochemical staining w
Benchmark series instruments: BenchMark XT and BenchMark ULTRA auto slide stainer; recombinent rabbit monoclonal primary antibody directed against whole Helicobacter pylori organism
Uses immunohistochemical staining methods to qualitatively detect Helicobacter pylori in paraffin-embedded, gastric biopsy tissue
Helicobacter pylori in paraffin-embedded, gastric biopsy tissue
Acts as a bone anchor for temporary stabilization, or used in conjunction with other medical implants of similar metals when wiring is needed, during development of a spinal fusion.
Wrapped around a portion of the sublaminar, posterior spine for temporary stabilization during spinal fusion procedures. May be used in conjunction with other medical implants made of similar metals whenever wiring may help secure the attachmen
Early Growth Response 1 (Egr) Fish Probe Kit
The egr1 fish probe kit is intended to detect deletion of the lsi egr1 probe target in bone marrow specimens and may be used, in addition to cytogenetics, other biomarkers, morphology, and other clinical information, at the time of diagnosis as
Device is a kit containing labeled FISH Probes
Detection of Early Growth Response Gene (EGR1) by fluorescence in-situ hybridization.
Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers
Determines rate of increase of total prostate specific antigen at ultrasensitive concentration levels (picogram/ml serum), and identifies those patients following prostatectomies which are at reduced risk for recurrence of prostate cancer.
Capture antidbody, DNA-labeled antibody and PCR reagents. Software
Uses Immuno-PCR technology.  Ultrasensitive levels (picograms/ml concentration) of total prostate specific antigen are captured in a sandwich immunoassay using DNA-labeled antibody.  The sandwich is detected by Polymerase Chain Reaction exponen
Mechanically maintain patency following ethmoid sinus surgery. By also eluting drugs, reduce the need for post-operative intervention such as surgical adhesion lysis and/or use of oral steroids.
Biological Sterilization Process Indicator With Recombinant-Dna Plasmid
A Recombinant-DNA plasmid biological indicator is intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization.
Bacterial spores containing recombinant-DNA plasmids are provided in an ampoule with a separate, contained compartment of appropriate growth media. The ampoule design should segregate the spores from the growth media until incubation and facili
The device consists of known number of genetically-modified bacterial spores, with known resistance to the intended sterilization process, containing deliberately introduced recombinant-DNA plasmids. The plasmids provide a new indicator signal
The device is intended to be included with sterilization loads, within sterilization wraps, containers, pouches, trays and cassettes during sterilization cycles for which the use of this device has been validated.
Mesh, Surgical, Non-Absorbable, Facial Implants For Plastic Surgery
For reinforcement of soft tissue where weakness exists in facial plastic surgery.
A plastic polymer mesh; either square, rectangular, or round.
A non-absorbable mesh that reinforces soft tissue.
Mesh, Surgical, Collagen, Plastics, Facial Implants
A collagen mesh; either square, rectangular, round, or of other various shapes.
A collagen mesh that reinforces soft tissue.
Mesh, Surgical, Absorbable, Abdominal Hernia
For reinforcement of soft tissue where weakness exists during hernia repair.
An absorbable mesh; either square, rectangular, round or of various other shapes.
An absorbable mesh that reinforces soft tissue
Including but not limited to abdominal, inguinal, femoral, umbilical, and incisional hernias.
Mesh, Surgical, Non-Absorbable, Diaphragmatic Hernia
For reinforcement of soft tissue where weakness exists during diaphragmatic hernia repair.
A non-absorbable mesh; either square, round, rectangular or of various other shapes.
Mesh, Surgical, Collagen, Diaphragmatic Hernia
A collagen mesh; either square, round, rectangular or of various other shapes.
Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
For reinforcement of soft tissue where weakness exists during tendon repair procedures.
An absorbable mesh; either square, rectangular, round or of other various shapes
Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon
For reinforcement of soft tissue where weakness exists in tendon repair.
A non-absorbable mesh; either square, rectangular, round or of other various shapes.
Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
A collagen mesh; either square, rectangular, round or of various other shapes.
Mesh, Surgical, Absorbable, Thoracic, Chest Wall Reconstruction
For reinforcement of soft tissue where weakness exists during chest wall reconstruction.
Mesh, Surgical, Non-Absorbable, Thoracic, Chest Wall Reconstruction
A non-absorbable mesh; either square, rectangular, round or of various other shapes.
A non-absorbable mesh that reinforces soft tissue
Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction
A collagen mesh that reinforces soft tissue
Mesh, Surgical, Absorbable, Staple Line Reinforcement
For reinforcement of soft tissue where weakness exists during staple line reinforcement procedures.
Mesh, Surgical, Non-Absorbable, Staple Line Reinforcement
Mesh, Surgical, Collagen, Staple Line Reinforcement
A collagen mesh; either square, rectangular, round or of various other shapes
Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
For reinforcement of soft tissue where weakness exists in plastic and reconstructive surgery.
An absorbable mesh; either square, round, rectangular or of various other shapes.
An area in need of plastic and reconstructive surgery
Mesh, Surgical, Non-Absorbable, Plastic And Reconstructive Surgery
A plastic polymer mesh; either square, round, rectangular or of various other shapes.
Areas in need of plastic and reconstructive surgery
Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery
Mesh, Surgical, Absorbable, Large Abdominal Wall Defects
For reinforcement of soft tissue where weakness exists in abdominal wall defects.
Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects
A non-absorbable mesh; either square, round, rectangular or of various other shapes
Mesh, Surgical, Collagen, Large Abdominal Wall Defects
Mesh, Surgical, Absorbable, Organ Support
For reinforcement of soft tissue where weakness exists during organ support.
An absorbable mesh; either square, rectangular, round or of various other shapes
Various organs in need of temporary support
For reinforcement of soft tissue where weakness exists during the repair of fistulas.
An absorbable mesh; round, rectangular, square or of various other shapes
An absorbable mesh for the reinforcement of soft tissue.
Anorectal, enterocutaneous, and recto-vaginal fistulas
A collagen mesh; square, rectangular, round or of other various shapes
A collagen mesh for the reinforcement of soft tissue
Dna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment
X/Y DNA probe kit is intended to detect alpha satellite sequences in the centromere of chromosome (Chr) X and satellite III DNA at Yq12 of Chr Y along with routine diagnostic cytogenetic testing. It is indicated for use as an adjunct to standar
Reagents for monitoring engraftment of sex mismatched bone marrow transplantation for hematological disorders
fluorescence in situ hybridization (FISH)
opposite-sex bone marrow transplantation for hematological disorders
Measures levels of a chemotherapy drug in the blood.
Measures levels of a chemotherapy drug in the blood
Percutaneous Surgical Set With Attachments
Minimally invasive devices with the means to penetrate soft tissue to access the abdomen.  The attachment and the shaft will be assembled and disassembled within the abdomen before and after use. The devices are used to grasp, hold, and manipul
A shaft plus end effector attachments with different sizes
A shaft of the device that can penetrate through soft tissue; attachments that will be delivered through a traditional conduit (such as a trocar) and assembled with the shaft inside the abdomen.
Stimulator, Electrical, Transcutaneous, For Diabetic Retinopathy
Electrical stimulation unit with leads and cutaneous electrodes used to apply an electrical current through the electrodes to the patient's eyelid to create a microcurrent loop that flows through the retina.
Applies an electrical current through electrodes on a patient's eyelid (skin)
A pediatric/child facemask is intended to be worn by the patient/child to provide protection for the respiratory tract.   It is a single use, disposable device that is provided non-sterile.   The facemask is recommended for use in a healthcare
A pediatric/child facemask is constructed of nonwoven materials. A nosepiece is placed within the bindings for comfort and individualized fit. It is appropriately sized to the smaller faces of children across a diverse population.  It is intend
Quantitative determination of [-2]proPSA antigen in human serum to be used in combination with total PSA and free PSA to calculate the Prostate Health Index (phi)
Reagent packs, calibrators, controls, substrate and wash buffer
A two-site immunoenzymatic assay using paramagnetic particles coated with a mouse monoclonal anti-[-2]proPSA antibody to capture the [-2]proPSA and mouse monoclonal anti-PSA alkaline phosphatase conjugate that reacts with a chemiluminescent sub
Kit, Rna Detection, Human Papillomavirus
For the detection of human papillomavirus RNA to aid in assessing risk of cancer.
Device is supplied as an in vitro diagnositc kit containing various reagents, instructions for use and possibly instrumentation and software.
Utilizes nucleic acid probes and/or primers along with other reagents to detect human papillomavirus RNA directly from human specimens
Currently, this type of device is only utilized on cervical specimens, but other specimen types are possible.
Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
The insulin pump is intended to be used as a component of an invasive glucose device.  The pump is designed to pump fluid (insulin) into a patient in a controlled manner as an aid in the mangement of diabetes mellitus in persons requiring insul
Must include product code MDS, sensor, glucose, invasive test system
The pump is designed to pump fluid (insulin) into a patient in a controlled manner as an aid in the mangement of diabetes mellitus in persons requiring insulin. It is intended to accept and display data from the glucose sensor
Optical Diagnostic Device For Melanoma Detection
Intended in the detection of melanoma and high grade lesions among atypical lesions in order to rule-out melanoma.
Use of visible and infrared optical radiation to generate images of targeted atypical lesions.
Flow Cytometric Reagents And Accessories.
To identify and classify cells or other particles in suspension by their inherent physical properties or associated fluorescent molecules in order to provide information about the distribution or  number cells in suspension or their level of pr
May include flow cytometers, monoclonal antibodies, lysis reagents, processing reagents, automated processing devices or pipetting devices.
Particles in suspension may be treated with fluorescent conjugated antibodies or fluorogenic compounds followed by interrogation in a flow cytometer that enumerates and characterizes each particle based on its physical and fluorescent character
Peripheral whole blood specimens, lymphoid biopsies, and neoplastic tissues.
Percutaneous gastric implant to remove stomach contents after eating for weight loss in the treatment of obesity in adults
Immunoassay for the in vitro quantitative determination of soluble ST2 protein in human serum and plasma.
An orthodontic accessory intended for use during orthodontic treatment. It is used in conjunction with orthodontic appliances such as braces and helps facilitate minor anterior tooth movement.
The system consists of four components: The Activator, Mouthpiece, Charging Port, and Travel Shell.
The device functions by providing vibration to the teeth.  This is done for 20 minutes a day per the length of the entire treatment.
To perform non-bronchoscopic bronchoalveolar lavage (bal) in adult patients undergoing mechanical ventilation.
The device is inserted into a patient's lungs to collect bronchoalveolar labage specimens
A collection device intended for use in the non-invasive collection of saliva samples for clinical dna testing.
Collects DNA in saliva and stabilizes it for transport or storage
Intended to be used to assist in the implantation of a specific ankle arthroplasty device.  Indicated to include guiding alignment, making or establishing cuts, and sizing.
A device accessory or a set of device accessories.
Aids the surgeon in performing the implantation of an ankle arthroplasty device.
An in vitro diagnostic device intended as an aid in the clinical diagnosis of patients with a suspicion of systemic mastocytosis in conjunction with other clinical and laboratory findings.
Prostrate Cancer Genes Nucleic Acid Amplification Test System
An in vitro nucleic acid amplification test that measures the concentration of prostate cancer genes.
Capture oligonucleotides, magnetic microparticles, transcription-based nucleic acid amplification reagents, chemiluminescent-labeled nucleic acid probes. luminometer, software
Utilizes nucleic acid probes and/or primers along with other reagents to detect prostrate cancer genes RNA from human specimens.
Currently this type of device is only utilized on urine specimens, but other specimen types may be possible.
Intravaginal culture of human gametes and embryos.  To hold and maintain gametes and developing embryos over the duration of the intravaginal culture period.
Culture device designed to hold and maintain gametes and embryos during intravaginal culture procedures.
The anti-jcv antibody detection assay is intended for the detection of antibodies to the john cunningham virus (jcv) in serum or plasma samples from multiple sclerosis (ms) and crohn's disease (cd) patients receiving immunomodulatory  therapies
A serological test for the detection of the presence on anti-JCV specific antibodies in serum or plasma samples by an enzyme linked immunosorbent technology
Enclosed bed canopy system used as passive restraint.
It may consist of the following components:  (a) Metal/aluminum  rectangular frame  (b) Polyurethane or like material for tubular foam padding for the aluminum frame  (c) Four side panels composed of polyurethane-coated nylon pack cloth, gray p
It is a passive bed enclosure that provides a solid framework and a soft canopy structure, which securely attaches to the bed and shelters and restrains the patient without touching the patient.  The canopy provides access to the patient throug
Blood Establishment Computer Software, User Developed
To store information that blood establishement personnel use to make decisions concerning the suitability of blood and blood products for further manufacture or transfusion.
Detection of alpha satellite sequences in the centromere regions of human chromosomes in conjunction with routine diagnostic cytgenetic testing.  It is indicated for use as an adjunct to standard cytogenetic methaphase analysis a identifying an
Reagents for identifying and enumerating human chromosomes
The trinucleotide repeat disorder dna test is an in vitro diagnostic device intended to amplify and detect the presence of specific triplet nucleotide repeats to aid in the diagnosis of genetic inherited disorders associated with mental retarda
Gene region specific amplification test system.  Should not include products not intended for export only or for products intended for re-importation into the USA
Uses polymerase chain reaction (PCR) and amplicon fragment sizing on a DNA genetic analyzer or capillary electrophoresis platform to determine the number of triplet repeats.
Peripheral human whole blood or human tissue.
For the removal of fat through laser lipolysis.
Laser system using fiber optic delivery system to deliver the laser energy to the site through a cannula
delivery of laser energy via a cannula into the subdermal area to dissolove fat and disrupt the septae that affect the appearance of cellulite
Leukemia Translocation Panel Multiplex Test
The leukemia translocation panel multiplex test is a qualitative in vitro diagnostic device intended to identify specific fusion transcripts by reverse-transcriptase polymerase chain reaction (rt-pcr) from whole blood or bone marrow.  It is int
Mulitplex qualitative chromosome translocation amplification test system. Should not include products not intended for export only or for products intended for re-importation into the USA
The test uses a multiplex reverse-transcriptase polymerase chain reaction (RT-PCR) with multiplex fluorescent real-time PCR or bead-based array detection system
Peripheral human whole blood or bone marrow
Group A Streptococcus Nucleic Acid Amplification Assay System
An in vitro diagnostic test for the detection of Streptococcuc pyogenes (Group A beta hemolytic Streptococcus) in throat swab specimens from symptomatic patients.
May include automated/manual isothermal nucleic acid amplification, polymerase chain reaction, ligase chain reaction, sequence-based amplification
Uses nucleic acid amplification technology to detect Group A Sreptococci
Test, Urea Adult And Pediatric (Breath),
Intended for use in the qualitative detection of urease associated with h. Pylori in the human stomach and is indicated as an aid in the initial diagnosis and post-treatment monitoring of h. Pylori infection in adults and pediatric patients. Th
System utilizes an Infrared Spectrophotometer
Dengue Nucleic Acid Amplification Assay (Naat)
A qualitative in vitro diagnostic assay for the detection of dengue  virus serotypes 1, 2, 3 or 4 in serum or plasma specimens collected from human patients with signs and symptoms consistent with dengue (mild or severe).
Dengue nucleic acid amplification and detection reagents including primers and probes, positive controls, and human specimen extraction control
Uses nucleic acid amplification technology for detection of dengue virus target sequences
Human clinical samples e.g., blood serum, plasma
Temporary Non-Roller Type Left Heart Support Blood Pump
A blood pump that provides temporary full or partial left heart support
Rotor or axial type pump manufactured of various materials.  Single use, disposable.
pumps part or all of the patient's blood circulation either during an adjunctive procedure where the patient requires hemodynamic stability, or a temporary use of the device to unload the heart to give it time to recover from an acute condition
Influenza A And Influenza B Multiplex Nucleic Acid Assay
An Influenza A and Influenza B multiplex nucleic acid assay is a multiplex in vitro diagnostic test for the simultaneous qualitative detection and discrimination of influenza A and influenza B nucleic acids isolated and purified from human resp
Tissue Rna Preservative For Collection, Storage, And Transportation
The human tissue RNA preservation collection, storage, and transportation tube is a single-use, prefilled container intended for the collection, storage, and transportation of fresh human tissue specimens for subsequent RNA isolation and furthe
consists of different sized tubes and volumes of preservative solution with a leak proof polyethylene cap.
Uses a special tissue preservation solution to preserve and stabilize RNA in tissue specimen for transport and later isolation and testing.
For the treatment of defects in the atrial septum and closure of atrial septal defects via transcatheter technique.
permanent implant placed in septum (usually constructed of a combination of metals/polymers that is placed via a venous catheter system)
percutaneous venous puncture and interventional technique
For the treatment of defect in the ventricular septum and closure of ventricular septal defects via transcatheter technique.
permanent implant placed in septum, usually constructed of a combination of metals/polymers that is placed via a catheter system
percutaneous puncture and interventional technique
The hinged internal fixator is intended to treat joint dislocations, more specifically of the elbow joint.  The device is intended to be removed once stability is achieved.
The hinged internal fixator consists of titanium and cobalt chromium components
The hinged internal fixator secures the elbow joint by means of a plate and screws on the ulna attached to a pin that is inserted into the humerus.
The hinged internal fixator is intended for use in the elbow joint.
To measure the temperature of exhaled human breath, which is frequently increased in airway inflammation in asthma patients. Measurement of changes in exhaled human breath temperature aids in evaluating airway inflammation treatment in asthma p
The major components of the device are:  a.	A 0.5-litre silver plated flask in a metal cylinder (thermos)  b.	An air tube and thermal block made out of copper with an in-built temperature sensor. The thermal block has a tube-like part with high
The essence of the device technology is an environmental chamber with a thermal core heated by exhaled air from the patient. Each exhalation increases the temperature inside the reservoir until equilibrium is reached and measured by a thermal s
C.Difficile Toxin Gene Amplification Assay
Amplification assay for the detection of c. Difficile toxin genes from stool specimens of  symptomatic patients.
Uses amplification technology to detect toxin genes of C. difficile
Artificial Pancreas Device System, Threshold Suspend
An artificial pancreas system that temporarily suspends or reduces insulin infusion from an insulin pump based upon specified thresholds of measured glucose levels.
May include: Continuous glucose monitoring system, sensor, self monitoring blood glucose device, infusion pump, data management software
Uses a glucose monitoring system to measure glucose levels in interstitial fluid or blood and suspends or reduces insulin infusion from an insulin pump
Not meant to act on a specific part of the body but works with other devices - Continuous glucose monitoring system, sensor, self monitoring blood glucose device, data managment software
Artificial Pancreas Device System, Single Hormonal Control
An insulin-only artificial pancreas system that achieves a target glucose level by automatically increasing or reducing insulin infusion from an insulin pump. Insulin adjustments are based upon specified thresholds of measured glucose levels.
Uses a glucose monitoring system to measure glucose levels and increases or reduces insulin infusion from an insulin pump
Not meant to act on a specific part of the body but works with other devices - Continuous glucose monitoring system, sensor, self monitoring blood glucose device, data management software
Artificial Pancreas Device System, Bihormonal Control
A bihormonal artificial pancreas system that achieves a target glucose level by automatically adjusting two glucose modulating therapies from an infusion pump. Hormone adjustments are based upon specified thresholds of measured glucose levels.
Uses a glucose monitoring system to measure glucose levels and increases or reduces two glucose modulating therapies from an insulin pump
This intraoral device is electrically powered and operates by reducing the pressure in the oral cavity (by way of tubing and a noninvasive oral interface) to create a continuous positive pressure gradient from the airway to the oral cavity that
Mouthpiece, Tubing, Negative Pressure Console
A balloon aortic valvuloplasty catheter is indicated for balloon valvuloplasty of the aortic valve.
Generally, a balloon aortic valvuloplasty catheter is a coaxial catheter comprised of outer and inner layers. The catheter features a molded proximal end bifurcated with two distinct luminal passages. The inflation lumen terminates into a dista
The catheter is inserted into the body and directed towards the aortic valve. Once the catheter is placed in the valve, the balloon is expanded which compresses and/or breaks the material causing stenosis.
To provide confirmation of an event co-ingested or coincident with the ingestible component of the device. The wearable component of the device incorporates wireless communication to display the event and other information on a general computin
The system is composed of an ingestible microsensor, a data recorder in the form of a skin patch, and software
The grain-of-sand sized microsensor is designed to communicate the time-stamped confirmation of dosing as a unique identifier to the Proteus ingestion recorder worn on the skin. The ingestion signal is communicated via volume conduction communi
A qualitative in vitro diagnostic assay intended to detect Mycoplasma pneumoniae DNA extracted from human respiratory specimens. Detection of Mycoplasma pneumoniae DNA aids in the diagnosis of Mycoplasma pneumoniae respiratory infection in conj
Mycoplasma pneumoniae DNA detection assay systems are devices that consist of reagents and instruments for the detection of Mycoplasma pneumoniae DNA extracted from human respiratory specimens.
A qualitative in vitro diagnostic assay intended to detect Mycoplasma pneumoniae DNA extracted from human respiratory specimens.
Chlamydophila Pneumoniae Dna Assay System
A qualitative in vitro diagnostic assay intended to detect Chlamydophila pneumoniae DNA extracted from human respiratory specimens. Detection of Chlamydophila pneumoniae DNA aids in the diagnosis of Chlamydophila pneumoniae respiratory infectio
Chlamydophila pneumoniae DNA detection assay systems are devices that consist of reagents and instruments for the detection of Chlamydophila pneumoniae DNA extracted from human respiratory specimens.
A qualitative in vitro diagnostic assay intended to Chlamydophila pneumoniae DNA extracted from human respiratory specimens.
A qualitative in vitro diagnostic assay intended to detect Bordetella pertussis DNA extracted from human respiratory specimens. Detection of Bordetella pertussis DNA aids in the diagnosis of Bordetella pertussis respiratory infection in conjunc
Bordetella pertussis DNA detection assay systems are devices that consist of reagents and instruments for the detection of Bordetella pertussis DNA extracted from human respiratory specimens.
A qualitative in vitro diagnostic assay intended to Bordetella pertussis DNA extracted from human respiratory specimens.
Cytomegalovirus (Cmv) Dna Quantitative Assay
Cytomegalovirus (CMV) DNA Quantitative Assay is an in vitro nucleic acid assay for the quantitative measurement of CMV DNA in human plasma or whole blood. The assay can be used to measure CMV DNA levels serially at baseline and during the cours
In vitro nucleic acid based assay using real-time PCR for the quantitative measurement of CMV DNA
Voltage Gated  Calcium Channel (Vgcc) Antibody Assay
Intended for semi-quantitative determination of VGCC Antibody in human serum. The VGCC Ab may be present in patients diagnosed with Lambert-Eaton Syndrome (LEMS). The assay result is not to be used alone and to be used in conjunction with other
VGCC labeled with 125 Iodine-w-Conotoxin MVIIC (lyophilized) in 12x75 polysterene test tubes; Positive and negative controls; Total Binding & Non-Specific binding tubes; Anti-human IgG; Buffer; Wash solution
Radioimmunoassay (RIA) Assay using radioactive labeled material
Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Transvaginal surgical repair of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) and/or urethral hypermobility.
Non-synthetic woven or non-woven fabric of varying material properties (e.g., density, pore size, weave, resorption, etc.); design can be pre-configured or can be a sheet to allow surgeon to cut the mesh to desired size and shape.
Placed under the urethra transvaginally using a transobturator (one vaginal incision and two groin/upper thigh incisions) or retropubic (one vaginal incision and two abdominal incisions) approach; during instances of increased abdominal pressur
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
Synthetic woven or non-woven fabric of varying material properties (e.g., density, pore size, weave, resorption, etc.); design can be pre-configured or can be a sheet to allow surgeon to cut mesh to desired size and shape.
With a single vaginal incision, the sling is placed under the urethra; during instances of increased abdominal pressure (e.g., coughing, laughing, sneezing, etc.) the device applies pressure to the urethra to prevent urine leakage.
Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
Tissue reinforcement of the fibromuscular layer of the pelvic floor when surgical treatment is indicated; procedures include anterior and posterior vaginal wall prolapse repair and vaginal apical and uterine prolapse repair completed transvagin
Non-synthetic woven or non-woven fabric of varying material properties (e.g., density, pore size, weave, resorption, etc.); design can be pre-configured for specific repair or can be a sheet to allow surgeon to cut the mesh to desired size and
Permanent implant placed transvaginally that provides mechanical support for weakened tissues of the pelvic floor.
Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
Bridging material to attach the vaginal apex or uterus to the sacral promontory; procedures include abdominal sacrocolpopexy, laparoscopic sacrocolpopexy and robot-assisted sacrocolpopexy.
Permanent implant placed transabdominally that provides mechanical support and/or serves as a bridging material for suspending the vaginal apex or uterus to the sacral promontory.
For open surgical replacement of malfunctioning pulmonic heart valve.
Animal tissue valve that has three leaflets and a ring of either tissue or fabric (called the sewing ring) that accepts sutures for sewing into the patient's annulus.
after being sewn into annulus, the leaflets open and close at appropriate periods in the heart beat cycle to control the flow of blood.
Sutured into the heart in the location where the native pulmonic valve used to reside (pulmonic valve annulus).
Gram-Positive Bacteria And Their Resistance Markers
A qualitive multiplexed in vitro diagnostic device to detect and identify Gram positive bacteria and resistant markers in positive blood cultures.
The BRAF mutation kit is a multiplex qualitative in vitro diagnostic device to identify specific BRAF mutations by multiplex polymerase chain reaction of genomic DNA extracted from formalin-fixed paraffin-embedded (FFPE) colorectal cancer or fi
Multiplex qualitative DNA mutation amplification and detection test system. Should not include products not intended for export only or for products intended for re-importation into the USA.
The test uses multiplex qualitative polymerase chain reaction (PCR) and a multiplex test system (e.g., liquid bead array cytometry, etc.) to amplify and detect specific BRAF mutations.
Formalin-fixed paraffin-embedded (FFPE) colorectal cancer or fine needle aspirated (FNA) thyroid tissue.
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented
Total shoulders are indicated for arthritis (osteo-, rheumatoid, traumatic), avascular necrosis, correction of functional deformity, and revision procedures.
May include:    Humeral stem  Humeral neck  Humeral tray  Glenoid component  Glenoid tray  Glenosphere  Fixation screws  Instrumentation
To be implanted to replace a shoulder joint.  It limits translation and rotation in one or more planes via the geometry of its articulating surfaces.  It has no linkage across the joint.  This generic type of device includes prosthesis that hav
Aortic Heart Valve, More Than Minimally Manipulated Allograft
Intended for use in the replacement of diseased, damaged, malformed, or malfunctioning native or prosthetic aortic valves in pediatric patients.
More than minimally manipulated aortic allograft heart valve
NR2 is an independent blood-borne marker that rules in cerebral ischemic event and rules out hemorrhage.
in vitro diagnostic device using human serum samples
Test, Volatile Organic Compounds Breath Analysis
Aid in the diagnosis of grade 3 heart transplant rejection in patients who have received heart transplants within the preceding year. Intended to be used as an adjunct to, and not as a substitute for, endomyocardial biopsy. The use of the devic
A breath collection apparatus for collection of volatile organic compounds in alveolar breath onto a sorbent trap, as well as for the collection of a separate sample of room air.    o	Analysis of the volatile organic compounds in alveolar breat
Breathe collection device; analysis of the volatile organic compounds in alveolar breath and room air by gas chromatography and mass spectroscopy
Rf/Microwave Hyperthermia System, Cancer Treatment
Used in conjunction with radiation therapy for the treatment of cervical carcinoma patients who normally would be treated with combined chemotherapy and radiation but are ineligible for chemotherapy due to patient related factors.
for the treatment of patients who have complete spinal cord lesions (ASIA Classification) with intact parasympathetic innervation of the bladder and are skeletally mature and neurologically stable, to provide urination on demand and to reduce p
Implantable Receiver-Stimulator, and Extradural Electrodes; External controller (battery powered), External Transmitter, Battery Charger, Power Corc, External Cable and Transmitter Tester; Surgical component -Surgical stimulator, Extradural Sur
Sacral anterior root stimulator intended to provide bladder evacuation by delivering electrical stimulation to the patient's intact spinal nerve root in order to elicit functional contraction of the muscles innervated by them. It consists of im
Electrical stimulation of the urinary bladder in the Gu Tract to provide urination on demand and to reduce post-void residual volumes of urine.
Used to obstruct lower aortic blood flow to augment cerebral perfusion.
A multi-lumen catheter with two balloons mounted near the distal tip
Temporary balloon inflation in the descending aortic artery obstructs or redirect blood flow
Double balloon catheter deployed in the descending aortic artery and hypothesized to increase cerebral blood flow
Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement
Nonabsorbable expanded polytetrafluoroethylene (ePTFE) surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from ePTFE and is intended for use in repair or replacement of chordae tendinae. It may be undyed or dyed
provides tension between the papilary muscles and valve leaflets to prevent valve leaflet prolapse by restoring natural function of the chordae tendinae.
For creating arteriotomies during an intracranial vascular bypass procedure in patients 13 years of age or older with an aneurysm or a skull base tumor affecting a large [> 2.5 mm], intracranial artery that failed balloon test occlusion, cannot
Arteriotomy SystemHUD and extension tubing for connection to a vacuum source. It is comprised of the catheter and the rings.      The Elana Surgical KitHUD should only be used with the US legally marketed Spectranetics XeCl (Xenon-Chloride) Exc
The surgeon attaches the ring  with the donor graft to the artery wall  using a fine suture. Apply suction. For about 2 minutes the catheter tip should be held in steady contact with the artery wall.  After the two minutes, the Excimer laser is
Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction
Over-the-counter treatment of wrinkles and rhytides.
Radiofrequency current generator and electrode applicators
Radiofrequency electrical current (i.e., electrosurgical device)
for the treatment of patients who have complete spinal cord lesions (ASIA Classification) with intact parasympathetic innervation of the bowel and are skeletally mature and neurologically stable, to provide bowel evacuation.
Implantable Receiver-Stimulator, and Extradural Electrodes; External controller (battery powered), External Transmitter, Battery Charger, Power Cord, External Cable and Transmitter Tester; Surgical component -Surgical stimulator, Extradural Sur
Electrical stimulation of the lower bowel in the GI Tract to provide fecal evacuation on demand.
The TAS ECT Test Card is to be used with the TAS Analyzer and is intended to determine the anticoagulant effect of hirudin during CBP in patients who have HIT. It is suited for professional use in decentralized areas of testing near the site of
The system requires pooled normmal human plasma to dilute the citrate whole blood usingpolypropylene plastic tube. The system's performance is monitored by two levels of quality control plasma avialble from Cardiovascular Diagnostics, Inc.
The TAS ECT provides one stage test which measures the clotting time of a plasma diluted, citrate whole blood after combining it with the prothrombin activator, ecarin. It is composed of a thin plastic card in which a flat, shallow reaction cha
Manual Blood Grouping And Antibody Test Systems
A manual blood grouping and antibody test system is used to group red blood cells and to detect antibodies to blood group antigens.
For patients with mitten hand deformities due to Recessive Dystrophic Epidermolysis Bullosa (RDEB)
Composite Cultured Skin (CCS) is an aseptically processed wound dressing composed of a bovine collagen matrix (coated sponge) in which normal human allogeneic skin cells (epidermal keratinocytes and dermal fibroblasts) are cultured in two layer
Device fucntions as a phsycia l cover of a autograft wound site.  It provdies a mosit wound healign environment and physiological components that interact with the acute wound.
Orthopaedic Surgical Planning And Instrument Guides
As a surgical instrument to assist in pre-operative planning and/or guiding the marking of bone and/or guide surgical instruments for orthopedic surgical procedures.
for pre-surgical planning including transfering, visualizing, measuring, annotating and editing medical data.  Patient specific templates that are based on pre-operative plan and are designed to fit a specific patient.  These guides are used to
Embryo Image Assessment System, Assisted Reproduction
The device will obtain and analyze light microscopy images of developing embryos.  This device provides information to aid in the selection of embryo(s) for transfer when there are multiple embryos deemed suitable for transfer or freezing .
Optical imaging system and analysis software
Imaging system that will obtain and analyze light microscopy images of developing embryos.  This device provides information to aid in the selection of embryo(s) for transfer when there are multiple embryos deemed suitable for transfer or freez
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive
For use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, a
System contains acvetabular screws, acetabular shell, constrained UHMWPE acetabular liner doped with an additive, a femoral ball, and a metallic femoral stem.
This device is intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. The liner constrains the head such that it prevent axial dislocation
A cranial distraction system is a metal device intended to establish osteodistraction and bone growth in the skull.  The bone segments are attached to the plate with screws to prevent movement of the segments.
May include: distractors, distraction plates, spacers, screws and instrumentation
Bone segments are attached to the plate with screws to prevent movement of the segments.
Temporary circulatory support < 6 hours of use during off-pump bypass (OPCAB).
A catheter based axial flow impeller pump that is implanted within the heart.  the pump unloads the heart by actively pumping blood from the left veitricle to the aorta for durations of 6 hours or less.
The blood pump is used to support the circulation during surgical procedures (lasting < 6 hours) with or without the use of an oxygenator.
Apheresis For Focal Glomerulosclerosis In Pediatric Patients
Teatment of pediatric patients with primary focal segmental glomerulosclerosis in which standard treatment options are unsuccessful or not well tolerated or treatment of post renal transplantation pediatric patients with recurring primary focal
Composed of four components: a pair of paheresis columns (dextran sulfate cellulose adsorption column soaked in sodium citrate solution); two other disposabel components (a hollow fiber, ethylene vinyl alcohol copolymer-coated polyethylene plas
Blood is pumped from patients arm into the device which then separates blood into cellular components and plasma.  Plasma is then sent thru dextran sulfate cellulose column to remove specific plasma components.  Depleted plasma is then recombin
Plasma components are removed to aid the patients kidneys
Acts as a barrier to the passage of fecal matter through the rectum.
Comprised of a silicone Insert and a plastic fingertip applicator.  The Insert has a barbell shape, the end which sits inside of the rectum ranges in size from 22 mm to 28 mm in width.  The Insert is 35 mm long and the external flare is 24 mm.
Designed for self-insertion to seal and prevent the involuntary leakage of stool from the rectum.
Fixation, Non-Absorbable Or Absorbable,  For Pelvic Use
Attaching suture or stapling ligaments of the pelvic floor.
non-absorbable or absorbable suture or staple; may include instruments and/or tissue anchoring components as part of a kit
provides mechanism for attachment to and/or from ligaments of the pelvic floor
To fill bony voids or gaps of the skeletal system (i.e. the extremities, posterolateral spine and pelvis).
Pre-filled syringe that contains putty composed of bioactive glass particles, polyethylene glycol and glycerol.  Syringe tip permits attachment of cannula. Syringe also includes rotating plunger to aid in controlled dispersion of device.
Extruded from syringe into bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine and pelvis).
Skeletal system (extremities, posterolateral spine and pelvis).
Massager, Vacuum, Radio Frequency Induced Heat
Generates heat in body tissues for minor relief of minor aches and pain. Mechanical massaging to provide a temporary reduction in the appearance of cellulite.
A console that generates the RF energy. It has two handpieces, an RF handpiece to apply energy for the pain relief indication and a mechanical roller handpiece for the cellulite indication.
Increases the temperature of skin by deposition of RF waves to relieve minor aches and pain. It  uses a mechanical roller to reduce the appearance of cellulite.
To temporarily (< 30 days) mark a tissue site intended for surgical removal. The tissue marker is surgically removed with the target tissue.
May include: implantable marker, delivery device
Marks a tissue location by being visible using imaging techniques.
Tissue intended to be removed surgically
A genetic analyzer is an automated clinical multiplex instrument system intended to measure and sort signals generated by multiple fluorescent dyes in order to analyze DNA/RNA molecules in an assay from a clinical sample. Individual nucleotide
Should not include massively parallel or high-throughput sequencers or instruments with analyzers for fluorescence.
Utilizes denatured capillary electrophoresis by separating fluorescently labeled amplified DNA fragments or individual nucleotide bases by size and charge using a polymer-based separation matrix. It may integrate sample and/or reagent handling,
External Cerebrospinal Fluid (Csf) Diversion
Cerebrospinal fluid (CSF) diversion intended to alter spinal cord perfusion.
Diverts CSF in order to alter spinal cord perfusion pressures.
Central nervous system (CNS) subarachnoid and ventricular space.
Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
Used to apply an electrical current to a patient's cranium through electrodes placed on the skin.
Obtains tissue samples from the endocervical canal for histological analysis.
handle and sheath with collection tip; collection tip is designed to scrape endocervical canal and collect an endocervical tissue sample
inserted manually through the vaginal and into the endocervix; collection tip scrapes the endocervical canal and collects endocervical tissue sample
For semi-quantitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum. The assay may be useful as an aid in the diagnosis of autoimmune adrenal disease, whether expressed as autoimmune Addison's disease (isolated) o
RIA Assay Kit with reagents, antigen with I-125, calibrators, controls and assay buffer.
Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
A gastrointestinal pathogen panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal microbial nucleic acids extracted from human stool specimens. Th
Gastrointestinal pathogen panel multiplex nucleic acid-based assay systems are devices that consist of reagents and instruments for the simultaneous detection and identification of multiple gastrointestinal microbial nucleic acids extracted fro
A qualitative in vitro diagnostic assay intended to simultaneously detect and identify multiple gastrointestinal microbial nucleic acids extracted from human stool specimens. The detection and identification of a specific gastrointestinal micro
Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System
A gastrointestinal bacterial panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal bacterial nucleic acids extracted from human stool specimens. T
Gastrointestinal bacterial panel multiplex nucleic acid-based assay systems are devices that consist of reagents and instruments for the simultaneous detection and identification of multiple gastrointestinal bacterial nucleic acids extracted fr
A qualitative in vitro diagnostic assay intended to simultaneously detect and identify multiple gastrointestinal bacterial nucleic acids extracted from human stool specimens. The detection and identification of a specific gastrointestinal bacte
A ventricular assist device (VAD) assists the left or right ventricle in maintaining circulatory blood flow. The device is either totally or partially implanted in the body.
Ventricular assist devices may come in many shapes (depending on pulsatile or continuous flow, and mechanism of function) and sizes (depending on size of the patient). They utilize different functions to achieve replacement of the primary funct
Uses mechanical means to replace function of the left and/or right ventricles. For left ventricular support, blood is pumped from the left ventricle to the aortic arch. For right ventricular support, blood is pumped from the right ventricle to
Enzyme Linked Immunoabsorbent Assay, Rubeola Igm
The qualitative detection of measles specific  IgM antibodies in serum or plasma.
To assist the user with refilling a portable liquid oxygen tank from a reservoir unit by holding the portable liquid oxygen tank in an upright position.
physically maintains the portable liquid oxygen tank in an upright position
portable liquid oxygen tanks and reservoir units
Immunoglobulin G Kappa Heavy And Light Chain Combined
Intended for the in-vitro quantification of IgG kappa concentration in human serum.
Kit is composed of polyclonal monospecific sheep   anti-IgG kappa antibody, IgG kappa Calibrator, 2 IgG kappa Controls, and IgG kappa Supplementary Reagen
Immunoglobulin G Lambda Heavy And Light Chain Combined
Intended for the in-vitro quantification of IgG lambda concentration in human serum. The result is to be used with previously diagnosed IgG multiple myeloma, in conjunction with other clinical and laboratory findings.
Kit is composed of polyclonal monospecific sheep   anti-IgG lambda antibody, IgG lambda Calibrator, 2 IgG lambda Controls, and IgG lambda Supplementary Reagent
Pancreatic Stent, Covered, Metallic, Removable
To facilitate transmural endoscopic drainage of pancreatic pseudocysts
Facilitates and secures the apposition of tissue for transmural placement of stent
pancreatic pseudocysts adherent to bowel wall
To be used to perform and record leakage testing on flexible endoscopes.
The test results are displayed on an LCD monitor. In the MLT mode, the operator determines whether the endoscope has a pinhole by monitoring air bubbles from the endoscope soaked in water. It also uses RFID for recognizing endoscopes and operat
The tester uses two testing modes: (1) automated leak test mode (ALT mode), (2) manual leak test mode (MLT mode). The device detects leaks from the differences in air pressure.
Implantable Pulse Generator, Programmer And Battery Charger
intended for the treatment of moderate to severe heart failure.
resembles an implantable cardiac pacemaker, it differs in that it devlivers it electrical stimulation pulses during the absolute refractory period and therefore does not initiate a cardiac cycle, thus it does not regulate rhythmicity
electricallly stimulates the heart during the absolute refractory period to improve cardiac contractile properties
Artificial Chordae Tendinae Delivery System
Deploys commercially available ePTFE suture, labeled for use as artificial chordae tendinae, while the heart is beating as an alternative to the conventional surgical approach for this type of mitral valve repair.
Investigational use only and for products imported into the US only.
Investigational Use Only - Clinical Chemistry
Investigational Use Only - Clinical Toxicology
Immunoglobulin M Kappa Heavy And Light Chain Combined
Intended for the in-vitro quantification of IgM kappa concentration in human serum.  The result is to be used with previously diagnosed igm Waldenstoms Macrolobulinaemia, in conjunction with other clinical and laboratory findings.
Kit is composed of polyclonal monospecific sheep anti-IgM kappa antibody, IgM kappa Calibrator, 2 IgM kappa Controls, and IgM kappa Supplementary Reagent
Immunoglobulin M Lambda Heavy And Light Chain Combined
Intended for the in-vitro quantification of IgM lambda concentration in human serum.  The result is to be used with previously diagnosed IgM Waldenstoms Macrolobulinaemia, in conjunction with other clinical and laboratory findings.
Kit is composed of polyclonal monospecific sheep anti-IgM lambda antibody, IgM lambda Calibrator, 2 IgM lambda Controls, and IgM lambda Supplementary Reagent
Electrosurgical Vessel And/Or Tissue Sealer. With Built-In Generator.
Intended for any procedure where vessel ligation (cutting and sealing), soft tissue grasping and dissection are performed.
Applicator/Dissector, RF Generator and Battery are integrated in a single handpiece.
Application of RF energy to heat and seal vessel/tissue followed by dissection of target vessel/tissue.
Has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures.
Is intended to be used as an adjunct to neonatal phototherapy systems used for the treatment of neonatal hyperbilirubinemia in the clinical or home setting.
Comprised of a light-weight, spun bond polypropylene material. Spun bond polypropylene is a commonly used fabric in medical products and garments. The material is non-irritating to the skin, soft, and allows it to easily conform to body contour
Comprised of a light-weight, spun bond polypropylene material. The blanket is intended to allow an infant undergoing phototherapy for hyperbilirubinemia to be tightly swaddled and still receive the full benefit of the phototherapy treatment. Th
Relief of symptoms of clinically diagnosed dialysis-related amyloidosis (DRA).
The Beta 2-microglobulin Apheresis Column is an adsorbent column containing porous, spherical cellulose beads with covalently linked hexadecyl groups as ligands.  The size of the pores on the beads is about 460 um.  The device comes in multiple
The device adsorbs Beta 2-microglobulin by the combined use of hydrophobic interaction and the appropriate pore size on cellulose beads.  The pore size limits the size of proteins and peptides adsorbed by the column to be between 4 and 20 kDa.
Quantitative determination of Hemoglobin A1c to aid in the diagnosis of diabetes.
In-Vitro Diagnostic for use with Whole blood
Early Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Characterization
The EGR1 FISH Probe Kit for specimen characterization  detects the LSI EGR1 probe target on chromosome 5q in bone marrow specimens.  This assay is used to characterize bone marrow specimens from patients with acute myeloid leukemia (AML) or mye
May include LSI EGR1 DNA probes, hybridization buffers, DAPI counterstain
Bone marrow cells from AML patients attached to microscope slides using standard cytogenetic procedures are used for this assay.  The resulting specimen DNA is denatured to single-stranded form and subsequently allowed to hybridize with the LSI
To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery.
A user interface/control unit; handpiece with tip to deliver the electric current; and a separate monitoring electrode if detection is not built in the same tip.
Sends out electrical current, monitors for this current, and informs user of a change from baseline.
Computer assisted system to administer a drug and control depth of sedation and provide monitoring and alarms for physiological vital signs and other parameters of sedation.
Computer controlled infusion pump, multi-parameter physiological monitoring, negative feedback control system algorithm.
Computer assisted drug administration using feedback from patient physiological parameters.
Central nervous system, cardiopulmonary system.
To detect specified amniotic fluid proteins in cervicovaginal samples
Detects specified amniotic fluid proteins
To facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including subchronic and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention, such as angioplasty, ather
Creates narrow channel in occlusion to allow for guidewire placement for further percutaneous intervention, such as angioplasty, atherectomy or stent placement.
An internal tissue marker is a prescription use device that is intended for use prior to or during general surgical procedures to demarcate selected sites on internal tissues.
A biocompatible dye that is applied to the target tissue using a soft tipped marker.
Organs, veins, arteries and other internal tissues.
Flow cytometer calibrators are polystyrene or other particles whose defined characteristics (e.g. number, size, scatter or fluorescence intensity) is used to standardize instrumentation or to quantify other particles or analytes measured by flo
Beads for performing absolute counts of cells in suspension by flow cytometry  Beads for standardizing flow cytometers  Beads that are used to calibrate fluorescence intensity to quantify ligand binding or fluorogenic assays performed by flow c
Bead associated fluorescence or scattered light is used to determine the number of other particles in solution ratio-metrically and to calibrate fluorescence intensity scales on a flow cytometer to standardize measures.
For the quantitation of specific organophosphate metabolites in human urine from individuals who have signs and symptoms consistent with cholinesterase poisoning.  The data obtained by this device is intended to aid in the confirmation and inve
solid-phase extraction cartridge, mass spectrometer, HPLC
Urine is diluted in acetonitrile and separated using normal phase solid-phase extraction which is further concentrated  so that the analytes can be ionized via mass spectrometry.
Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
For the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T mentagrophytes, and/or yeasts Candida albicans, etc.).
Laser device outputting energy at different wavelengths
Laser energy delivered to the target area by scanning
Toe nail of the patients with onychomycosis
Endoscope, Accessories, Image Post-Processing For Color Enhancement
Alternative mode of visualization using image post-processing algorithms of the received white light image for color enhancement.
The system consists of flexible and/or rigid scope(s), light source(s), video processor and display.
Image enhancement using image post-processing algorithms of the received white light image with the goal of enhancing visualization of suspicious images seen on white light.
Limited to endoscopic systems for observation of the gastro-urological tract.
Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible
A personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of sexual activity and supplement the body's natural lubrication.  This device may or may not be compatible with
Coats vaginal and/or penile tissue to reduce friction during sexual activity with or without a condom; is non-toxic to sperm, oocytes, and developing embryos and does not interfere with the fertilization process; lubricates devices used during
Provides automated loading and unloading of instruments requiring sterilization for increasing hospital work flow efficiencies. The system consists of a user interface, loading conveyor, load transport shuttles, unloading conveyor to be used as
The system consists of a single point user interface station, loading conveyor, load transport shuttles, unloading conveyor and a sterilizer that sits on a loading car.
Works in conjunction with a steam sterilizer
The heparin flush in 0.45% sodium chloride is intended to maintain patency of an indwelling intravenous catheter device designed for intermittent injection or infusion therapy or blood sampling.  It provides an alternative to clinicians to prev
Transparent container, volume markings on the syringe barrel, tip cap, plunger stopper and Heparin Lock Flush solution
Attaach syringe to access device and flush.
Heparin lock device or central venous catheter.
A nucleic acid quantitation kit consists of a nucleic acid stain (e.g., fluorescent, colorimetric, etc.) which is used to detect and quantitate small amounts of DNA, RNA, or oligonucleotides in solution by measuring the amount of fluorescence o
The device consists of a complete reagent kit or accessory nucleic acid dye reagents intended to be used together.
A complete kit or accessory dye reagents which are intended and designed to bind to DNA (single- or double-stranded), RNA, or oligonucleotides depending upon the type of dye utilized.  The stained nucleic acid is measured using a spectrophotome
For use in hemodialysis catheters to reduce hub infection.
Antimicrobial agent adhered to rod and lock ring of end cap. End cap has a rod which extends into the hub of the hemodialysis catheter to aid in delivering antimicrobial agent
To detect and measure salivary estriol in pregnant women.
A posterior, non-pedicle supplemental fixation device intended for single level use in the non-cervical spine (T1-S1).  It is intended for single level plate fixation/attachment to spinous process for the purpose of achieving supplemental fusio
Plates with teeth/spikes and crossbar/tray/bumper that connects and locks plates together, metallic, metallic and polymer combination
Placed between two spinous processes to immobilize the segment, provide supplemental stabilization, and to facilitate fusion at the treated level
Intended to serve as a disposable  barrier for dental instruments to reduce  the risk of cross contamination between dental patients.
Adhesively applied to patient contacting surfaces of reusable dental instruments/devices.
For devices to be used in dental surgery.
Gram-Negative Bacteria And Associated Resistance Markers
A qualitative multiplexed in vitro diagnostic device to detect and identify gram-negative bacteria and resistance markers in positive blood cultures.
Fungal Organisms, Nucleic Acid-Based Assay
A qualitative multiplexed in vitro diagnostic device to detect and identify fungal organisms in positive blood cultures.
Molecular determination of allelic variants that indicate erythrocyte antigen phenotypes
Accessories that attach to the light and assist in magnifying, clarifying, enhancing the image being viewed.
Uses Lens to improve the image of the surface area being viewed under the light.
Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis
Flow cytometer specimen processors are automated or semi-automated workstations designed to be used alone or in combination with manual methods to pipette, dilute and process human specimens in preparation for flow cytometric analysis.
May include automated processing devices, pipetting devices, diluting devices.
Workstations prepare human specimens for flow cytometric analysis using an automated process to aspirate and dispense whole blood, lysing, stabilizing and fixative reagents, along with monoclonal antibodies and florescent molecules.
May include peripheral whole blood specimens, isolated mononuclear cells, bone marrow, body fluids and cells dispersed from tissues.
Ro60 assays are designed for the determination of IgG anti-Ro60 (SS-A Ro60) autoantibodies in human serum.  The presence of anti-Ro60 autoantibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis o
Consist of components/reagents to   detect and semi-quantitatively measure autoantibodies to SS-A 52.
The assay is performed by testing human serum or   plasma.
System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen
The [test] is intended for use with specimens from patients for whom there is clinical suspicion of tuberculosis (TB) and who have received no antituberculosis therapy, or less than 3 days of therapy. This [test] is intended as an aid in the di
Nested real-time PCR.  The [test] must be used in conjunction with mycobacterial culture to address the risk of false negative results and to recover the organisms for further characterization and drug susceptibility testing.    The [test] shou
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enfo
Implantable Transprostatic Tissue Retractor System
The treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men age 50 and above.
Comprises two main components, the delivery device and implant. Each delivery device comes pre-loaded with one I\implant. The delivery device is inserted into a 20F cystoscopy sheath which has been placed in the male urethra with the sheath tip
Delivered transurethrally using a rigid delivery device which is used to displace the urethra towards the prostatic capsule. The implants then maintain the approximated position of the inner (urethral) tissue and the outer (capsular) tissue of
System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
A mass spectrometer system using matrix-assisted laser desorption/ ionization - time of flight (MALDI-TOF) for the identification of microorganisms cultured from human specimens.
Matrix-assisted laser desorption/ionization - time of flight (MALDI-TOF) mass spectrometry
Identification of microorganisms cultured from human specimens
Central Venous Catheter Dressing Change Kit
Measures the central venous blood pressure (CVP) non-invasively at the superior vena cava (right heart) based on near infrared spectroscopy (NIRS) technology.
display unit, sensor cable, and adhesive sensor patches
Uses near infrared spectroscopy (NIRS) technology to measure blood flow between the neck location and the reference location
Allogeneic skin cells cultured in vitro and combined with scaffold sheeting to act as a physical wound covering and provide biological components that interact with the wound, for treatment of skin ulcers.
Allogeneic skin cells are cultured in vitro and combined with scaffold sheeting
Device funtions as a physical wound covering and provides biological components that interact with the wound
for the treatment of type 2 diabetes. The gastrointestinal liner is indicated for a maximum of 12 months.
It is provided sterile and consists of a gastrointestinal liner (anchor and liner), preloaded in a catheter that delivers the liner to the proximal intestine.
A high throughput sequencing technology performing targeted DNA sequencing of amplicons from a defined genetic region or a subset of genes in human genomic DNA from a clinical sample.
sequencing instrument and associated software
A high throughput DNA sequence analyzer is an automated clinical multiplex instrument system intended to prepare, generate, measure and sort signals in order to analyze DNA molecules of amplicons from a clinical sample such as peripheral whole
human genomic DNA from a clinical sample
Dna Fish Probe Kit For Specimen Characterization, Human Chromosome, Hematological Disorders
DNA FISH probe kits for specimen characterization detect DNA probe targets on human chromosomes in bone marrow and peripheral blood specimens.
DNA probes labeled with fluorescent dyes, hybridization buffers, counterstain
Cells from bone marrow or peripheral blood are obtained from a patient with a hematological disorder. Cells are attached to microscope slides using standard cytogenetic procedures. The resulting specimen DNA is denatured to single-stranded form
Bone marrow and/or peripheral blood specimens
For use as an access device accessory on arteriovenous fistulas (AVF) for hemodialysis procedures using a constant site or buttonhole method of needle insertion.
It is comprised of a port or septum that permits passage of a needle.
Implanted and attached to a vessel, permitting guide for insertion of a needle into the vessel.
Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor
Mechanical dilation of the cervical canal for labor.
Use mechanical force to dilate cervix to prepare for vaginal delivery.
Quality Control For Molecular Immunohematology Tests
The quality control for molecular immunohematology assay is used to demonstrate that the test can correctly detect genetic variations of human erythrocyte antigens.
Intended to provide a soft barrier between wired mouth hardware and oral mucosa.
Uses non-latex foam to cover wired mouth hardware. Foam is frictionally retained by a slit in its center.
intraoral between metal appliance on teeth and lip or cheek.
Non-fusion growth modulation of spinal column.
Metallic plate or staple with fixation elements
An antero-lateral growth plate intended to attach to vertebral bodies in order to modulate growth of the spinal column
The main components of the device include implanted leads (depth and cortical), implanted neurostimulator, and external programmers.
Uses an implanted neurostimulator to sense ECoG activity and provide stimulation to depth and/or cortical leads.
Management of closed hyperproliferative (hypertrophic and keloid) scars.
Silicone oil containing hydrogel with preservative identified by the Center for Drug Evaluation and Research (CDER) as an inactive ingredient.
Product forms a protective film that helps maintain skin hydration.
A visual, qualitative immunoassay for the in vitro detection of elevated levels of the MMP-9 protein in tear fluid from patients suspected of having dry eye.
Tear collection method and single use immunoassay test cartridge
System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection
The CFTR gene mutation detection system is used to simultaneously detect and identify a specified panel of mutations and variants in the CFTR gene using sequencing methods. It is intended for carrier screening, as an aid in confirmatory diagnos
Multiplex qualitative amplification based test system.  The device may include a use for newborn screening. Should not include devices using non-sequencing based detection methods.
The assay uses multiplex polymerase chain reaction to amplify and identify a specific panel of DNA variants located on the CFTR gene with DNA sequencing based detection methods.  Variants are identified by comparison to a specified reference se
Human peripheral whole blood or clinical samples
System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection
The CFTR gene variant detection system is used to sequence specified regions of the CFTR gene to detect gene variants. It is intended as an aid in confirmatory diagnostic testing of individuals with suspected cystic fibrosis (CF), those with at
Multiplex qualitative amplification with DNA sequencing detection methods. Should not include devices using non-sequencing based detection methods.
Uses multiplex polymerase chain reaction to amplify and sequence specific regions of the CFTR gene with DNA sequencing based detection method. Variants are identified by comparison to a specified reference sequence.
Reagents For Molecular Diagnostic Test Systems
A kit that is a set of reagents and consumables used in the processing of human genomic DNA samples derived from peripheral whole blood, and in the subsequent targeted re-sequencing of the resulting sample libraries. User-supplied analyte speci
System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
An endovascular graft for AV dialysis access is a stent graft intended for the revision of arteriovenous access circuits to maintain or re-establish vascular access (treat stenotic lesions or thromboic occlusions) for hemodialysis.
The endovascular stent-graft is a metal scaffold covered with fabric material.  The stent-graft is placed via a delivery catheter into the arteriovenous dialysis access circuit to maintain or re-establish vessel patency for hemodialysis.  The e
Generally, a Peripheral Transluminal Angioplasty (PTA) catheter is used initially to open up the occlusion and allow for passage of the endovascular graft delivery system to pass through.  The endovascular graft is then deployed at the site of
Stenotic lesions or thrombotic occlusions in the arteriovenous dialysis access circuit, including the venous anastomosis.
System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection
A microarray-based, genome-wide, postnatal chromosomal abnormality detection system is used to qualitatively detect constitutional gains and losses in chromosomal copy numbers across the human genome using microarray methods.  It is intended as
The test system consists of a multiplex qualitative amplification based test system which may utilize different types of microarrays and/or probes to represent the whole genome.  The device may integrate scanning, reagent handling, hybridizatio
The test system uses amplification of extracted genomic DNA followed by hybridization of the amplified, labeled fragments to homologous probes on a microarray.  The system uses signal intensities from the bound probes as the basis for determina
For non-continuous central monitoring of patient parameters, including cardiac parameters, in low risk patients.
Electronic display at a central monitoring station of monitoring data from patient sensors.
involves cardiac sensing and other sensor locations on the body
An ophthalmic sealant is intended to maintain an incision closure and aid in preventing fluid egress from incisions in the eye.
A topical liquid/hydrogel/material which creates a temporary adherent closure.
An ophthalmic sealant device is applied to an incision in the eye following an intraocular surgery. Once applied to the surface of the eye, the device adheres to the ocular tissue and aids in incision closure and prevention of fluid egress.
visualization of the colon for the detection of polyps
The device is a single-use ingestible capsule designed to acquire video images during natural propulsion through the digestive system. It is specifically designed to visualize the complex anatomy of the colon
Gastric emptying breath tests are intended for use in the measurement of the rate of gastric emptying of solids and as an aid in the diagnosis of delayed gastric emptying (gastroparesis) in adult humans who are symptomatic for gastoparesis.The
test kit, mass spectrometerSystem, 13C-labeled test meal, and associated software
Baseline breath samples are collected prior to the administration of test meal.  After an overnight fast, the patient consumes a 13C-labeled test meal and post-meal breath samples are collected at multiple time points after meal ingestion.  As
For thawing red cells prior to transfusion.
may be of various shape; can be metal or platic or a combination of metal and plastic
For thawing frozen plasma prior to transfusion.
various shapes, may be composed of metal and plastic
Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel
Intended for the qualitative detection and differentiation of HSV-1 and HSV-2 in cerebrospinal fluid (CSF) from patients with signs and symptoms of Herpes Simplex Virus (HSV) central nervous system (CNS) infection.  This test is an aid in the d
Real-time Polymerase Chain Reaction Assay
Not Applicable, the device is an In vitro diagnostic device
Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
For the qualitative detection and differentiation of VZV, HSV1, HSV2- DNA in cutaneous and mucocutaneous lesion samples from symptomatic patients. The assay is not intended for use with cerebral spinal fluid.
Not Applicable. In vitro diagnostic device
Pulse oximeter intended for wellness use.
Used to transmit light at known wavelengths(s) through blood using a light emitting diode(s) and sensor.
Transmit light at a known wavelength(s) through blood to measure photoplethysmographic data based on the amount of reflected or scattered light.
Cannula, Injector, Uterine, Endometrial Biopsy
to deliver saline and/or contrast media to complete saline infusion sonohysterography and/or hysterosalpingogram respectively and to obtain endometrial biopsy
cannula that allows injection of saline and/or contrast media and component that collects an endometrial biopsy sample
inserted manually through the vagina and cervix and into the uterus; delivers saline and/or contrast media into the uterus and fallopian tubes, collects endometrial biopsy sample
Stabilization or correction of spinal deformities without the use of fusion.
Metalllic rods, monoaxial or polyaxial bone screws, hooks, and other related accessories.
The system of distracting or compressing rods and fixation elements (screws, hooks, etc.) provides stabilization and correction of the spine as the child grows.
Stabilization or correction of spinal deformities without the use of fusion, using non-invasive methods to adjust the spinal rod.
Metalllic rods, monoaxial or polyaxial bone screws, hooks, magnetic remote control, and other related accessories.
The system of distracting rods and fixation elements (screws, hooks, etc.) provides stabilization of severe spinal abnormalities and distraction of the rod as the child grows, via magnetic actuation.
Single use devices that are indicated for use as an accessory with sterile 1ML long staked needle prefilled ISO standard glass syringes to aid in the protection of healthcare professionals, patients who self-inject, doctor prescribed medication
Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification
Intended to provide electric stimulation to the mid to high frequency region of the cochlea and acoustic amplification to the low frequency regions, for patients with residual low frequency hearing sensitivity.
external sound processor, implant  (w/ receiver/stimulator and electrode array), programming software, accessories
provide electric stimulation to the mid- to high frequency region of the cochlea via implant and acoustic amplification to the low frequency regions via an external component
Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar
to distend the uterus with saline and maintain distension through closed-loop recirculation of filtered distension fluid during diagnostic and operative hysteroscopy.  It is also intended for cutting and coagulation of uterine tissue.
controller that provides bipolar frequency and fluid management through the use of two peristaltic pumps.  Bipolar frequency is delivered to a bipolar electrosurgical resection device.  Fluid management is provided via infusion/aspiration throu
a closed-loop system with a preset volume of saline available for use during hysteroscopy.  Fluid is continuously recirculated by pumps from a 3L saline bag, into the uterus, through a tissue trap and a filter and then back to the bag.  Cutting
Spatial Imaging For Display Of Endoscope Position
To detect and display the shape of an inserted endoscope.
A control unit that communicates with an endoscope/accessory probe, a receiver dish, and display monitor.
Measures electromagnetic fields from the endoscope or an accessory within an endoscope to determine the shape of an inserted endoscope, and displays it on a monitor.
The test system is intended for the qualitative determination of IgG class autoantibodies against phospholipase A2 receptor (PLA2R) in human serum. It is used as an aid in the diagnosis of primary membranous glomerulonephritis (pMGN), in conjun
slides coated with cells, fluorescein-labelled detection antibody, positive and negative controls, buffers, embedding medium, cover glasses
Ear, Nose, And Throat Stereotaxic Instrument
Intended as an aid for precisely locating a surgical instrument within anatomical structures in either open or percutaneous procedures for any medical condition in which a reference to a rigid anatomical structure in the field of ENT surgery ca
Navigation computing platform with navigation software, providing interfaces for screen and input devices including a navigation sensor, a navigation instrument and a patient reference localizer.
The device measures the position of the surgical instrument and the position of the patient using a position measurement sensor.
Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
An in vitro diagnostic test for the detection of Group A, C and G beta hemolytic Streptococcus in throat swab specimens from symptomatic patients.
Uses nucleic acid amplification technology to detect Groups A, C and G Sreptococci
Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use
To control bleeding in junctional, non-compressible wounds until surgical care is acquired.
Sterile, non-absorbable, radiopaque, expandable sponges that may include a delivery device.
The sponges expand upon contact with blood to fill the wound cavity and provide pressure and a physical barrier that facilitates formation of a clot. The temporary sponges are completely removed from the wound during surgery prior to closure.
Junctional, non-compressible wounds in the groin or axilla not amenable to tourniquet application. It is NOT indicated for use in the following areas: thorax; pleural cavity; mediastinum; abdomen; retroperitoneal space; sacral space above the i
Infusion safety management software is a prescription device intended for use with infusion pumps and may include one or more of the following capabilities: prepopulation of infusion programming parameters, data retrieval and analysis for track
The device is a software application(s), which may be implemented as part of an infusion pump and may also be implemented onto a hospital information system for use with an infusion pump system.
Infusion safety management software may include one or more software applications that enforce safety control mechanisms through wireless or wired communication between the hospital information system, the infusion pump, and the healthcare prov
Target area is according to the approved drug or biologic product labeling.
The Zinc Transporter 8 Autoantibody (ZnT8Ab) ELISA Assay is for the semi-quantitative determination of autoantibodies to Zinc Transporter 8 (ZnT8) in human serum. The KRONUS Zinc Transporter 8 Autoantibody (ZnT8Ab) ELISA Assay may be useful as
Assay Kit includes strip wells coated with ZnT8; 4 level calibrators; positive and negative controls; Zinc biotin; buffer; streptavidin peroxide; diluent; peroxide substrate; wash solution; stop solution
a digital polymerase chain reaction system intended to measure and sort multiple signals generated in an In Vitro Diagnostic assay from a clinical sample.  This instrumentation is used with a specific assay to measure multiple similar analytes
System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations
A multiplex genotying test system intended for the qualitative detection and identification of specific thrombophilia related gene mutations from genomic DNA by genomic amplification and mass spectrometry.  It is intended as an aid in diagnosis
A qualitative multiplex amplification-based genotyping test system.  Should not include any devices other than mass spectrometry-based detection systems.
The assay uses multiplex polymerase chain reaction and allele specific single base primer extension reactions to amplify and detect specific mutations located in the Factor V and prothrombin genes.  Genotyped products are resolved according to
Human peripheral whole blood or other clinical samples.
Test, Cell Mediated Immune Response, Liver And Small Bowel Transplant/Transplantation
The test is a qualitative prognostic test intended to be used in patients less than 21 years old with liver or small bowel transplantation. The test is an aid in the evaluation of the risk of acute cellular rejection (ACR) and must be used in c
flow cytometers, fluorochrome labeled antibodies, sodium heparin blood collection tubes, processing reagents, automated processing devices or pipetting devices.
A powered exoskeleton is a prescription device that is composed of an external, powered, motorized orthosis used for medical purposes that is placed over a person's paralyzed or weakened limbs for the purpose of providing ambulation.
The device is a wearable exoskeleton device that allows the user to enable ambulation over the course of the day.  The control of the device is achieved through a wrist-worn user-operated wireless communicator, tilt sensor and specific body mov
The movement of the swing leg is controlled by a seat of gears and DC motors at the knee and hip joints.  Minimizing energy expenditure with gait approximation is critical for maximizing battery life between charges.
The device legs consist of left and right interconnect hip and knee segments.  Multiple attachment straps are mounted along the length of each leg.  The pelvic band support provides a structure to join the two legs together and the pelvic strap
Intervertebral Fusion Device With Bone Graft, Thoracic
Intended to stabilize thoracic spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
Protective Coating, Mucoadhesive Application, For The Rectal Mucosa
Mucoadhesive application for the protective coating of the rectal mucosa.
applied via enema bottle applicator, the mucoadhesive formulation results in the formation of a protective coating over the rectal mucosa.
Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs
Preservation of donor lungs for transplantation.
Device consists of a system made up of several components, such as the oxygenator, ventilator, thermal control unit, flow pumps, as well as the dedicated disposable sets, cannulation accessories, organ chamber and STEEN preservation solution.
Device actively perfuses the donor lung with a preservation solution, while also ventilating and oxygenating it, and while maintaining it in near-physiologic temperatures, so that it may be preserved and assessed for transplantation.
Anterior Staple As Supplemental Fixation For Fusion
Anterior cervical device for supplemental fixation to support a fusion.
This is a metalic staple that is implanted into two adjacent vertebral bodies.
The staple provides physical support while a fusion develops between vertebral bodies.
This is intended for the anterior, cervical spinal column in skeletally mature patients.
Diammine Silver Fluoride Dental Hypersensitivity Varnish
Applied to tooth enamel to block dentinal tubules for the purpose of reducing tooth sensitivity.
precipitates upon application resulting in a physical blockage of dentinal tubules
To assist in maintaining an open airway.
Consists of Fortiflex B53-35H--1 1, High Density Polyethylene and is to be used with a latex strap.
To be placed in the mouth and increase the pharyngeal airspace.
To allow endoscopes to soak in reprocessing solutions.
The device is comprised of a basin that may be molded to more closely meet the contours of a coiled endoscope. The device may include a heater and temperature monitor.
The basin may be contoured to minimize the volume of reprocessing solution used. The basin may also have a temperature control. The basin does not include flushing technology.
Abdominal intracompartmental pressure monitoring using bladder pressure as a surrogate for abdominal pressure.
Urological catheter, pressure sensing device.
Monitoring abdominal intracompartmental pressure with a urological catheter
Continuous Glucose Monitor Retrospective Data Analysis Software
Continuous glucose monitor retrospective data analysis software is intended to analyze and correlate retrospective data from a continuous glucose monitoring device.
Intended to be used to relieve pain and to replace the glenoid and humeral side of the shoulder joint in order to restore mobility in a grossly rotator cuff deficient joint with severe arthropathy or a previous joint replacement with a grossly
Typically includes humeral stem, humeral socket, humeral cup, glenosphere, and glenoid baseplate with fixation screws.  The humeral stem and humeral socket may be one single piece or two separate pieces locked together.  The humeral cup is snap
Relative to the native shoulder joint, the device moves the center of rotation medially and distally to the anatomic position which increases the length of the deltoid muscle's lever arm, allowing the same rotational moment with less applied fo
Sparse Sample Pk Profile And Dosing Software
To estimate PK profile and dosing calculation.
The device is intended to measure abnormal breath sound, such as wheeze, rhonchi, and whistling.
It is a hand-held electronic measurement device that utilizes  an acoustic sensor to acquire, amplify, filter, record and analyze pulmonary sounds from the trachea for the presence of breath sounds such as wheeze.
Vibrator For Climax Control Of Premature Ejaculation
Vibrator for climax control training for the treatment of premature ejaculation.
The device consists of a vibrator connected to a battery pack.
Battery-operated vibrator and lubricant for climax control of premature ejaculation for men
To use as an oral electronic vision aid in conjunction with other assistive devices (e.g., the white cane, guide dog, etc.)
headset (camera, glasses), intra-oral electrode array, battery, cable, software package
Translates images of objects captured by a digital camera into electro-tactile signals that are presented to the user's tongue.
Esophageal Dilator Balloon With Or Without Electrode Sensors
To dilate the lower esophageal sphincter of patients with Achalasia.
Tube and Balloon with or without electrode sensors and software.
Tube and Balloon with or without electrode sensors.
Esophageal Dilator With Balloon And Electrode Sensors
To dilate esophageal strictures with a dilating balloon and electrode sensors.
balloon with electrode sensors and software
Gastrointestinal Tubes With Enteral Specific Connectors
To facilitate enteral specific connections.
The connector is attached to an enteral tube and is intended to facilitate the administration of hydration, medication, and feed to a patient.
An acute kidney injury test system is intended to measure one or more analytes in human samples as an aid in the assessment of a patient's risk for developing acute kidney injury.  Test results are intended to be used in conjunction with other
The test system may include clinical analyzers, reagents, calibrators, and controls.
Assay to measure analyte(s) that are markers of Acute Kidney Injury
The test system is an in vitro diagnostic device that measures human samples.
Urethral Insert With Pump For Bladder Drainage
The device is intended to empty urine from the bladder under patient control.
A catheter-like device with internal pump mechanism that is placed in the urethra.
Under patient control, the internal pump inside the urethral insert draws urine out of the bladder when voiding is desired, and blocks urine flow when continence is desired.
Candida Species Nucleic Acid Detection System
The Candida species nucleic acid detection system is a qualitative panel for the direct detection of Candida species in whole blood specimens from patients with symptoms of, or medical conditions predisposing the patients to, invasive fungal in
The Candida species nucleic acid detection system consists of reagents and disposables and accompanying positive and negative controls.  The associated instrumentation performs the amplification of the Candida nucleic acid, detects the amplifie
A multiplexed nucleic acid amplification assay that amplifies and detects Candida DNA in whole blood specimens.
Reinforcement of soft tissue where weakness exists.
An acellular, sterile, non-pyrogenic porcine dermal matrix . The graft is packed dry and must be hydrated in sterile saline prior to use. The thickness of the device is 1.5 to 2.3mm.     The device surfaces are coated with an antimicrobial coat
Used to reinforce soft tissue defects, e.g., hernias, etc...
The device treats type 2 diabetes through hepatic nerve denervation. The metabolic neuromodulation system consists of a monopolar single electrode ablation catheter and radio frequency generator and is intended to ablate the sympathetic nerves
a qualitative in vitro diagnostic device intended as an adjunct for the detection of periprosthetic joint infection (PJI) in synovial fluid of patients experiencing pain and/or inflammation in a replacement joint.
Weight reduction by peripheral neuromodulation.
Neural modulation with implantable electrical pulse generators.
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080216.htm.
Facilitates enteral specific connections between AAMI/CN3(PS):2014 compliant connectors and non ISO 80369-1 compliant legacy enteral connectors.
A plastic connector that allows for AAMI/CN3(PS):2014 compliant connectors to connect to non ISO 80369-1 compliant legacy enteral connectors.
An air polishing powder to be used with an airbrush for prophylaxis in the oral cavity.
The powder is dispensed via an electric airbrush and removes plaque via abrasion of the tooth surface by the powder granules.
Reagents For Detection Of Norovirus Nucleic Acid
Qualitative in vitro diagnostic test for the rapid detection and differentiation of norovirus genogroup I and genogroup II from specimens e.g., stool collected from individuals with symptoms of acute gastroenteritis.
The device/system consists of an instrument, personal computer, and preloaded software for running the tests and viewing the results.
Instrument Systems automate and integrate sample preparation, nucleic acid  extraction and amplification, and detection of the target sequences in simple or complex samples using reverse transcriptase PCR (RT-PCR) and real-time PCR assays.
The Mercy TAPE device (2D and 3D models) is intended for use by health care professionals to estimate the body weight of pediatric patients between the ages of 2 months and 16 years, using linear measurements from specific anatomical landmarks
The Mercy TAPE device consists of semi-durable or disposable flexible strips of coated paper, fabric or plastic tape printed with numbered bins proportional to fractional body weight of pediatric patients.
The 2D and 3D Mercy TAPE device combines the physical properties of the simple tape measure, with the intended use of the Stand-on patient scale and patient scale, which is estimation of body weight. TAPE performs this function based on an algo
for humeral length (HL, for the 2D model) or half-humeral length (HHL, for the 3D model) and the mid-upper arm circumference (MUAC).
An in vitro diagnostic test for the detection of Leishmania spp. antigens to aid in the diagnosis of Leishmania spp. infection.
May include immunochromatographic assays,  enzyme linked immunoassays, or other in vitro diagnostic methods to detect antigens from Leishmania spp.
Clinical specimens from patients suspected of infection with Leishmania spp.
Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use
Automated system consisting of a fluorescence microscope and software that acquires, analyzes, stores and displays digital images of stained indirect immunofluorescent slides.  It is intended as an aid in the detection and classification of cer
The system may include a fluorescence microscope with light source, a motorized microscope stage, dedicated instrument controls, a camera, a computer, a sample processor, and other hardware components.  The software may include fluorescent sign
Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid
A prescription device that uses a patient's electroencephalograph (EEG) to provide an interpretation of the structural condition of the patient's brain in the setting of trauma.  The Brain Injury Adjunctive Interpretive EEG Assessment Aid is fo
Handheld EEG recording device, electrodes, and data analysis software
Elbow Joint Metal/Polymer, Constrained, Porous Coated, Uncemented Prosthesis
An elbow joint metal/polymer constrained uncemented prosthesis is a device intended to be implanted to replace an elbow joint.
The components have a porous coating made of Ti-6Al-4V alloy powder. The coating is further enhanced by a layer of hydroxyapatite.
The device prevents dislocation in more than one anatomic plane and consists of two components that are linked together. It is designed to achieve biological fixation to bone without the use of bone cement.
Stainless Steel Instrument, Shunt System Implantation
A stainless steel shunt system implantation instrument is an instrument made entirely of stainless steel used in the implantation of cerebrospinal fluid shunts, and includes tunneling instruments for passing shunt components under the skin.
The device is used as an instrument to place cerebrospinal fluid shunts.
Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve
Intended for use as a CPR adjunct to improve the likelihood of survival in adult patients with non-traumatic cardiac arrest.
The device system is comprised of two components:  A manual pump containing a suction cup so that active decompression can take place.  The valve is inserted in the respiratory circuit (e.g., facemask or advanced airway) during CPR.
Uses active compression and decompression of the victim's chest during manual CPR, as well as impeding the inflow of air during the decompression phase to reduce the intrathoracic pressure and increase blood flow.
The pump is placed on the victim's chest, and the valve is placed within the respiratory circuit.
Coronary Vascular Physiologic Simulation Software
A coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease.
Performs offline analysis of pre-existing imaging data to simulate blood flow in the coronary vasculature.
A steerable cardiac ablation catheter remote control system is a device that is external to the body and interacts with the manual handle of a steerable cardiac ablation catheter to remotely control the advancement, retraction, rotation, and de
Consists of non-sterile, reusable components including the remote catheter system (sled, track, and turret), a hard-wired remote control, a bridge support with rail and frame, as well as a sterile, single use docking station and spreader to int
Uses electronic stepper motors to operate the manual handle of a steerable cardiac ablation catheter to remotely control its advancement, retraction, rotation, and deflection.  The system does not use software or decision logic to control the c
Newborn Screening Specimen Collection Paper
Newborn screening specimen collection paper is a blood collection device intended to be used as medium to collect and transport whole blood specimens from newborns to the laboratory for in vitro diagnostic analysis.
Newborn screening specimen collection paper is an in vitro diagnostic device that consists of specifically designed filter paper with a uniform surface for the collection of blood spots.   The collection paper is in the format of a printed card
The blood is applied to the indicated spots on the paper.  The specimen is allowed to dry and then sent to a laboratory for in vitro diagnostic analysis.
An in vitro diagnostic device used as a medium to collect and transport whole blood specimen spots to a laboratory
Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device
Intended for use in the collection, preservation, and transport of oral fluid specimens for drugs of  abuse or alcohol  testing.
Specimen collection device, which may include an absorbent oral fluid collection pad and/or a specimen storage container for collection, preservation and transport.
Collects oral fluid and stabilizes it for transport or storage.
Blood/Plasma Collection Device For Dna Testing
A blood collection device for DNA testing is an in vitro diagnostics device intended to collect and transport blood specimens to the laboratory for clinical DNA testing.
The blood is drawn in the tube to be transported to the laboratory for clinical DNA testing.
Whole blood/ plasma for in vitro diagnostics
Preparation and storage of pathogen-reduced, blood components.
chemical treatment with UVA illumination
Intended to treat fecal incontinence by controlling the size of the rectal lumen.
The device includes a balloon like device placed in the vagina and an external regulator and inflation pump to control the state of expansion.
The device is inserted in the vagina and includes a portion that expands to reduce the rectal lumen to prevent stool leakage and retracts to allow normal passage of stool.
Vaginal placement for compression of rectum
Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System
A newborn screening test for severe combined immunodeficiency (SCID) intended for the detection of T-cell receptor excision circle (TREC) genomic DNA isolated from newborn blood specimens dried on filter paper.  It is intended as an aid in scre
The test consists of primers and probes to amplify and detect genomic DNA obtained from newborn peripheral blood dried on filter paper.  The device includes reagents, instruments, software and consumables, and may integrate punching of a dried
The test system uses primers to amplify genomic DNA obtained from newborn peripheral blood dried on filter paper and probes to detect specific DNA targets of interest.
Intended for use in terminal sterilization of cleaned, rinsed, and dried metal and non-metal reusable medical devices in health care facilities.
The sterilizer is a dual sterilant sterilizer using hydrogen peroxide and ozone as the sterilant
Approximation of tissue layers where subcutaneous dead space exists between the tissue planes in abdominoplasty.
A surgical adhesive based on a polyurethane pre-polymer. In its pre-polymerized form, this is a viscous liquid. The primary component of the adhesive is created by reacting trimethylolpropane (TMP) with lysine di-isocyanate ethyl ester (LDI).
The liquid is applied drop-wise to the tissue surfaces to be adhered, and then the tissue surfaces are approximated for several minutes to allow the moisture in the tissue to initiate the curing process.  The applicator is a hand-held, disposab
Filler, Bone Void, Alterable Compound For Cranioplasty
An alterable cranial bone void filler is a device intended to be a bone substitute for the replacement of bony voids, defects, and contour irregularities in non-load bearing regions of the cranial skeleton, and are not intrinsic to the stabilit
The device is implanted in the bony void and may be secured using plates and screws to prevent the movement of the cranial bone void filler.
Filler, Bone Void, Nonalterable Compound For Cranioplasty
A nonalterable cranial bone void filler is a device that is created from patient-specific computerized tomography (CT) imaging data and intended to fill bony voids, defects, and contour irregularities in non-load bearing regions of the cranial
Manufactured as Patient-Specific Preformed Implant
Fall Prevention Alarm/Sensor Combination Attached Or Unattached
The fall-prevention alarm/sensor is a combination device that can attach to a person usually by a clip or belt OR it can be used unattached to the person, where the person sits upon it.
This fall prevention alarm  can be used two way. It can  attach to a person's body or clothing or it can be used unattached where the person sits upon the sensor pad as with devices cleared under product code KMI.
The alarm activates when weight is applied to the sensor changes or the magnet clip disconnects from the alarm. This alarm may be connected to the Nurse Call System. If the alarm is connected to the hospital's Nurse Call System, the  nurse call
Device  can be used two different ways: 1) attached to the person or 2) not attached to the person.   If used attached to the person, it can be applied to a person's clothing by use of the clip or it is worn around a person's waist via the belt
Fall Prevention Alarm/Sensor Attached Only
This  fall-prevention alarm/sensor works only when it is attached to a person.  It attaches to a person  usually by a clip or belt .
This fall prevention alarm  attaches to a person's body or clothing. A nurse call interface provides dual staff notification or enables the in-room alarm to be silenced.
The alarm activates when the clip (alarm cord) disconnects from the alarm. This alarm may be connected to the Nurse Call System. If the alarm is connected to the hospital's Nurse Call System, the  nurse call station signal activates.  This devi
The device can be used only when it is attached to the person.   If attached to the person, it is attached to a person's clothing by use of the clip or it is worn around a person's waist with the supplied belt.  It is not to be used on the head
The device is a polymerizing agent intended for permanent occlusion of peripheral blood vessels.
The device consists of a polymerizing glue and delivery system for injection into the vasculature.
The material polymerizes in the vessel to permanently coapt or occlude the vessel.
Stimulator, Electrical, Implanted, For Essential Tremor
Deep Brain Stimulation for the treatment of essential tremor
System components include implantable pulse generator, leads, extensions, patient programmer, and charger
Implantable pulse generator will produce electrical pulses which will stimulate deep brain structures through electrodes on leads.
Continuous Glucose Monitor Secondary Display
The purpose of the continuous glucose monitor secondary display is to notify another person, the follower, of the patient's continuous glucose monitoring system sensor glucose information in real time. The secondary display is intended for prov
Typically a software device installed on a third-party mobile device.
Receives and displays real-time patient data from a continuous glucose monitor.
The device is a percutaneous prosthetic device for the direct skeletal attachment of a prosthetic limb.
the device may be threaded, or coated to provide fixation to the bone. The device is made from medical grade mettalic components.
The device is implanted into the femur to allow a fixation point for standard prosthetic limbs.
An ophthalmic camera intended to capture and store images of the eye and surrounding area for prescription use only.
The device is a self-contained unit consisting of hardware (lens, camera sensor), software (capable of storing and basic processing), and a light source.
The images may be captured by use with or without mydriatic agents. The device makes use of a series of lenses to capture a clear, high-resolution, non-distorted image of the eye (e.g., retina). Light may be provided by sources such as LED, hal
The target area is the eye (lid, orbit) and ocular tissues (anterior and posterior segment).
External Upper Esophageal Sphincter (Ues) Compression Device
The external UES compression device is intended to reduce the symptoms of laryngopharyngeal reflux (LPR) disease by reducing the regurgitation of stomach contents from passing through the upper esophageal sphincter.
The external UES compression device consists of an externally worn band. The band typically consists of a cushion, a comfort band, a frame, comfort dial and clasp.
The external UES compression device is worn by the patient and is designed to provide a set pressure on the cricoid cartilage, which increases the luminal pressure within the upper esophageal sphincter (UES).
An upper esophageal sphincter (UES) compression device, which applies external pressure on the cricoid cartilage right below the Adam's apple.
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
Replacement of the humeral head for total anatomic shoulder arthroplasty
Short metallic humeral stem contained entirely within the metaphysis.
Humeral head is resected and canal is created to accept humeral stem component
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080216.htm
Bone Marrow Processing Device To Support Hematopoietic Reconstitution
Processing of bone marrow harvested from human donors to support hematopoietic reconstitution in a recipient.
May include centrifuge, pumps, valves, computerized safety/control systems, sterile single-use disposable tubing, and bags
Relies on a centrifugal field and may include filtration methods for separation of harvested bone marrow into its cellular and non-cellular components.
Bone marrow aspirates obtained from the iliac crest of human donors, processed and infused into the recipient's circulatory system
Fully Subcutaneous Implanted Hemodialyis Catheter
Provides access to the blood for hemodialysis or other chronic uses.
fully subcutaneous implanted hemodialysis catheter
Provides fully subcutaneous access to the blood for hemodialysis or other cronic uses.
internal jugular or femoral veins via the skin and subcutanous tissue
Used for dental crown restorations by single crown, bridge, etc, or for indirect repair of dental crown fabrications.
Used for dental crown restorations by single crown, bridge, etc, or for indirect repair of dental crown fabrications
Clip placement within the gastrointestinal (GI) tract for the purpose of endoscopic marking, hemostasis for mucosal/sub-mucosal defects, bleeding ulcers, arteries, polyps, diverticula in the colon, prophylactic clipping, anchoring feeding tubes
Metal clips applied by a delivery system
for in vitro diagnostic use in the quantitative measurement of hyaluronic acid in human serum.
When placed in the cervical canal, the device absorbs moisture, swells, and exerts radial pressure on the surrounding structures, resulting in mechanical dilation and promotion of cervical ripening.
Transparent Patch For Use In Treatment Of Tattoos
To reduce formation of bubbles during laser treatment of tattoos.
Liquid in a transparent double sided silicon patch
Uses a chemical optical clearing agent to interact with the bubbles as they are attempting to form to prevent this formation.
An Immunoglobulin G (IgG) Infusion System is a prescription device intended for subcutaneous delivery of Immunoglobulin G (IgG) in accordance with the FDA approved labeling.
An Immunoglobulin G (IgG) infusion system includes the delivery device, reservoir or syringe, and any administration sets and / or subcutaneous catheters or needles to infuse Immunoglobulin G (IgG) into subcutaneous tissue.
An Immunoglobulin G (IgG) infusion system infuses Immunoglobulin G (IgG) into subcutaneous tissue in accordance with FDA approved labeling.
In accordance with FDA approved labeling, an Immunoglobulin G (IgG) infusion system is for subcutaneous infusion only.
The computerized cognitive assessment aid provides clinicians in a healthcare setting with objective measurements of cognitive function as a screening aid in the assessment of adults 55 years of age and older. This is done for the purpose of id
Computer-administered battery of cognitive tests, computer keyboard, computer screen.
Uses a battery of objective cognitive tests delivered by computer software to determine an individual's current level of cognitive functioning.
Non-Invasive Vagus Nerve Stimulator - Headache
The device intended for non-invasive vagus nerve stimulation (nVNS) on the side of the neck to treat cluster headache and to reduce the frequency of cluster headache attacks.
The device is a hand-held portable device consisting of an outer plastic case, a battery, signal generating and amplifying electronics, a control to power on the device and control stimulation intensity, and a pair of stainless steel skin conta
The device produces a low voltage electric signal that generates an electric field in the vicinity of the vagus nerve. The strength of the stimulation is lower than that required to activate efferent vagus nerve stimulation that mediates cardia
The device is used on the side of the neck for non-invasive Vagus Nerve Stimulation (nVNS).
Laser For Disruption Of Adipocyte Cells For Aesthetic Use
Laser intended for the disruption of adipocyte cells indicated for body contouring or reduction in circumference of body areas.
The device may include up to three rectangular applicator heads with sapphire glass and dimensions of 4 cm x 6 cm. The laser may be 1064 nm and range in power density from 0.9-1.4 W/cm2.
Laser energy is delivered to the adipose tissue to elevate temperature to 42-47 C for disruption of adipocyte cells. Subsequently, the adipocyte cells release fat and lipids resulting in reduction of the adipose tissue.
Areas of the body for treatment such as the flank, abdomen, thighs, waist, hips
The purpose of the insulin pump secondary display is to notify another person of the patient's insulin pump usage information in real time. The secondary display is intended for providing secondary notification of insulin pump usage and does no
Typically a software device installed on a third-party mobile device, or implemented in a web-based platform.
Receives and displays real-time patient data from an insulin pump.
Implant, Dermal, For Aesthetic Use In The Hands
For hand augmentation to correct volume loss in the dorsum of the hands.
Injectable mixture in a syringe with a needle.
To provide volume fullness to the dorsum (back) of the hand
Esophageal Thermal Regulation And Gastric Suctioning Device
The device is used to control a patient's temperature, while simultaneously maintaining access to the stomach to allow gastric decompression and drainage.
The device is a tube with three lumens made of standard medical-grade silicone. A connector allows the device to interface with an external controller, and another connector connects to wall suction.
The device is inserted into the esophagus, and is attached to an external controller that provides heated or cooled water, which flows in a closed loop through two lumens. A third central lumen connects to wall suction for gastric decompression
The device is inserted into the esophagus and the tip reaches the stomach. The entire body is affected by the temperature of the fluid flowing through the device.
Automated calculation of a summary index (or indices) based on several individual measured vital sign inputs.
Collects measured parameter inputs and automates the calculation of a summary index based on those parameters
Sleep Appliances With Patient Monitoring
For the treatment of night time snoring and mild to moderate  obstructive sleep apnea in patients 18 years of age or older while also measuring patient compliance to oral appliance therapy.
Comprised of two customized splints (upper and lower) held together by a locking mechanism
advances the patient's mandible in a forward position to increase airway space and additionally monitors the patient compliance to oral appliance therapy
Intended to be used with ancillary fixation for opening wedge osteotomies or fusion in the ankle, foot, proximal tibia.
Wedge  with or without graft window made of metal or polymer
A wedge that may act as a spacer and/or hold bone graft in opening wedge osteotomy procedures, column lengthening, or fusion
Intended for use during orthodontic treatment.  It is used in conjunction with brackets and wires or aligners and helps facilitate minor anterior tooth movement.
The system consists of a mouthpiece containing LEDs, software, and battery, and a separate storage/charging station.
The device functions by applying light energy to the tissue surrouding tooth roots for a photobiomodulation effect.
Alverolar ridge of maxillary and mandibular arches of patients currently being treated with orthodontic brackets/wires or aligners.
Intended to support, secure, and hold gastrostomy tubes
Cloth material held together by fasteners
Holds gastrostomy tube in place using strap
Tympanic Membrane Direct Contact Hearing Aid
A tympanic membrane contact hearing aid is intended to compensate for impaired hearing by transmitting amplified sound by vibrating the tympanic membrane through a transducer that is in direct contact with the tympanic membrane.
A tympanic membrane contact hearing aid consists of an externally worn audio processor, and a custom fitted tympanic membrane receiver/transducer.
A tympanic membrane contact hearing aid is a device worn by the patient that uses an external audio processor to transmit amplified sound by vibrating the tympanic membrane through a transducer that is in direct contact with the tympanic membra
A tympanic membrane contact hearing aid provides direct, mechanical vibration of the lateral side of the tympanic membrane.
Intended for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or endoscopic device.
Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System
A meningitis/encephalitis pathogen multiplex nucleic acid detection system is a qualitative in vitro diagnostic test for the direct detection and identification of microbial-associated nucleic acids in cerebrospinal fluid. The test is indicated
Meningitis/encephalitis pathogen multiplex nucleic acid detection systems are in vitro devices that consist of reagents and associated instrumentation for detection and identification of microbial nucleic acids in cerebrospinal fluid specimens.
A qualitative in vitro diagnostic assay that detects and identifies microbial-associated nucleic acids in cerebrospinal fluid specimens.
High Intensity Ultrasound System For Prostate Tissue Ablation
The system consists of a console, a probe with therapy transducer(s), and single use accessories.
Uses high intensity ultrasound to heat target tissue within the prostate gland, causing coagulation necrosis of that tissue.
Cartridge packed with enzyme linked beads
Hydrolyzes fats in enteral formula ex vivo and delivers them into the enteral tract through a feeding tube
Spinal Vertebral Body Replacement Device - Cervical
Vertebral body replacement in the cervical spine.
Metallic or polymeric device (usually rectangular or cylindrical), with open central and lateral canals for bone graft containment, providing rigidity and structural support.
Provides structural support for the indicated population.
A thermal system for insomnia is a prescription device for use in patients with insomnia that is used to apply a specified temperature to the skin surface.
Applies a specified temperature to the skin surface in patients with insomnia.
To facilitate dental implant placement in patients that are partially endentulous or edentulous.
A cart mounted system that physically attaches to the patient as well as the surgical instrument in order to detect the location of the device in physical space.
The device uses stereo cameras to detect tracking devices placed on both the surgical instrument as well as on the patient.  The tracked image is then placed on a screen with predetermined anatomical landmarks to assist the clinician with the s
Intraoral surgical procedures in the mouth.
The acetabular cup orientation system is intended to be used as a surgical instrument to assist in the intra-operative orientation of acetabular cup components used with total hip arthroplasty. The device utilizes anatomic landmarks of the pelv
A patient-matched acetabular guide, made of polymeric material and with a patient-matched surface that is congruent to the mating acetabular surface. May be manufactured through an additive manufacturing process.
The device consists of a software component that generates a pre-operative plan based on the medical imaging data and a hardware component, the patient-matched guide that is positioned onto/within the acetabulum by mating the patient-specific c
A nasolacrimal compression device is a device used to compress the nasolacrimal ducts to reduce drainage by means of temporary occlusion of the nasolacrimal system.  The device may include a nose piece attached to a frame to apply pressure to t
the frame material (e.g., metal) is durable and flexible enough to appropriately fit the frame to the patient and maintain nose pad placement. The nose pads from which the pressure is applied should include padding to mitigate risk of abrasion.
A device of this type uses a nose piece to apply direct pressure to the top of the nasal aspect of the orbital rim to occlude the ducts during application of the pressure.  The pressure can be controlled by means of tightening a strap that is w
Used to reduce the risk of skin flora contamination of the surgical wound during a surgical procedure.
Device is composed of transparent, breathable fluid barrier film laminated to acrylic pressure-sensitive adhesive that contains 2% CHG.  Drape is on a silicone-coated release liner.
Transparent, breathable fluid barrier film laminated to acrylic adhesive that contains 2% w/w Chlorhexidine Gluconate (CHG).  Adhesive drape is on a silicone-coated release liner.
A diurnal pattern recorder system is a non-implantable, prescription device incorporating a telemetric sensor intended to detect changes in ocular dimension for monitoring diurnal patterns of IOP fluctuation.
hydrophillic lens with active strain gauge.  RF receiving antenna connected to a recorder to track data over time. unit also includes dedicated software package to review recorded device
The device is comprise of a hydrophilic, single use soft contact lens with a sensor and antenna embedded in it, allowing for continuous wireless recording of changes in ocular dimension. An external adhesive antenna worn around the eye is used
This device is intended to maintain airway patency using negative pressure during mild to moderate sedation.
The device is a silicone collar that is attached by adhesive and stays on with negative pressure suction.
The device provides negative pressure (suction)to the neck  through a tube that attaches to the wall outlet of a central vacuum system.  The negative pressure is monitored by a user provided regulator that displays the pressure.
The target area is the surface of the mandible and neck which overlay the upper airway tract.
A  scalp cooling system is intended to reduce or prevent the frequency and severity of alopecia during chemotherapy in which alopecia-inducing chemotherapeutic agents are used.
a cooling cap which is placed on the patients head and a cooling system that houses the cooling liquid, controls the temperature, and has a user interface
A cooling cap with cooling fluid running through the cap cools the scalp.    A cooling tank consists of a computer controlled system that includes a refrigerated tank containing the cooling agent that maintain the temperature of the cooling flu
For use on dental restorations, external to the mouth, prior to insertion into the mouth.
Solution consists of a gel or liquid that is applied directly to the dental restoration.
Applied manually by applicator to the dental restoration, then rinsed thoroughly with water and air dried before placement in the mouth.
The target area of the body is a tooth which will have the dental restoration applied to it.
Automated Multicolor Fluorescent Imaging Cytometric Analysis System
An automated multicolor fluorescent imaging cytometer and absorbance spectrometer which utilizes specific single-use reagent cartridges to identify and enumerate specific hematologic subpopulations and parameters (e.g., hemoglobin) using spectr
System may include image cytometer, assay-specific single-use reagent cartridges and reagents, specimen and process controls, dedicated instrument control, data acquisition software and other essential hardware components.
System identifies and enumerates specific leukocyte populations using immunophenotyping methods and image cytometry.  System performs quantification and enumeration of cells using specific fluorescently labeled conjugated antibodies to bind to
Mechanical Compression Device Fecal Incontinence (Non-Manually Operated)
For treatment of fecal incontinence in patients who have failed conservative therapies
The device is comprised of an annular ring (implant), sizing tool and insertion tool.
Compresseion of the anal sphincter through use of magnetic force
Fluorescence In Situ Hybridization, Platelet-Derived Growth Factor Receptor, Beta Polypeptide (Pdgfrb), Rearrangement
A fluorescence in situ hybridization (FISH) assay for PDGFRB rearrangement is a qualitative in vitro diagnostic assay to detect large rearrangements or translocations within the PDGFRB gene locus. It is indicated as an aid in the assessment of
The device is a laboratory assay that consists of slide preparation materials, fluorescent FISH probes, buffers, nuclear counterstain, and a fluorescence-enabled microscope.
The assay uses fluorescence in situ hybridization, manual method, with a dual-labeled break-apart DNA probe. When the PDGFRB genetic locus is intact, a single yellow signal is visualized and when it is rearranged separate red and green signals
Human bone marrow aspirate or peripheral blood
Provides real-time feedback to the rescuer regarding the quality of CPR being delivered to the victim, and provides either audio and/or visual information to encourage the rescuer to continue the consistent application of effective manual CPR i
An external device generally placed on or near the subject/victim and provides audio and/or visual feedback to the rescuer.
Mechanical or electro-mechanical.  No software.
A device that performs a simple function such as proper hand placement and/or simple prompting for rate and/or timing of compressions/breathing for the professionally trained rescuer, but offers no feedback related to the quality of the CPR bei
External device that provides audio and/or visual prompting of rate and/or ventilation and/or proper placement of hands for CPR, in accordance with current CPR Guidelines.
mechanical, electro-mechanical, software can be included. Prompting only -  no real-time feedback related to the CPR being performed.
Near rescuer (non patient contact) on chest - skin contact.
Bone Cement, Posterior Screw Augmentation
The device is intended to augment the fixation of screws in a posterior spinal system construct.
Viscous, polymethylmethacrylate material that set hardens over time.
The device is placed within the prepared bone canal for placement of the posterior screw, and can be delivered through the screw cannulation and fenestrations.
Prepared bone canal in the posterior spine for placement of a screw.
Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
Assayed external quality control material to monitor the performance of microbiology nucleic acid assays for in vitro diagnostic use.
For use with nucleic acid amplification microbiology assays
Not applicable - Single or multi-analyte
Dorsal Root Ganglion Stimulator For Pain Relief
Stimulation of the dorsal root ganglion for the treatment of chronic, intractable pain of the lower limbs.
Main components include implanted leads, implanted neurostimulator, and external programmers
Uses electrical stimulation to the dorsal root ganglion to relieve chronic, intractable pain
Peripheral Blood Processing Device For Wound Management
Preparation of autologous platelet rich plasma gel from a small sample of peripheral blood for wound management.
May include centrifuge and sterile single-use tubes and disposables
Uses centrifugal methods to separate whole blood into components, after which the platelet rich plasma gel is withdrawn
Blood drawn from peripheral veins, PRP gel topically applied to exuding cutaneous wounds such as leg ulcers, pressure ulcers and diabetic ulcers, and mechanically or surgically-debrided wounds
Peripheral Intravenous (Piv) Infiltration Monitor
Peripheral catheter monitor (PIV) indicated for the detection of subcutaneous infiltrations and extravasations.
The device consists of a monitor, a reusable optical sensor cable and a single-use sensor receptacle.
The peripheral intravenous (PIV) monitoring device that uses visible and near-infrared light to measure changes in the optical properties of the tissue near a PIV insertion site to determine if an infiltration of the peripheral catheter has occ
peripherally-inserted IVs (PIVs), generally on the forearm or dorsal aspect of the hand.
Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens
An assay used to determine the level of procalcitonin (PCT) in human serum and plasma as an aid in assessing the mortality for patients diagnosed with severe sepsis or septic shock.
Detection and determination the concentration of PCT (procalcitonin) in human serum and EDTA or heparin plasma specimens.
Containment System, Laparoscopic Power Morcellation, With Instrument Port
Use as a multiple instrument port and tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue considered benign, resected during single-port or multi-site laparoscop
A retractor and boot assembly with a tissue pouch/specimen bag
A tissue pouch is placed through a multi-instrument port to allow for containment of resected gynecologic tissue.  The pouch is insufflated to create a working space for morcellation.  A laparoscopic power morcellator and a laparoscope are plac
For the automated detection of misalignment of the visual axes for prescription use only.
Includes a laser diode (Scanning Laser) that emits a beam of polarized laser light onto the retina based on the principle of retinal birefringence scanning (birefringent nerve fibers that surround the fovea change the polarization state of refl
Absorbable Collagen Hemostatic Agent With Thrombin
Intended for use as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
Hemostatic agent combining tamponade and acceleration of fibrin clot formation
Surgical procedures other than ophthalmic
System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony
To detect the presence of genetic markers of antimicrobial resistance by testing isolated bacterial colonies using nucleic  acid amplification technology.
single-use, disposable assay cartridge and instrument system
qualitative nucleic acid amplification test
The System reports two sets of numbers under two different conditions, one with capacitive barrier to minimize the effect of variables such as oils and sweat on the image and one without the capacitive barrier. The response scale reports numeri
The system includes the following components: (1) The Device, (2) Power cord, (3) USB external cable, (4) Electrode cover, (5) Finger shroud, (6) Reference probe, (7) Reference probe cable, (8) Reference probe shroud, (9) Instructions for Use,
The System consists of the hardware attached to a computer/software system. The measurements are digital photographs acquired when placing a fingertip in contact with a glass electrode. A series of electrical impulses are applied to the glass e
Biliary Stent System For Benign Strictures
A benign stricture biliary stent system is a prescription device intended for treatment of benign biliary strictures. Stents are intended to be left indwelling for a limited amount of time and subsequently removed. The device consists of a meta
Device consists of an expandable metal stent and a delivery catheter
The catheter introducer is intended to provide a path for a catheter to be placed near nerves or into and around wound sites for the delivery local anesthesia.
The needle is made from stainless steel material with a sharp beveled tip. The proximal end of the needle consist of a female luer made of polystyrene. The sheath tube consist of Soltex with a split -T hub. The sheath tube is scored the length
The catheter introducer consist of a stainless steel needle with a sharp tip surrounded by a plastic peelable sheath. The needle with Sheath is inserted through the skin to the wound site or nerves for regional anesthesia. Once at the desired l
The catheter is inserted into the peripheral vascular system for infusion of fluids and medications for less than 28 days.
Consists of a thin, flexible plastic tube that may have a guide wire inside the catheter to add stiffness to facilitate insertion
The catheter is inserted into the peripheral vascular system for infusion of fluids and medications.
The catheter is inserted in the peripheral vascular system (basilic, cephalic, or brachial veins) usually above the antecubital fossa and the tip terminates at or near the axillary area.
Introduce various cardiovascular catheters into the heart and cardiovascular system
Sheath with lumen(s). Polymer-based shaft material for both introducer and dilator. Reprocessed device.
The devices navigate to the target location and facilitate the introduction of cardiovascular catheters to the target location.
Heart and vasculature (coronary and peripheral)
The stent is metal and is offered in a range of diameters
An expandable stent is placed in the aorta to keep the vessel open
Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling
For drainage of refractory ascites with long-term occurrence  from the peritoneal cavity.
Plastic tubing with a tissue ingrowth cuff and valve or connector.
Typically attached to positive pressure or gravity feed to assist in drainage of fluid from the peritoneal cavity.
For the  determination of autoantibodies to Aquaporin-4 in human serum and plasma. The test may be useful as an aid in the diagnosis of Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorders (NMOSD). The test is not to be used a
Calibrators, Controls, and Assay Reagents
Immunological detection of autoantibodies using capture antigen immobilized on solid surface and labeled secondary antibody
To treat bradycardia (slow heartbeats) with right atrial and/or right ventricular pacing therapy as necessary.
Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)
A chromosome 17p deletion (TP53) fluorescence in situ hybridization (FISH) kit is a test to detect deletion of the TP53 gene in peripheral blood specimens from patients with B-cell chronic lymphocytic leukemia (CLL).
Probe Kit consists of slide preparation materials, fluorescent FISH probes, buffers and nuclear counterstain, followed by manual signal enumeration using a fluorescence-enabled microscope.
The assay uses fluorescence in situ hybridization to identify a deletion in chromosome 17 at the TP53 gene locus in peripheral blood from CLL Patients.
System designed to grasp and retract the body and the fundus of the gallbladder in laparoscopic cholecystectomy procedures to facilitate access and visualization of the surgical site.  The device is indicated for use in patients within a BMI ra
The device is two different instruments, the magnetic controller which is outside of the body and is 3x2 inches, oval-shaped with handles and is a large magnet made of NdFeB, Grade N42 disk magnet. The second instrument is the detachable graspe
Uses a detachable grasper that can be attracted with a magnet that goes into the body to grasp and retract the gallbladder. Externally, a large magnet is kept outside of the body to hold the detachable grasper in place during surgery with its m
The magnetic controller is kept external to the body on the abdomen.  The detachable grasper is used during laparoscopic cholecystectomy to grasp and retract the gallbladder inside the body.
The device is software that is to be used for the diagnosis and treatment planning of orthodontic patients and conditions. It may include orthodontic output devices used for the treatment of orthodontics. The device is intended for prescription
Software which may produce an orthodontic appliance
May use software, scanning equipment, CAD/CAM, and printing machines for the fabrication of orthodontic appliances
To reduce vascular stenosis by dilatation and apposition of the cutting/scoring surfaces to the stenotic material
Cutting/scoring catheters are usually comprised of flexible polymers for the catheter body and a compliant polymer for the balloon.  The cutting/scoring elements are usually metal.
The device is typically placed using a guidewire and guiding catheter.  The active end is typically expanded and the cutting/scoring surfaces are apposed to the vessel wall to cause cracking or breaking of the stenosis.
Peripheral arteries and arteriovenous dialysis fistulae
Dental Abutment Design Software For Dental Laboratory
The device is intended to aid in the restoration of chewing function by allowing a dental laboratory or dental clinician to design the patient-specific component of a dental abutment (i.e. abutment collar and abutment post) and CAM or create th
Device is composed of software contained in a standard desktop computer, stand-alone computer unit, or online software, an intra- or extra-oral scanner, and a CAM unit.
The device utilizes a digital image/impression of the patient's oral environment for the purpose of designing and creating a dental abutment.  The device uses a validated CAM unit to create a physical version of the patient specific component o
This device is intended for closure of cardiac apical tissue.
The device is composed of a suture and polymeric anchor system that is placed in cardiac apical tissue using a delivery system.
This device deploys an anchor and suture system into cardiac apical tissue to form an operative window through which apical access can be gained. The device is also used to close the opening.
Enteral Syringes With Enteral Specific Connectors
Delivers nutrition, medication, or hydration orally or to a gastrointestinal tube or extension set using AAMI/CN3(PS):2014 compliant connectors.
Plastic device with barrel, movable plunger, and connector.
The device can be attached to a feeding tube or extension set to administer nutrition, medication, or hydration to a patient using AAMI/CN3(PS):2014 compliant connectors.
For short-term prevention of pulmonary embolism (PE)
Mechanically filters the bloodstream to capture blood clots
Peripheral vasculature (vein), inferior vena cava (IVC)
Pressure Wedge, Perianal, For Reduction Of Cesarean Delivery
Designed to provide counter-pressure to the perianal region during vaginal childbirth to help reduce the likelihood of Cesarean delivery
External device that provides counter pressure to peri-anal region
Provide counter-pressure to the perianal region during vaginal childbirth
Impedance Measuring Device Utilizing Oscillation Techniques
This device measures respiratory impedance.
Device could include a loudspeaker or other means to generate pressure oscillatory signals. The system could also include a bias flow.
Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant
The device is a metatarsophalangeal joint cartilage replacement device that is implanted in the metatarsal head of the first metatarsophalangeal joint.
The device is a molded cylindrical viscoelastic hydrogel implant composed of polyvinyl alcohol and saline.
The device is placed into the metatarsal head in the first MTP joint via press-fit implantation.  The viscoelastic hydrogel form and properties of the device are conducive to replacing focal areas of damaged cartilage, providing pain reduction,
The device is implanted into the metatarsal head in the first MTP joint.
An absorbable scaffold with a drug coating placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen. The drug coating is intended to inhibit restenosis.
Mesh tube in various lengths and diameters
Provides mechanical support to the treated artery and a drug agent to prevent restenosis of the treated artery, and then gradually dissolves and is absorbed by the body.
The device is intended for use in dilating the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction.
A Eustachian tube balloon dilation device consists of a catheter with an inflatable, plastic balloon, which is located at the flexible, distal end. The catheter shaft has a dual lumen to enable inflation of the balloon and has a soft, balled ti
The balloon catheter is loaded through a guide catheter through the nose to the Eustachian tube. The balloon is manually advanced and inserted into the cartilaginous Eustachian tube and inflated to a desired pressure and specified duration. The
Nucleic acid-based in vitro diagnostic devices for the detection of Zika virus and diagnosis of Zika virus infection in human clinical specimens.
In Vitro Diagnostic Primers, Probes and/or capture oligonucleotides.
System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen
To detect the presence of genetic markers of antimicrobial resistance by testing directly from clinical specimens using nucleic acid amplification technology.
Single-use, disposable assay cartridges and instrument system.
Qualitative nucleic acid amplification test.
Intended to control severely bleeding wounds
Hemostatic agent either alone or incorporated into/onto another material, e.g. gauze.
Proposed hemostatic mechanisms of action include coagulation cascade (Factor XII) activation, water absorption, and mechanical sealing.
Indicated for use for severely bleeding wounds such as surgical wounds and traumatic injuries, including organ space bleeding.
Extended Depth Of Focus Intraocular Lens
Intended to be implanted to replace the natural lens of an eye.
An EDF IOL has a similar appearance and construction to any intraocular lens. An intraocular lens is a device made of materials such as glass or plastic.
An Extended Depth of Focus Intraocular lens is one that uses an optical design (e.g., through aspheric shape, use of more than one refractive zone, or diffractive technology) that provides a continuous range of relatively clear vision, beyond t
Like all IOLs, an EDF IOL is implanted within the eye, either within or outside of the capsular bag, in the posterior  or anterior chamber.
Reagents, Ebola Zaire Virus (Detected In The West Africa Outbreak In 2014) Nucleic Acid
Nucleic acid-based in vitro diagnostic devices for the presumptive detection and identification of Ebola Zaire virus (detected in the West Africa outbreak in 2014) in human clinical specimens
An MR-Guided Focused Ultrasound System is intended to use high intensity focused ultrasound (HiFU) to heat and ablate soft tissue in the brain to treat neurological disorders. MR imaging and thermal mapping are used to plan and monitor the use
Transducer Array, Computer Workstation, Water Chiller, MR Table
Device uses high frequency ultrasound to heat and ablate soft tissue.
Lung Tissue Sealant For Lung Volume Reduction
The system is intended to reduce lung volume irreversibly by employing a synthetic polymer to seal airways in order to improve lung function and quality of life in patients with advanced emphysema. It functions by physically occluding both smal
The AeriSeal System is designed to produce lung volume reduction by physically occluding airways, leading to reduced gas trapping in order to improve lung function and quality of life in patients with advanced emphysema.  A single subsegmental
Small airways and collateral air channels of the lung
Reagents, Middle East Respiratory Syndrome Corona Virus (Mers-Co V) Nucleic Acid
Nucleic acid-based in vitro diagnostic devices for the detection of Middle East Respiratory Syndrome Corona virus (MERS-Co V) in human clinical specimens.
Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
A neurovascular mechanical thrombectomy device for acute ischemic stroke treatment is a prescription device used in the treatment of acute ischemic stroke to improve clinical outcomes. The device is delivered into the neurovasculature with an e
The device is delivered into the neurovasculature with an endovascular approach and mechanically removes thrombus from the body and restores blood flow.
Computerized Cognitive Assessment Aid For Concussion
For use as an assessment aid in the management of concussion.
The device consists of a software program that administers a neurocognitive test battery to a subject in order to assess their cognitive status. The device may use off-the-shelf computers or a novel device.
Uses a software-based cognitive test battery as an assessment aid in the management of concussion.
Catheter, Balloon, Dilation Of Cervical Canal
Mechanical dilation and softening of the cervix.
When placed in the cervical canal, the device uses mechanical force to dilate and soften the cervix.
A cranial motion measurement device is a prescription device that utilizes accelerometers to measure the motion or acceleration of the skull.  These measurements are not to be used for diagnostic purposes.
Accelerometer hardware. May include headset to aid in positioning. May include additional sensors (e.g. photoplethysmography). May include hardware and software to allow for data collection and review. Does not include software that outputs any
Uses a headset containing accelerometers positioned around the head to measure motion or acceleration, and may use a photoplethysmography sensor to detect heartbeat.
Physiological Signal Based Seizure Monitoring System
The Physiological signal based seizure monitoring system is a prescription device that uses physiological signal to identify abnormal physiological activity that may be associated with a seizure. The System does not predict seizure onsets, and
The device should contain a part that collects physiological signals (usually attached to the human body) and a base station that provides information to the caregiver or healthcare professionals.
Physiological signal measurement and analysis
The Lockbox is intended to hold a Perfusor Space infusion pump and keep the medication syringe contained within the pump relatively secure.
lockbox is a clear polycarbonate enclosure with a window to access the interface keys on the B. Braun Perfusor Space Syringe Infusion Pump. It has a lockable front door, a carry handle and a lockable pole clamp
The lockbox is an accessory to the Perfusor Space Syringe infusion Pump. It has a lockable front door and may be attached to an IV pole with a lockable pole clamp. The lockbox is a polycarbonate enclosure made to relatively secure access to the
Device used to evaluate one or more human semen parameters including semen volume, sperm concentration, total sperm number, sperm motility, sperm morphology, sperm vitality, white blood cell concentration, and pH.
Semen analysis devices may be found in a range of shapes and sizes with various distinguishing features.
The device may use one or more forms of technology including optical, mechanical, digital imaging, computer algorithms, chromatographic immunoassay and may be manual, automated, or semi-automated.
Crown And Bridge, Long-Term Temporary, Resin
For the fabrication of long-term temporary crowns and bridges
Achieves its intended function by providing a patient-matched crown or bridge that is cemented onto a patient's dentition to restore normal mastication
An Oxcarbazepine Metabolite Assay is an enzyme immunoassay intended for the quantitative determination of Oxcarbazepine Metabolite in human serum. The measurements obtained are used in monitoring levels of Oxcarbazepine Metabolite to help ensur
Foley Catheter Kit (Excludes Hiv Testing)
Male External Catheterization Kit (Excludes Hiv Testing)
Single Needle With Uni-Directional Pump Kit
Hemodialysis Tray (Not A Start/Stop Kit)
Single Needle (Co-Axial Flow) Dialysis Kit
Intended for ultrasound wave enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature.
Catheters that deliver electro-mechanical energy to a blood vessel via a catheter which is connected via a cable to a generator.
Delivered through the peripheral arterial system. Use of shockwave to disrupt plaque or blood clot.
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.Fda.Gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm0
Transtibial Anterior Cruciate Ligament Kit
Surgical Cannulaes & Depth Gauge Kit For Athroscopic Pocedures
Intended to move excess fluid from the target area to another area of the body.
The device consists of fabric garments, which may be filled with air chambers, that are designed to wrap around the head, face, and/or neck and apply compression. The garments may be attached to a controller, which manages inflation/deflation o
Uses compression of the target area to move excess fluid to another area of the body
Cranial Surgical Planning And Instrument Guides
Software and hardware for surgical planning to create patient-specific anatomical models, surgical templates, and guides for use in the marking or cutting of cranial bone for neurosurgical procedures.
Pre-surgical planning including transferring, visualizing, and editing medical data. Patient-specific templates/guides are based on a pre-operative plan and are designed to fit a specific patient. These templates/guides are used to assist a sur
Microbial Colony Image Assessment System
A microbial colony image assessment system is an instrument that is intended to assess the presence or absence of microbial colonies on solid microbiological culture medium, and to interpret their number, phenotypic and morphologic characterist
Solid microbiological culture media are required to conduct the assessment.
Analysis and interpretation of digital images of microbial cultures on solid media.
The adjunctive cardiovascular status indicator is a prescription device based on sensor technology for the measurement of a physical parameter(s). This device is intended for adjunctive use with other physical vital sign parameters and patient
Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
A vaginitis and bacterial vaginosis nucleic acid detection system is a qualitative in vitro diagnostic device for the direct detection of nucleic acid sequences from microorganisms associated with vaginitis or bacterial vaginosis.  The device i
In vitro device consisting of reagents and associated instrumentation for detection of nucleic acid sequences from microorganisms associated with vaginitis or bacterial vaginosis.
Qualitative in vitro diagnostic device that detects nucleic acid sequences from microorganisms associated with vaginitis or bacterial vaginosis.
A pedicle screw placement guide is intended to be used as a surgical instrument to assist in the intra-operative placement of pedicle screws that are used to anchor pedicle screw spinal systems onto the posterior elements of the spine. The devi
A pedicle screw placement guide, made of polymeric or metallic material, which contains a patient-matched surface that is congruent to the mating surface of the posterior elements of the spine.
The device consists of a both a software and hardware component. The software component generates a pre-operative plan based on medical imaging data. The hardware component consists of a patient-matched guide that is positioned onto the posteri
Blood Specimen Collection Convenience Kit (Excludes Hiv)
A non-adjunctive invasive glucose sensor is intended to determine glucose levels, and the direction and rate of change of glucose levels in people with diabetes. The device is indicated to replace information obtained from standard blood glucos
This device comprises a skin piercing sensor containing the glucose specific biological sensor, an algorithm that converts sensor signals into glucose values, a display device which provides glucose values to the user and a mechanism for transm
Signals from an invasive (skin piercing) glucose specific biological sensor are algorithmically converted to glucose values which are provided to the user.
Iodinated Contrast Media Transfer Tubing Set
The iodinated contrast media transfer set is intended to transfer iodinated contrast media from imaging bulk package contrast media in a controlled ambient environment.  The transfer set is intended to be used to directly fill multiple sterile
Transfer with swabbable valve to directly connect to single use sterile syringes.
Transfer set may include a swabbable one way valve to aid in filling of single use sterile syringes and prevention of microbial ingress.
Device does not act on any part of the body.
A prescription device intended to be used by a surgeon to retract the surgical incision, to provide access to the surgical wound, to protect and irrigate the surgical wound, and to serve as a conduit for removal of fluid from the surgical wound
The device is comprised of a flexible, double-walled sheath with an impermeable inner layer.  The retraction component is formed by attaching the sheath to a fixed-diameter ring at the bottom of the device.  The sheath also includes an integrat
The device is sterile, single-use surgical wound retraction that integrates surgical retraction, wound barrier protection, and fluid delivery and removal. Fluid is delivered via gravitational feed from an external sterile irrigation solution ba
This device type is intended to temporarily increase tear production using neurostimulation in adult patients.
The intranasal tear neurostimulator is a handheld device with two electroconductive tips that are inserted into the nasal cavity during neurostimulation. The disposable tips are made of rigid biocompatible USP Class VI plastic and the conductiv
The device activates tear production through stimulation of the nasolacrimal reflex. Stimulation activates the primary sensory afferent fibers in the ophthalmic and maxillary branches of the trigeminal nerve (CNV1 and CNV2). The device design l
The device is intended to precipitate surgical smoke to allow surgeons adequately visualize laparoscopic surgeries in the using surgical smoke/aerosolized particulate surgical tools.
The device consists of an ion delivery system and a power source.
The device is introduced into the laparoscopic site and provides the source of the ions that charge the surgical smoke particles and facilitate precipitation of surgical smoke and other aerosolized particulates
The device is intended for laparoscopic surgery sites.
Carbon Dioxide Gas Controlled Tissue Expander
A carbon dioxide gas controlled tissue expander is intended for tissue expansion.
It includes an inflatable elastomer shell with an implanted canister containing compressed carbon dioxide.  It includes a remote controller that communicates with the implanted tissue expander to release carbon dioxide from the implanted canist
A carbon dioxide gas controlled tissue expander is made of an inflatable elastomer shell and is filled with carbon dioxide gas.  It utilizes a remote controller to administer doses of carbon dioxide gas from an implanted canister inside the tis
Software that integrates a network of sample pooling instruments, and manages the overall blood analysis sample workflow. Software acquires and processes data from various donor screening, diagnostic, multiplex assay instruments.
Standalone software running on a PC or on a mobile platform.
Software accesses various instruments either wirelessly or wired through the communication protocol defined by these instruments. Software retrieves data stored in these instruments and creates a workflow repository of the samples tested.
Intended for intramuscular or subcutaneous injection of epinephrine.
A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger.
A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic sin
Gbs Culture Media, Selective And Differential
Variola Virus Nucleic Acid-Based Detection Assay
The Variola virus nucleic acid-based detection assay is intended for individuals presenting with pustular or vesicular rash illness or other signs and symptoms of Variola virus infection.  The test results must be used in conjunction with other
The Variola virus nucleic acid-based detection assays are in vitro diagnostic devices that consist of reagents and associated instrumentation for the detection and identification of Variola virus nucleic acids in human clinical specimens.
Qualitative in vitro diagnostic assay that detects and identifies Variola virus nucleic acids in human clinical specimens.
Drug-Coated Peripheral Transluminal Angioplasty Catheter
Balloon dilatation of native and/or synthetic arteriovenous dialysis fistulae to establish or maintain patency
The balloon catheter is generally constructed of synthetic materials such as plastic and introduced into the body using a guidewire. The balloon is generally manufactured in multiple diameters and lengths to allow for treatment of different les
The balloon catheter uses mechanical force across a lesion to establish patency. The drug coating serves as an adjunct to the mechanical action of balloon angioplasty and assists in maintaining vessel patency post-procedure.
Synthetic and/or native arteriovenous dialysis fistulae.
Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers
A quantitative gene expression assay using reverse transcription polymerase chain reaction to quantify the relative expression levels of host response genes isolated from whole blood.
Reverse transcription + quantitative PCR(RT-qPCR)
Whole blood collected in RNA collection tube.
Measures levels of Docetaxel or Paclitaxel in the blood
To aid in decision making on antibiotic therapy, including antibiotic initiation and discontinuation, for inpatients or patients in the Emergency Department, with suspected or confirmed lower respiratory tract infections (LRTI) defined as commu
Human serum and EDTA or heparin plasma specimens.
Capillary Blood Collection Device For Alternative Site Collection
A capillary blood collection device with or without integrated micro-needles is a blood collection device intended to collect and/or transport capillary whole blood specimens for testing of clinical analytes.
Sterile blood collection device which may or may not have micro-needles or other skin puncture mechanism integrated with the device.  The device may include an anticoagulant or preservative.
The blood is drawn into the collection device by puncture of capillaries located near the surface of the skin using micro-needles or similar small sharp objects.
Capillary whole blood for in vitro diagnostic testing
To provide visual indication of each exhalation event
The device includes a thermistor that could detect the temperature change of breath. Supplemental oxygen could also be provided.
The device measures the time period between the current and previous exhalation and illuminates a different light during the exhalation that reflects the interval of time between breaths. This device does not calculate breath rate, e.g., breath
For the treatment of de novo or restenotic lesions found in iliac arteries
Physical mesh tube placed in the vessel to hold open
Enteral Administration Kit (Adult & Pediatric)
Device used to physically restrain a pediatric patient for a short surgical or clinical procedure such as circumcision. Not intended for prolonged positioning.
Made of non-permeable and non-porous material
The pediatric position holder is a device made of non-permeable and non-porous material and molded with smooth edges for single patient use or multi-patient reuse.   Holders that use disposable straps are used to hold an infant or a child in an
Gastric Lavage Kit (Adult Or Pediatric Use)
Gastrostomy Jejunostomy Feeding Tube Kit
Percutaneous Replacement Gastrostomy Tube Kit
Replacement Gastrostomy Feeding Catheter Tray
25-Oh-Vitamin D Mass Spectrometry Test System
A 25-OH-Vitamin D Mass Spectrometry test system is intended to  for vitro diagnostic use in the quantitative determination of total 25-hydroxyvitamin D (25-OH-D)using mass spectrometry.
Mass spectrometer, liquid chromatography-tandem mass spectrometer
Liquid chromatography-tandem mass spectrometry (LC-MS/MS), mass spectrometry
For total protein testing of plasma donors to determine eligibility.
Refraction index to determine total protein concentration
Emission and collection of light to create an image for medical purposes
Device is a light source in a housing and light detectors in a housing that can be aimed at a target tissue
Device emits light that is collected from the target tissue and then analyzed to provide information about the target
Intracranial Pressure & Temperature Monitoring Kit
Intracardiac Patch Or Pledget, Biologically Derived
To repair defects, to be used for patch grafting, to repair tissue, and to buttress sutures in the heart and vasculature.
The device is a biologic tissue, typically in the form of a sheet. The tissue may be decellularized or crosslinked, and may be derived from human or animal sources.
The device is sutured into the intended site to repair or support the native tissue.
Implanted Phrenic Nerve Stimulator For Central Sleep Apnea
The device is intended to stimulate the phrenic nerve to produce diaphragm movement during sleep.
The device may include an implantable pulse generator (IPG), respiratory sensing and stimulation leads.  The device may also include external components such as a physician programmer.
The device is an implanted nerve stimulator which provides electrical stimulation of the phrenic nerve in order to contract the diaphragm and stimulate the patient to take a breath.
Minoxidil Sulfotransferase Or Isoenzymes Test System
For measurement of Minoxidil sulfotransferase as an aid in assessing the likelihood that a patient will respond to minoxidil.
Colorimetric in vitro diagnostic assay performed by a medical professional
To correct annular dilatation and/or maintain annular geometry of the aortic valve.
A three dimensional crown or waveform shaped ring.
A solid or compliant ring attached to the aortic annulus.
An ultrasound bronchoscope is indicated for the ultrasonic visualization, diagnosis and therapeutic access to the  bronchial tree or the lungs.    If the device is reusable, validated reprocessing instructions and reprocessing validation data f
An ultrasound bronchoscope has a built-in ultrasound transducer (probe) at the distal end. When used with an ultrasound processor the ultrasound bronchoscope produces ultrasound wave and scans the signals reflected by tissues to generate the ul
High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid
To provide high level disinfection of ultrasound transducers    If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available
ultrasonic transducer reprocessor, high level disinfectant liquid, and accessories
Automatically delivers liquid disinfectant and exposes a suspended ultrasound transducer to the disinfectant at a specified temperature and for a specified time to achieve high level disinfection and then rinses the ultrasound transducer with w
These devices are intended to measure chlorine levels in water.
An automated or manual sampling system, which can measure chlorine levels in water. Typically used as a component of hemodialysis or water treatment systems but not able to treat or alter the water used in dialysate.
Measurement of chlorine levels (free chlorine and/or chloramines) based on a chemical reaction correlation.
Not used in the body: Used in hospitals and hemodialysis clinics and homes equipped with a water treatment system.
Devices Detecting Influenza A, B, And C Virus Antigens
An influenza virus antigen detection test system is a device intended for the qualitative detection of influenza viral antigens directly from clinical specimens in patients with signs and symptoms of respiratory infection.
Devices detecting influenza A, B, and C virus antigens are in vitro diagnostic devices that consist of reagents and associated instrumentation for the detection and identification of influenza virus antigens
A qualitative in vitro diagnostic assay that detects and identifies influenza virus antigens
Genetic Variant Detection And Health Risk Assessment System
A qualitative in vitro molecular test that detects variants in genomic DNA isolated from human specimens. This assessment system provides users with a genetic health risk assessment of developing a disease and is intended to inform users of lif
Qualitative in vitro molecular diagnostic system used to detect variants in genomic DNA from human specimens. System accessory includes collection device for human specimen.
Qualitative in vitro molecular diagnostic system used to detect variants in genomic DNA isolated from human specimens. Genetic risk assessment of developing a disease is based on scientifically established disease-risk association for each vari
Device used to determine the extent of ataxia (failure of muscular coordination) by measuring the amount of swaying of the body when the patient is standing erect and with eyes closed and provides interpretation or clinical implication of the m
Sensors applied to the body and software to analyze and interpret the signals.
Uric Acid Test System For At Home Prescription Use
For the quantitative measurement of uric acid in home use settings by patients diagnosed with gout. This device is for prescription use only.
Capillary whole blood, in vitro diagnostic use.
A subcutaneous implanted apheresis port is a prescription device intended for patient therapies requiring repeated access to the vascular system and long-term therapeutic apheresis
A subcutaneous implanted apheresis port includes the port body, intravascular catheter, and over-the-needle I.V. catheter for port access.
An apheresis port is for patient therapies requiring repeated access to the vascular system. The port system can be used for the infusion of medications, I.V. fluids, parenteral nutrition solutions, blood and blood products, withdrawal of blood
In accordance with FDA approved labeling, a subcutaneous implanted apheresis port is a prescription device intended for patient therapies requiring repeated access to the vascular system and long-term therapeutic apheresis.
For use in endoscopic procedures by a trained gastroenterologist to resect and remove residual tissue from the peripheral margins following EMR (Endoscopic Mucosal Resection)
Rotating, cutting cannula with aspiration of tissue
Mechanical removal of gastrointestinal tissue
Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission
Assay to measure procalcitonin to aid in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock
Latex particle enhanced immunoturbidimetric method intended for the quantitative determination of PCT in serum, EDTA or lithium heparin plasma.
Detection and determination of procalcitonin (PCT) concentration in serum or plasma
The methadone test is an in vitro diagnostic test for the qualitative analysis of methadone in human urine.
The barbiturate test is an in vitro diagnostic test for the qualitative analysis of barbiturates in human urine.
The non-coring needle (Huber) is utilized to gain access into a subcutaneous implanted intravascular infusion port but can also be used to access other non-vascular implanted devices with similar septums.
A sterile non-coring (Huber) needle used under sterile conditions to pierce the skin above a subcutaneous implanted intravascular infusion port. Once the port is accessed, the needle is pushed through the septum into the port reservoir body tha
Various subcutaneous locations; upper arms, chest and abdomen. Indirectly effects the central venous vascular system by facilitating the delivery of intravenous fluids, medications, contrast media and the withdrawal of blood for laboratory samp
Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates
Qualitative detection of carbapenemase enzymes in pure colonies of Enterobacteriaceae and Pseudomonas aeruginosa that have elevated MIC values to any Carbapenem
Pediatric Esophageal Atresia Anastomosis Device
Lengthening atretic esophageal ends < 4cm apart and creating an anastomosis with a non-surgical procedure in pediatric patients, up to one year of age with esophageal atresia without a tracheoesophageal fistula (TEF) or in pediatric patients up
Plastic tubes, neodymium iron boron magnets
Uses magnets advanced through esophageal and gastric catheters to bore through tissue and create an anastomosis.
This product code is the class II exempt counterpart of DQX, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (51
Exemption is limited to accessory torque devices that are manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guidewires.
This product code is the class II exempt counterpart of MAV, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (51
Exemption is limited to non-patient contacting balloon inflation syringes intended only to inflate/deflate balloon catheters and monitor pressure within the balloon.
Reservoir, Blood, Cardiopulmonary Bypass, Exempt
This product code is the class II exempt counterpart of DTN, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (51
Exemption is limited to cardiopulmonary bypass blood reservoirs that do not contain defoamers or blood filters.
This product code is the class II exempt counterpart of ETY, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (51
Exemption is limited to auditory impedance testers that are in compliance with FDA-recognized consensus standard ANSI S3.39.
This product code is the class II exempt counterpart of NAS, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (51
Exemption is limited to tympanometers that are in compliance with FDA-recognized consensus standard ANSI S3.39.
This product code is the class II exempt counterpart of FCC, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (51
Exemption is limited to single use endoscopic magnetic retrievers.
This product code is the class II exempt counterpart of KGD, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (51
Exemption is limited to sterile, single use scissors for cystoscope.
Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt
This product code is the class II exempt counterpart of OCZ, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (51
Exemption is limited to disposable, single use non-powered endoscopic grasping/cutting instruments.
Biliary Catheter For Irrigation And Contrast Injection, Exempt
This product code is the class II exempt counterpart of GCA, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (51
Exemption is limited to biliary catheters used during a procedure for irrigation of the biliary tree and for contrast injection that do not include a balloon component.
Catheter, Peritoneal, Long-Term Indwelling, Exempt
This product code is the class II exempt counterpart of FJS, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (51
Exemption is limited to non-patient contacting catheter finger grips.
Catheter, Peritoneal Dialysis, Single Use, Exempt
This product code is the class II exempt counterpart of FKO, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (51
Exemption is limited to non-patient contacting, single use catheter finger grips.
System, Peritoneal, Automatic Delivery, Exempt
This product code is the class II exempt counterpart of FKX, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (51
Exemption is limited to continuous ambulatory peritoneal dialysis (CAPD) belts and catheter stands that do not include weigh scales.
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, Exempt
This product code is the class II exempt counterpart of GAQ, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (51
Exemption is limited to steel monofilament sutures that are uncoated and do not incorporate barbs.
Computerized Cognitive Assessment Aid, Exempt
This product code is the class II exempt counterpart of PKQ, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (51
Exemption applies only to computerized cognitive assessment aids that are not used for diagnostic assessment for specific diseases or conditions and rely on inputs from visual cues, auditory cues, and/or functional use of the hand.
This product code is the class II exempt counterpart of HEX, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (51
Exemption is limited to standard colposcopes (and colpomicroscopes) that use only a white light source, do not use filters other than a green filter, do not include image analysis software, and are not smartphone-based.
This product code is the class II exempt counterpart of HDC, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (51
Exemption is limited to sterile, single use urterine tenaculum devices that do not use suction.
This product code is the class II exempt counterpart of MQG, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (51
Exemption is limited to simple embryo incubators with temperature, gas, and humidity control only; syringe pumps; collection tube warmers; dish/plate/microscope stage warmers; and controlled-rate cryopreservation freezers.
Microtools, Assisted Reproduction (Pipettes), Exempt
This product code is the class II exempt counterpart of MQH, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (51
Exemption is limited to assisted reproduction microtools (pipettes) manufactured from glass.
This product code is the class II exempt counterpart of MQK, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (51
Exemption is limited to dishes and plates that are intended for general assisted reproduction technology procedures.
This product code is the class II exempt counterpart of HJO, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (51
Exemption is limited to slit-lamp, AC-powered biomicroscopes intended only for the visual examination of the anterior segment of the eye, are classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, do not provide any quantitati
This product code is the class II exempt counterpart of MQU, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (51
Exemption is limited to ocular pegs supplied sterile.
This product code is the class II exempt counterpart of MRQ, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (51
Exemption is limited to standalone nitrogen dioxide analyzers and not those that are components of nitric oxide delivery systems used to monitor nitrogen dioxide levels during inhaled nitric oxide therapy.
This product code is the class II exempt counterpart of MNW, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (51
Exemption is limited to body composition analyzers which are not intended to diagnose or treat any medical condition.
This product code is the class II exempt counterpart of KKX, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (51
Exemption is limited to surgical drapes that do not include an antimicrobial agent.
A voriconazole test system is a device intended to measure voriconazole in human serum. Measurements obtained by this device are used in monitoring levels of voriconazole to ensure appropriate therapy.
Accessory device that secures intravenous administration sets (IV lines/tubing) to mobile transport devices.
Can be made of molded plastics, metal, hook and loop tape for attachment to various patient transport medical devices by means of a securement. Once the accessory device is secured to patient transfer device, the intravenous administration set
Mechanical connects / attaches to medical bed, wheelchair or mobile patient medical equipment.
Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered
Used to perform anterior capsulotomy during cataract surgery
RF power console and handpiece. The handpiece has the cutting element that delivers energy for capsulotomy.
A corneal incision is made into the anterior chamber of the eye. A cutting element is inserted through the incision and centered on the lens capsule. Energy is directed to the cutting element, creating the capsulotomy. The cutting element is re
Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures
Embolic protection for transcatheter intracardiac procedures
This device is a single use percutaneous catheter system that has (a) blood filter(s) at the distal end and is introduced into an artery through the skin using a guidewire.
This device is a single use percutaneous catheter system that is introduced into an artery.
Aortic arch or aortic arch branch vessels.
The kit is composed of a comb or comb-like device, and a solution intended to remove and/or kill lice and nits.
The solution is intended to remove and/or kill lice and nits; the solution also may lubricate the hair to facilitate removal of dead lice and nits with the supplied comb.
To assist in disinfecting, rinsing and storing endoscopes or similar elongated instruments.
Wall-mounted tube for holding disinfectant solution and endoscope insertion tubes and accessories
The device consists of wall-mounted vertical tubes made of clear seamless PVC that hold endoscope insertion tubes or similar elongated instruments and accessories during disinfection and rinsing.  After draining the solution and rinse water, th
Multiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm
The kit is a multiplex flow immunoassay intended for the qualitative detection of IgM antibodies to Toxoplasma gondii (T. gondii), Rubella, and Cytomegalovirus (CMV) in human serum and plasma.
The device utilizes multiplex fluorescence technology.
The vacuum syringe is intended to be used as a general purpose syringe for injection and withdrawal of fluids and can be locked in place to create a vacuum for removal of  fluid and/or tissue  from the body in the form of thrombus, abscess flui
The vacuum syringe consists of a barrel, plunger, piston seal and a locking mechanism.
A vacuum syringe may be used in instances where fluid and/or tissue needs to be removed from the body in the form of thrombus, abscess fluid, and infected fluid (e.g. urine, bile, etc,). Thrombus and other fluid can be thick, which makes it dif
System, Test, Radioallergosorbent (Rast) Immunological, Exempt Allergens
Intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings, and is to be used in clinical laboratories.    FDA has exempted these devices from the prem
May include instruments (as a test system), calibrators, and controls
Immunoassay containing allergenic material to capture allergen-specific IgE
Test, Amphetamine, Employment And Insurance Testing, Exempt
The amphetamine test is an in vitro diagnostic test for the qualitative analysis of amphetamine for employment and insurance testing.    FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Reg
Test, Barbiturate, Employment And Insurance Testing, Exempt
The barbiturate test is an in vitro diagnostic test for the qualitative analysis of barbiturates for employment and insurance testing.    FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Re
Test, Benzodiazepine, Employment And Insurance Testing, Exempt
The benzodiazepine test is an in vitro diagnostic test for the qualitative analysis of benzodiazepines for employment and insurance testing.    FDA has exempted these devices from the premarket notification requirement by publishing in the Fede
Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt
The cocaine and cocaine metabolite test is an in vitro diagnostic test for the qualitative analysis of cocaine and cocaine metabolites for employment and insurance testing.    FDA has exempted these devices from the premarket notification requi
Test, Codeine, Employment And Insurance Testing, Exempt
The codeine test is an in vitro diagnostic test for the qualitative analysis of codeine for employment and insurance testing.    FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of
Test, Methamphetamine, Employment And Insurance Testing, Exempt
The methamphetamine test is an in vitro diagnostic test for the qualitative analysis of methamphetamines for employment and insurance testing.    FDA has exempted these devices from the premarket notification requirement by publishing in the Fe
Test, Methadone, Employment And Insurance Testing, Exempt
Test, methadone, employment and insurance testing, exempt    FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https://www.federalregiste
The methadone test is an in vitro diagnostic test for the qualitative analysis of methadone in human specimens. The test is intended for employment and insurance testing use as the first step in a two step process to provide information concern
Test, Methaqualone, Employment And Insurance Testing, Exempt
The methaqualone test is an in vitro diagnostic test for the qualitative analysis of methaqualone for employment and insurance testing.    FDA has exempted these devices from the premarket notification requirement by publishing in the Federal R
Test, Morphine, Employment And Insurance Testing, Exempt
The morphine test is an in vitro diagnostic test for the qualitative analysis of morphine for employment and insurance testing.    FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register
Test, Opiates, Employment And Insurance Testing, Exempt
The opiates test is an in vitro diagnostic test for the qualitative analysis of opiates for employment and insurance testing.    FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of
Test, Propoxyphene, Employment And Insurance Testing, Exempt
The propoxyphene test is an in vitro diagnostic test for the qualitative analysis of propoxyphene for employment and insurance testing.    FDA has exempted these devices from the premarket notification requirement by publishing in the Federal R
Test, Cannabinoid, Employment And Insurance Testing, Exempt
The cannabinoid test is an in vitro diagnostic test for the qualitative analysis of cannabinoids for employment and insurance testing.    FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Re
Test, Tricyclic Antidepressant Drugs, Employment And Insurance Testing, Exempt
The tricyclic antidepressant drugs test is an in vitro diagnostic test for the qualitative analysis of tricyclic antidepressant drugs for employment and insurance testing.    FDA has exempted these devices from the premarket notification requir
Endoscopic Ventricular Catheter Placement Kit
Rickettsia Spp. Nucleic Acid Based Detection Assay
An in vitro diagnostic test for the detection of Rickettsia spp. nucleic acids in specimens from individuals with signs or symptoms of rickettsial infection and epidemiological risk factors consistent with potential exposure. Test results are u
In vitro diagnostic devices that consist of reagents and associated instrumentation for the detection and identification of Rickettsia spp. nucleic acids in human clinical specimens.
Qualitative in vitro diagnostic assay that detects and identifies Rickettsia spp. nucleic acids in human clinical specimens.
Clinical specimens from patients suspected of infection with Rickettsia spp.
Fetal Blood Sampling Kit (Excludes Hiv Testing)
A hypodermic needle is intended to inject medication and aspirate fluid, below the surface of the skin. Designed to be used with ultrasound for better visualization of needle during use.
Various locations of the body for general purpose use for injection of medication and aspiration of fluid where the needle gauge and length are appropriate based on anatomy and clinical need.
Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure
Designed to be used in conjunction with powered or non-powered breast pumps to apply positive pressure to the breast to aid in milk expression from the breasts of a nursing woman.
Provide low, positive pressure to the breast to aid in expression of milk in conjunction with a powered or non-powered breast pump.
To elevate the fetal head and facilitate delivery of the fetus in women requiring a Caesarean Section at full dilation or those requiring a Caesarean Section after a failed instrumental vaginal delivery.
Inflatable balloon device that provides pressure to the fetal head.
Provides pressure via an inflatable balloon inserted into the vaginal canal to elevate the fetal head.
General wellness product as detailed in the guidance for purposes of imports only: https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm429674.pdf
General wellness product as detailed in the guidance for purposes of imports only: https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm429674.
Flow Cytometric Test System For Hematopoietic Neoplasms
Reagents intended for in vitro diagnostic use as a panel for qualitative identification of cell populations by multiparameter immunophenotyping on a flow cytometer. These reagents are used as an aid in the differential diagnosis of hematologica
Monoclonal and polyclonal antibody cocktails in panels, accessory reagents including software and beads used for analysis and acquisition of data.
These reagents provide multiparameter, qualitative results for the Cluster of Differentiation (CD) parameters.
Whole blood, bone marrow, and lymph node specimens.
Cognitive Behavioral Therapy Device For Psychiatric Disorders
The device is intended to provide cognitive behavioral therapy to treat substance use disorder.
The device is a software-based mobile app downloaded onto a smartphone.
The device is a software-based mobile app that provides a computerized version of behavioral therapy to the patient.
The device is intended to provided psychiatric treatment.
Stabilization of the posterior thoracic and lumbar spine
The spinal rods and connectors are made of titanium alloy per ASTM standards.
The subject spinal rods and connectors attach to the posterior spine with pedicle screws and/ or hooks.
Administrations Sets With Neuraxial Connectors
The connector for neuraxial applications is intended to facilitate ANSI/AAMI/ISO 80369-6:2016 compliant neuraxial  specific connections.
The connector consists of a ISO 80369-6 compliant connection and may be composed of plastic.
The neuraxial connector is attached to a small bore connector intended to be used for neuraxial applications and intended to facilitate in administration of medication or act as a transitional piece to be used with administration sets with a no
Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse
Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for transvaginal pelvic organ prolapse repair
Needle passers and trocars, needle guides, fixation tools, and tissue anchors used with urogynecologic surgical mesh
Used with urogynecologic surgical mesh instrumentation to facilitate transvaginal pelvic organ prolapse repair procedures
Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence
Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for stress urinary incontinence
Needle passers and trocars, needle guides, fixation tools, and tissue anchors used with surgical mesh.
Used with urogynecologic surgical mesh instrumentation to facilitate stress urinary incontinence procedures
Instrumentation, Surgical Mesh, Urogynecologic, Transabdominal Repair Of Pelvic Organ Prolapse
Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for transabdominal pelvic organ prolapse repair
needle passers and trocars, needle guides, fixation tools, and tissue anchors used with surgical mesh.
Used with urogynecologic surgical mesh instrumentation to facilitate transabdominal pelvic organ prolapse repair procedures
Lumbar Puncture Tray (Adult & Pediatric)
Fish (Fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp.
The Plasmodium sp. FISH is intended to detect Plasmodium spp. parasites and/or differentiate parasite species in clinical whole blood smear specimens from patients with signs or symptoms of malaria and suspicion of infection.
In vitro diagnostic devices and reagents that consist of slides, fixatives, fluorescently labeled probes, buffers, and associated instrumentation (if applicable) for the detection and identification of Plasmodium spp. parasites in clinical whol
Fluorescence In Situ Hybridization using labeled nucleic acid probes
Target Area	Clinical whole blood smear specimens from patients suspected of infection with Plasmodium spp.
Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test
For the quantitative determination of low-density lipoprotein (LDL) cholesterol sub-fractions.
The assay uses surfactants and enzymes that react with certain groups of lipoproteins.
The device is intended to enable access to secure patient identification and device information when used with complete dentures, partial dentures, and other removable oral appliances.
Solid state RFID transponder embedded in a resin
Uses RFID transponder  and NFC to transmit information to a mobile device.
Neuraxial Administration Set - Intrathecal Delivery
Neuraxial Administration Sets used to deliver fluids to the intrathecal space.
Administration sets are made of polymers and connected to infusion pumps or medication containers such as syringes or flexible medication containers.
Administration sets are made of polymers, are connected to infusion pumps or medication containers (i.e. syringes, flexible medication containers), and are used to deliver fluids from the storage container or pump into the intrathecal space. Th
Zika virus serological reagents are devices that consist of antigens and antisera for the diagnosis of Zika virus infection in human clinical specimens from individuals that have signs and symptoms consistent with Zika virus infection and/or ep
In Vitro Diagnostic antigens and antisera
This device type is intended to cleanse the eyelid margins and eyelashes by a healthcare professional.
The eyelid cleaning device is a handheld device that spins a soft micro-sponge in the horizontal axis. The handpiece is made out of stainless steel and plastic, and the micro-sponge is composed of polyvinyl alcohol. The handpiece works with a l
The eyelid cleaning device is a device that cleanses the eyelid margins using a medical grade micro-sponge and eyelid cleansing foam. The micro-sponge is applied to the lower and upper eyelid margins and eyelashes to remove debris. A healthcare
Hospital Continuous Glucose Monitoring System
Intended for the continuous, quantitative measurement of glucose in whole blood in a hospital setting.
The device system is comprised of a cartridge and an instrument that measures and displays the result.
The operator connects the device to the blood source of the patient and activates the assay.
Temporary Non-Roller Type Right Heart Support Blood Pump
Providing temporary partial or full right heart circulatory support.
Rotor or axial type pump manufactured of various materials. Single use, disposable.
Assists with partial or full right heart blood circulation either during an adjunctive procedure where the patient requires hemodynamic stability, or a temporary use of the device to unload the right heart to give it time to recover from an acu
Ablation System, High Intensity Focus Ultrasound (Hifu), Soft Tissue
An Imaged-Guided Focused Ultrasound System is intended to use high intensity focused ultrasound (HiFU) to heat and ablate soft tissue.
Transducer Array, Computer Workstation, Water Chiller, Image Table.
An Imaged-Guided Focused Ultrasound System is intended to Device uses high frequency ultrasound to heat and ablate soft tissue.
Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated
A subcutaneous factory calibrated, non-adjunctive, invasive, passive monitoring glucose sensor is intended to determine glucose levels and the direction and rate of change of glucose levels in people with diabetes. Calibrated at the point of ma
This is a qualitative DNA detection in vitro diagnostic test to be used in conjunction with a visualization instrument and its software. This test is for the simultaneous detection and identification of allelic variants found in the Alpha-1 ant
Qualitative in vitro molecular diagnostic system used to detect variants in SERPINA1 gene in genomic DNA isolated from human specimens. The accompanying software application is used to view and analyze genotype data and conducts a variety of co
Qualitative in vitro molecular diagnostic system used to detect variants in SERPINA1 gene in genomic DNA isolated from human specimens. The results of this assessment system are to be used in conjunction with clinical findings and other laborat
Prescription Use Blood Glucose Meter For Near-Patient Testing
Intended for use in near-patient testing settings for in vitro diagnostic, multiple-patient use for the quantitative determination of glucose throughout all hospital and all professional healthcare settings for use in determining dysglycemia.
The device is comprised of glucose test strips and a meter that measures and displays the result.
The user obtains a blood sample and applies it to a test strip that contains an enzyme that reacts with the glucose on the test strip. The test strip is inserted in the meter, which measures the amount of glucose in the blood sample.
For quantitative determination of Placental Growth Factor (PlGF).
Software For Visualization Of Vascular Anatomy And Intravascular Devices
Visualization and measurement of blood vessels and intravascular devices for preoperational planning.
Processing radiographic data to visualize vascular anatomy and intravascular devices.
Percutaneous Nerve Stimulator For Opioid Withdrawal
Stimulate nerve branches to aid in the reduction of symptoms associated with substance use disorders.
A signal generator connected to percutaneous electrodes.
Electrical stimulation of nerve branches using percutaneous electrodes.
Long term support greater than 6 hours for acute respiratory or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent.
The device consists of a catheter with dual lumens. Holes in the outer and inner lumens allow for ingress and egress of blood.
The device is inserted into the vasculature and connected to other devices in the ECMO circuit to allow for drainage and reinfusion of blood during ECMO procedures.
The device is inserted into the vasculature and connected to the extracorporeal circuit to allow for circulation of blood.
Peripheral Blood Processing Device For Osteoarthritis
Preparation of autologous anti-inflammatory (AAI) solution from a small sample of peripheral blood for treatment of osteoarthritis.
May include centrifuge, filters, tubes, syringes, needles, other disposables, and anticoagulant.
Uses centrifugal and/or filtration methods to separate the whole blood into components, after which the autologous anti-inflammatory (AAI) solution is withdrawn.
Blood drawn from peripheral veins, AAI applied to the joint via intra-articular injection.
Bone Marrow Processing Device For Clinical Use
Preparation of concentrated bone marrow aspirate (cBMA) from a sample of bone marrow for clinical use
May include centrifuge, filters, tubes, syringes, needles, other disposables and anticoagulant
Uses centifugal and/or filtration methods to separate the bone marrow into components, after which the concentrated bone marrow cells are withdrawn
Bone marrow drawn from iliac crest or other bone marrow cavity, cBMA applied clinically
Peripheral Blood Processing Device For Clinical Use
Preparation of autologous platelet rich plasma from a small sample of peripheral blood for clinical use
Uses centrifugal and/or filtration methods to separate the whole blood into components, after which the platelet rich plasma is withdrawn
Blood drawn from peripheral veins, PRP applied clinically
A laser product assembled or manufactured before August 1, 1976
A sunlamp product assembled or manufactured before november 9, 1979.  These are Class II medical devices as of 2014.
Test equipment using ultrasound to analyze an object for defects in commercial or industrial applications
Test equipment using ultrasound to determine thickness of material in commercial or industrial applications
Test equipment used to determine distance to an object using ultrasound in commercial or industrial applications
Equipment using ultrasound  to clean objects in commercial or industrial applications
Equipment used to weld objects  in commercial or industrial applications
Equipment using ultrasound to clean jewelry in commercial or household applications
Equipment using ultrasound to detect movement in commercial or household applications
Equipment using ultrasound to provide security in a commercial or household application
Equipment using ultrasound to repel pests in a commercial or household application
Equipment using ultrasound to provide massages in a household application that has no medical claims.
Equipment using ultrasound to disperse water droplets into an area in a household application
Photography equipment using ultrasound to provide range to subject
Equipment using ultrasound to provide security and an intrusion alarm in a commercial or household application
Equipment using ultrasound in research or scientific application
Equipment used to produce audible sound in household entertainment applications
Equipment used to produce a ring tone on a telephone
Equipment using ultrasound to diagnose disease in veterinary applications
Equipment using ultrasound to provide physical therapy in veterinary applications
An optical device that converts infrared radiation into a visible image through use of an image intensifier tube.
Vacuum tubes used in high voltage electronic circuits for purposes other than producing an image.
A vacuum tube generating a focused beam of electrons that can be deflected by electric fields, magnetic fields or both.
A vacuum tube used for switching high voltages.
A device that depicts on a screen periodic changes in an electric quantity, as voltage or current, using a cathode ray tube.
Television Receiver, Medical Imaging, Color
A television receiver using a color cathode ray tube to display medical images in colors.
Television Receiver, Medical Imaging, Monochrome
A television receiver using a monochrome cathode ray tube to display medical images in black and white with shades of gray or in different shades of one color.
Television Receiver, General Purpose, Color
An electronic product designed to receive and, using a color cathode ray tube, to display a television picture in colors from broadcast, cable, video disk player, video recorder, computer or closed circuit television signals.
Television Receiver, General Purpose, Monochrome
An electronic product designed to receive and, using a monochrome cathode ray tube, to display a television picture in black and white with shades of gray or in different shades of one color from broadcast, cable, video disk player, video recor
An electronic product using a color cathode ray tube to display medical images in colors from signals from a computer or electronic medical device.
An electronic product using a color cathode ray tube to display general images in colors from signals from a computer or electronic medical device.
Video Monitor, Medical Imaging, Monochrome
An electronic product using a monochrome cathode ray tube to display medical images in black and white with shades of gray or in different shades of one color from signals from a computer or electronic medical device.
Video Monitor, General Purpose, Monochrome
An electronic product using a monochrome cathode ray tube to display general images in black and white with shades of gray or in different shades of one color from signals from a computer or electronic medical device.
Electronic products that use a cathode ray tube or several cathode ray tubes to generate television images which are projected on a screen either from the front or from the rear.
An electronic product using a cathode ray tube to display the image seen through the lens of a camcorder.  To be exempt the cathode ray tube must operate under 5 kilovolts under the test conditions in the standard (phase iii).
An electronic device in which electron flow is produced and sustained by ionization of contained gas and ion bombardment of the cathode.
A betatron used for non-medical applications.
A cyclotron used for non-medical applications.
A microtron used for non-medical applications.
A synchrotron used for non-medical applications.
A linear accelerator used as a sterilizer for non-medical instruments and applications.
An accelerator used for industrial applications.
A linear accelerator used to non-intrusively search the contents of closed objects such as cargo containers or vehicles for contraband or weapons.
Diagnostic x-ray equipment or components manufactured before the dates specified in the applicability section in 21 cfr 1020.30(a).
An x-ray system used for industrial purposes to which the cabinet x-ray performance standard does not apply (21 cfr 1020.40).
an industrial x-ray system open on the bottom which is used on production lines to determine if containers are filled properly.
An open industrial x-ray system used to measure the thickness of material running through system, usually on a production line.
An open x-ray system which is used for non-intrusive inspection of containers suspected to contain bombs or other weapons or contraband.
An x-ray system used for x-ray diffraction and used in a laboratory environment.
An x-ray system used for x-ray spectroscopy and used in a laboratory environment.
An x-ray system for x-ray fluorescence and used in a laboratory environment.
A device which controls input power to the x-ray high-voltage generator and/or the x-ray tube. It includes equipment such as timers, phototimers, automatic brightness stabilizers, and similar devices which control the technique factors of an x-
shall mean the preselected portion of the device.
A cabinet x-ray system used for quality control,  non-destructive testing, or some other industrial purpose.
Cabinet X-Ray Explosive Detection Systems
A cabinet x-ray system used for detection of explosives in closed containers such as airline baggage.  Usually these systems use a non-standard x-ray mode to perform this function such as computed tomography.
Cabinet X-Ray, Security (Includes Baggage X-Ray)
A cabinet x-ray system used to examine the contents of containers such as airline baggage, brief cases, and purses to detect weapons or other contraband.
A large cabinet x-ray system used to examine pallets full of cargo to find weapons or other contraband, or a very large structure that encompasses entire vehicles being examined.
A device intended for the radiographic visualization and measurement of the dimensions of the human head.
A system that is uses x-radiation to visualize anatomical structures in veterinary applications.
Equipment using x-rays to provide therapy in veterinary applications.
An electronic system that implants ions for fabrication of semiconductor materials.
a particle beam system used to view objects or details too small to view with an optical microscope.
Personnel Security Backscatter X-Ray System
A system intended to find contraband, explosives, and weapons concealed under the clothing of a person through the use of backscattered x-rays.
Personnel Security Transmission X-Ray System
A system intended to find contraband, explosives, and weapons concealed under the clothing of a person or inside a person through the use of transmitted x-rays.
A mobile system, usually mounted in a truck or similar conveyance which uses x-rays to find contraband, explosives, or weapons concealed in vehicles and cargo containers.
Vehicle And Cargo X-Ray System, Stationary
A large system often in its own architectural structure, that does not encompass entire vehicles or cargo containers, which uses x-rays to find contraband, explosives, or weapons concealed in vehicles and cargo containers which pass through the
A machine that utilizes microwave radiation for food preparation, designed for home use.
A machine that utilizes microwave radiation for food preparation, designed for commercial establishments
A machine that utilizes microwave radiation for food preparation using a conveyorized or tunnel microwave waveguide.
A machine that utilizes microwave radiation for dispensing heated foods in public areas.
A machine that utilizes microwave radiation for food preparation, primarly used in commercial food industry
A machine that utilizes microwave radiation for industry drying/heating of non-food products (non-dielectric heater rf sealers)
A machine that utilizes microwave radiation to warm and dry clothing.
A machine that utilizes microwave radiation for treating or sterilizing medical waste.
A machine that utilizes microwave radiation for materials processing, custom designed or modified off-shelf for laboratories.
Dielectric Heaters, Induction Heaters, Rf Sealers
A machine that utilizes industrial radiofrequency (rf) induction heating with rf fields in frequency range from 2-500 mhz for industrial heating.
A machine that utilizes microwave or elf radiation in an electric blanket.
A machine that utilizes microwave or elf radiation for shaving hair.
A machine that utilizes microwave or elf radiation for drying hair.
A machine that utilizes microwave or elf radiation for fabric treatment, incorporated in a sewing machine.
A machine that utilizes microwave or elf radiation in a motor.
A machine that utilizes microwave radiation for veterinary treatments.
A machine that utilizes microwave radiation associated with identification, safety, security, or surveillance in the air traffic control environment.
A machine that utilizes microwave radiation associated with identification, safety, security, or surveillance in the police traffic control environment.
A machine that utilizes microwave radiation for rf id tags for security, tracking, inventory control, surveillance, etc.
A machine that utilizes microwave radiation used by retailers to prevent theft of merchandise or products
A machine that utilizes microwave radiation in a stun gun used by law enforcement and military.
A machine that utilizes microwave radiation (not eas or rfid) for security, tracking, inventory control, surveillance, etc.
A machine that utilizes microwave radiation for communication as in walkie talkies.
A machine that utilizes microwave radiation for communication and data transmission in a local area network.
A machine that utilizes microwave radiation for communication in a wireless, cordless telephone.
A machine that utilizes microwave radiation for communication in a cb amateur radio.
A machine that utilizes microwave radiation for data and measurement transmission in a weather doppler system.
A machine that utilizes microwave radiation for rf-excited lighting.
A machine that utilizes microwave radiation for pest control.
Automotive Accessory, Automobile Or Transport Vehicle
A laser product or product containing a laser that is an automotive or other transport vehicle accessory.
Product, laser, general, emit beam; A laser or product containing a laser that is intended for general purpose use.
High intensity mercury vapor discharge lamp that is designed, intended, or promoted for illumination purposes and manufactured after march 7, 1980.
High-intensity mercury vapor discharge lamp means any lamp including any mercury vapor or metal halide lamp, with the exception of tungsten filament self-ballasted mercury vapor lamp, incorporating a high pressure arc discharge tube that has a
Product, laser, demo, projector, laser light show/display, class iiia/3r and lower; Laser projection system that incorporates a laser having a maximum radiation output of less than 5mw.
Product, laser, demo, projector, laser light show/display, class iiib/iv/3b/4; Laser projection system that incorporates a laser having a maximum radiation output power greater than 5mw.
Product, laser, demo, laser light show/display, class iiib/iv/3b/4; Laser light show or demonstration using laser projection equipment having an output that exceeds 5mw
Product, laser, demo, projector, display, video; A laser used in conjunction or incorporated in a video display system or projector.
Product, laser, demo, system, display, advertising
Laser Visual Display - Display Retinal Image, Non-Medical
Product, laser, display, system, images, direct to retina
A bed or other platform that is designed to incorporate one or more ultraviolet lamps and intended for irradiation of any part of the human body, by ultraviolet radiation with wavelengths in air between 200 and 400 nanometers, to induce skin ta
A lamp that produces ultraviolet radiation in the wavelength range of 200 to 400 nanometers in air and that is intended for use in any sunlamp product or fixture.
A sunlamp system that sits on a table, primarily intended to tan the face by ultraviolet radiation with wavelengths in air between 200 and 400 nanometers.
Product, laser, demo, education, illustrate science principles
Product, laser, research/laboratory; A laser under development in and of itself.  A laser used for conducting  research during development of new data or to improve a process would not be considered a research laser although it is being used in
Product, laser, adaptive-optics telescope focusing accessory, generate artifical star; A laser used for alignment of optical telescopes.
Product, laser, instrument, spectroscopy; An instrument incorporating a laser for  spectroscopic testing or examination
Product, laser, instrument, particle size measurement; An instrument or system incorporating a laser for determining  the size or number of particles of particles a test sample.
Analytical Measuring And Detection Laser Product
Product, laser, instrument, analyze/detect chemical species
Product, laser, surveying, instrument, determine position by measurement of angles
Laser Time-Of-Flight Speed Measurement Products
Product, laser, measures speed by time-of-flight
Product, laser, alignment, aid positioning or adjusting parts in relation to each other
Product, laser, pointer, indicate point of interest; A laser product intended specifically to define a spot or surface for drawing attention to a viewer.
Product, laser, target designator; An optical devices, using a visible beam of laser light that permits the alignment of a gun, cannon or rocket system with its target.
Product, laser, aiming, visible, attached to weapon; An optical devices, using a visible beam of laser light that permits the alignment of a gun, cannon or rocket system with its target
Product, laser, aiming, infrared, attached to weapon, viewed with night-vision equipment; An optical devices, using an invisible beam of laser light that permits the alignment of a gun, cannon or rocket system with its target.
Ir Laser Illuminator With Alignment Aid/Night Vision System
Product, laser, infrared, illuminator with alignment aid, viewed through night-vision equipment
Ir Laser Illuminator Only/Night Vision System
Product, laser, infrared, illuminator only, viewed through night-vision equipment
Product, laser, infrared, collision-avoidance system
Ir Laser Intrusion Detection/Security System
Product, laser, infrared, intrusion detecting, security system
Laser Light Distance (Or Detection) And Ranging (Lidar)
Product, laser, for distance, detection or ranging measurement.
A high power laser intended to cut or drill a variety of materials in an industrial or commercial environment.
A high power laser intended to weld (join) materials in an industrial or commercial environment.
Microelectronic Mask Or Chip Processing, Checking, And/Or Repair
A laser intended to process, inspect, and/or repair microelectronic components in an industrial or commercial environment.
A laser intended to etch, engrave or otherwise create printer's plates used in an industrial or commercial environment.
A laser used for inspection, counting, or other application intended to monitor a part of the manufacturing process in an industrial or commercial environment.  Often incorporated in an automated process system.
A laser used for positioning, focusing, inspection, counting, or other application in an industrial or commercial environment.  Often incorporated in an automated assembly line system.
A laser used in high precision dimensional measurements in materials processing.
A laser used in precision positioning of materials in manufacturing in an industrial or commercial environment.
Fiber Optic Communication And Data Transfer
A laser used in fiber optic communications to transmit data and information.
Ir Free-Space Data Transmit/Control Laser
A laser used in free space (open air) communications to transmit data and information.
A laser used to transmit signals and/or information in order to operate equipment or machinery remotely.
A laser used as an interferometer for high precision positioning and/or measurements.
Product Incorporating Certified Class 1 Laser Data Measurement, Transmit, Control Product
A data measurement, data transmission, or remote control product that incorporates a certified class 1 laser.
A reprographics machine that incorporates a laser utilized to expose internal sensitive components or materials for photocopying text and graphics.
A printing machine that incorporates a laser utilized in printing images on paper.
A printing machine that incorporates a laser utilized in printing fascimilies of images on paper.
A cd or cd-rom player that utilizes a laser to read data on the compact disc.
A dvd, dvd-rom, bluray, or high definition (hd) player that utilizes a laser to read data on the digitally recorded video disc.
A cd-r or cd-rw recorder machine that utilizes a laser to read and/or write data on the compact disc.
A dvd, bluray, or hd recorder machine that utilizes a laser to read and write or read, write, and erase data on a digitally recorded video disc in any of the data formats: Dvd-r, dvd+r, dvd-ram, dvd-rw, or dvd+rw, or bluray or hd recorders or r
A laser used to scan across a bar code to identify the product.  Bar code readers can be hand-held accessories, under-counter components incorporated in store check-out systems, or laser scanner systems incorporated in assembly lines used for i
Product Incorporating Certified Class 1 Data Utility/Peripheral Laser Product
A utility/peripheral laser product that incorporates a certified class 1 laser.
A laser used for treatment of animals other than human
An ultraviolet wavelength noncoherent light source used for detection of counterfeit money.
An ultraviolet wavelength noncoherent light source used in crystallography for identification.
An ultraviolet wavelength noncoherent light source used in forensics for fingerprint detection.
An ultraviolet wavelength laser used in forensics for fingerprint detection.
An ultraviolet wavelength noncoherent light source used for sanitizing toilet seats.
An ultraviolet wavelength noncoherent light source used for sanitizing hands after washing.
An ultraviolet wavelength noncoherent light source used for sanitizing a countertop.
An ultraviolet wavelength noncoherent light source used for sanitizing towels in a towel washing process.
or causes a chemical reaction to change the material in a desired fashion. Typical materials are adhesives, plastics, potting compounds, etc.
An ultraviolet wavelength noncoherent light source used to illuminate a fluorescent material to produce fluorescence.
An ultraviolet wavelength noncoherent light source used to irradiate skin, nails, or hair for cosmetic purposes (excluding tanning).
An ultraviolet wavelength noncoherent light source used to sanitize water.
An ultraviolet wavelength noncoherent light source used to stimulate ultraviolet fluorescence.
X-Ray Field Indicator Light Field (Non-Laser)
A noncoherent light source incorporated in a diagnostic x-ray system that is irradiated onto the film screen area indicating the x-radiation area.  The beam is usually scanned to show a rectangular region for patient placement.
A noncoherent light source used in veterinary medicine.
A noncoherent ultraviolet or infrared light source used in research.
A general purpose fluorescent lamp used for illumination.
A noncoherent infrared light source used to detect motion to protect against intrusion.
A noncoherent infrared light source used for security.
A noncoherent infrared source used for data transmission or remote control of another product or machine.
High Pressure Mercury, Metal Halide, And Mercury Xenon Lamp (Not For General Purpose Illumination)
A high pressure mercury vapor, metal halide, or mercury xenon lamp used for a specific purpose and not intended for general purpose illumination.  Specific examples are lamps used in scientific and industrial equipment, projection televisions a
A noncoherent infrared light source used to transmit signals and/or information in order to operate equipment or machinery remotely.
A monitor or projector that uses a high intensity light source to illuminate pixels to produce images driven from a digital image source.
A broad spectrum output noncoherent light source intended for general purpose.
Mercury Vapor Lamp, Not Self-Extinguishing, R-Type
High intensity mercury vapor discharge lamp, not self-extinguishing, r lamp
Television, Less Than 25kv And Less Than 0.1 Mr/Hr
Television product, less than 25 kilovolt and less than 0.1 milliroentgen per hour
A laser intended to mark or engrave an object with text, logos, etc. Using either a mask or a scanned laser beam.
Non-surgical laser used on parts of the human body for non-medical uses.
Product, laser, image digitizer; Converts analog image into digital image format.
Fiber Optic Instrument For Testing Optical Fibers
A laser used in an instrument for testing and characterizing optical fibers.
Intended to amplify environmental sound for non-hearing impaired consumers
An ultraviolet wavelength noncoherent light source intended for use in general purpose, germicidal systems.
Hologram Displaying Or Creating Laser Product.
Laser product or product containing a laser that is for the creation or display of holograms for entertainment, artistic, or educational purposes.
Laser Holographic System For Experiments, Research, Or Prototype Development
A laser holographic system intended to be used for experimental or research purposes; May be prototypes for later manufacturing
A laser holographic system intended for measurement or process control in manufacturing, inspection, diagnosis or similar engineering activities
A mouse or trackball related to a computer or similar electronic tool, used to control the curser on the screen interface.
A mouse or trackball that incorporates a light emitting diode (led) to be used in relation to a computer or similar electronic tool, that controls the curser on the screen interface.
Uv noncoherent lamp product intended for consumer or commercial use; Including printing, reprographics, and other such processes
A sodium vapor lamp is a gas discharge lamp that uses sodium in an excited state to product light.  There are two varieties of such lamps: Low pressure and high pressure.  It is for general purpose illumination.
Laser wavefront sensing and/or topographic measurement sensor system.
A 3d laser scanning system to be used in an accurate free form process to capture physical objects and produce a complete digital representation of the object for applications such as reverse engineering, prototyping, design, modeling, or other
High intensity mercury vapor or metal halide lamp, intended for general purpose illumination, but of such a design that breakage of an outer envelope will not result in increased uv emissions.
Microscopy Laser Instrument Or Accessory Products
A laser product for microscopic studies of samples or a microscope laser accessory to assist in such microscopic studies.
Equipment used to cut objects in commercial or industrial applications.
A liquid crystal display (LCD) is a flat panel display that uses the light modulating properties of liquid crystal.
Laser product, visible wavelength, illuminator.
An electrical meter that records consumption of a consumable product delivered by a utility company and communicates wirelessly back to the utility company for monitoring and billing purposes.
A full-frame digital image projector which incorporates lasers and possibly other light sources to illuminate image processing components.
Any metal halide lamp, including sodium vapor, that does not incorporate a high-pressure arc discharge tube that has a fill consisting primarily of mercury and that is contained within an outer envelope.
Any scientific or research instrument that incorporates or uses any noncoherent light source.
A machine that utilizes microwave radiation for object detection and collision avoidance.
Television, Non-Crt, Non-Medical, Video Display
An electronic product designed to receive and display television or video signals from broadcast, cable, video player or recorder, computer, or other source.  This may be a receiver or monitor or similar.  This does not use a cathode ray tube (