FDA product codes
The device classification tree, in product code order.
FDA classifies every device type under a three-letter product code, and that code is what ties a clearance to a recall to a registered listing. Each page here carries the FDA definition, the regulation it sits under, clearance volume by year, and the companies that list the code with FDA.
Data as of , the FDA export date. FDA product classification database
Review panels
6,880 codes| Review panel | Panel code | Product codes |
|---|---|---|
| Anesthesiology | AN | 262 |
| Cardiovascular | CV | 437 |
| Clinical Chemistry | CH | 527 |
| Clinical Toxicology | TX | 338 |
| Dental | DE | 352 |
| Ear, Nose, Throat | EN | 269 |
| Gastroenterology, Urology | GU | 614 |
| General Hospital | HO | 394 |
| General, Plastic Surgery | SU | 562 |
| Hematology | HE | 281 |
| Immunology | IM | 278 |
| Medical Genetics | MG | 7 |
| Microbiology | MI | 554 |
| Neurology | NE | 291 |
| Obstetrics/Gynecology | OB | 269 |
| Ophthalmic | OP | 345 |
| Orthopedic | OR | 349 |
| Pathology | PA | 325 |
| Physical Medicine | PM | 210 |
| Radiology | RA | 216 |
| Code | Device name | Class | Regulation | Clearances | Recalls |
|---|---|---|---|---|---|
| FQK | Binder, Perineal | Class I | 21 CFR 880.5160 | 0 | 0 |
| FQL | Stocking, Medical Support (For General Medical Purposes) | Class I | 21 CFR 880.5780 | 6 | 2 |
| FQM | Bandage, Elastic | Class I | 21 CFR 880.5075 | 42 | 30 |
| FQO | Table, Operating-Room, Ac-Powered | Class I | 21 CFR 878.4960 | 35 | 73 |
| FQP | Lamp, Operating-Room | Class II | 21 CFR 878.4580 | 5 | 0 |
| FQZ | Thermometer, Clinical Color Change | Class I | 21 CFR 880.2900 | 14 | 2 |
| FRA | Purifier, Air, Ultraviolet, Medical | Class II | 21 CFR 880.6500 | 36 | 0 |
| FRC | Indicator, Biological Sterilization Process | Class II | 21 CFR 880.2800 | 206 | 40 |
| FRF | Cleaner, Air, Medical Recirculating | Class II | 21 CFR 880.5045 | 53 | 1 |
| FRG | Wrap, Sterilization | Class II | 21 CFR 880.6850 | 323 | 50 |
| FRI | Scale, Stand-On, Patient | Class I | 21 CFR 880.2700 | 3 | 2 |
| FRJ | Chair, Geriatric | Class I | 21 CFR 880.6140 | 0 | 1 |
| FRK | Chair, Examination And Treatment | Class I | 21 CFR 880.6140 | 4 | 1 |
| FRL | Fiber, Medical, Absorbent | Class I | 21 CFR 880.5300 | 19 | 6 |
| FRN | Pump, Infusion | Class II | 21 CFR 880.5725 | 849 | 721 |
| FRO | Dressing, Wound, Drug | Unclassified | 709 | 82 | |
| FRP | Holder, Infant Position | Class I | 21 CFR 880.5680 | 14 | 0 |
| FRQ | Tube, Levine | Class II | 21 CFR 876.5980 | 3 | 0 |
| FRR | Chamber, Reverse Isolation, Patient Care | Class II | 21 CFR 880.5450 | 1 | 0 |
| FRT | Unit, Isolation, Surgical | Class II | 21 CFR 878.5070 | 0 | 0 |
| FRW | Scale, Patient | Class I | 21 CFR 880.2720 | 48 | 7 |
| FRZ | Device, Patient Transfer, Powered | Class II | 21 CFR 880.6775 | 5 | 2 |
| FSA | Lift, Patient, Non-Ac-Powered | Class I | 21 CFR 880.5510 | 13 | 141 |
| FSD | Binder, Abdominal | Class I | 21 CFR 880.5160 | 5 | 0 |
| FSE | Table, Operating-Room, Manual | Class I | 21 CFR 878.4950 | 13 | 1 |
| FSH | Tray, Surgical, Needle | Class I | 21 CFR 878.4800 | 8 | 7 |
| FSM | Tray, Surgical, Instrument | Class I | 21 CFR 878.4800 | 76 | 36 |
| FSO | Microscope, Surgical, General & Plastic Surgery | Class I | 21 CFR 878.4700 | 15 | 17 |
| FSP | Loupe, Diagnostic/Surgical | Class I | 21 CFR 878.4800 | 4 | 3 |
| FSQ | Light, Surgical, Instrument | Class II | 21 CFR 878.4580 | 7 | 0 |
| FSR | Light, Headband, Surgical | Class II | 21 CFR 886.4335 | 4 | 0 |
| FSS | Light, Surgical, Floor Standing | Class II | 21 CFR 878.4580 | 20 | 0 |
| FST | Light, Surgical, Fiberoptic | Class II | 21 CFR 878.4580 | 45 | 12 |
| FSW | Light, Surgical, Endoscopic | Class II | 21 CFR 878.4580 | 8 | 0 |
| FSX | Light, Surgical, Connector | Class II | 21 CFR 878.4580 | 0 | 0 |
| FSY | Light, Surgical, Ceiling Mounted | Class II | 21 CFR 878.4580 | 74 | 454 |
| FSZ | Light, Surgical, Carrier | Class II | 21 CFR 878.4580 | 0 | 0 |
| FTA | Light, Surgical, Accessories | Class II | 21 CFR 878.4580 | 26 | 5 |
| FTC | Light, Ultraviolet, Dermatological | Class II | 21 CFR 878.4630 | 272 | 15 |
| FTD | Lamp, Surgical | Class II | 21 CFR 878.4580 | 29 | 49 |
| FTF | Illuminator, Non-Remote | Class II | 21 CFR 878.4580 | 4 | 0 |
| FTG | Illuminator, Remote | Class II | 21 CFR 878.4580 | 2 | 0 |
| FTH | Camera, Still, Microsurgical | Class I | 21 CFR 878.4160 | 0 | 0 |
| FTI | Lamp, Endoscope, Incandescent | Class II | 21 CFR 876.1500 | 2 | 0 |
| FTJ | Colonoscope, General & Plastic Surgery | Class II | 21 CFR 876.1500 | 0 | 0 |
| FTL | Mesh, Surgical, Polymeric | Class II | 21 CFR 878.3300 | 336 | 73 |
| FTM | Mesh, Surgical | Class II | 21 CFR 878.3300 | 164 | 76 |
| FTN | Plastic Surgery And Accessories Kit | Class I | 21 CFR 878.3925 | 0 | 63 |
| FTO | Prosthesis, Testicle | Class III | 21 CFR 876.3750 | 0 | 0 |
| FTQ | Prosthesis, Penis, Rigid Rod | Class II | 21 CFR 876.3630 | 2 | 0 |
| FTR | Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled | Class III | 21 CFR 878.3540 | 0 | 14 |
| FTS | Camera, Cine, Endoscopic, With Audio | Class I | 21 CFR 878.4160 | 2 | 0 |
| FTT | Camera, Still, Surgical | Class I | 21 CFR 878.4160 | 1 | 0 |
| FTX | Mirror, General & Plastic Surgery | Class I | 21 CFR 878.4800 | 1 | 0 |
| FTY | Tape, Measuring, Rulers And Calipers | Class I | 21 CFR 878.4800 | 23 | 5 |
| FTZ | Locator, Magnetic | Class I | 21 CFR 886.4445 | 2 | 0 |
| FWB | Camera, Television, Surgical, Without Audio | Class I | 21 CFR 878.4160 | 6 | 2 |
| FWC | Camera, Television, Surgical, With Audio | Class I | 21 CFR 878.4160 | 3 | 0 |
| FWD | Camera, Television, Microsurgical, Without Audio | Class I | 21 CFR 878.4160 | 5 | 0 |
| FWE | Camera, Television, Microsurgical, With Audio | Class I | 21 CFR 878.4160 | 0 | 1 |
| FWF | Camera, Television, Endoscopic, Without Audio | Class I | 21 CFR 878.4160 | 23 | 2 |
| FWG | Camera, Television, Endoscopic, With Audio | Class I | 21 CFR 878.4160 | 2 | 0 |
| FWH | Camera, Cine, Surgical, Without Audio | Class I | 21 CFR 878.4160 | 2 | 1 |
| FWI | Camera, Cine, Surgical, With Audio | Class I | 21 CFR 878.4160 | 0 | 0 |
| FWJ | Camera, Cine, Microsurgical, Without Audio | Class I | 21 CFR 878.4160 | 0 | 1 |
| FWK | Camera, Cine, Microsurgical, With Audio | Class I | 21 CFR 878.4160 | 0 | 0 |
| FWL | Camera, Cine, Endoscopic, Without Audio | Class I | 21 CFR 878.4160 | 2 | 0 |
| FWM | Prosthesis, Breast, Inflatable, Internal, Saline | Class III | 21 CFR 878.3530 | 0 | 9 |
| FWN | Prosthesis, Larynx (Stents And Keels) | Class II | 21 CFR 874.3620 | 10 | 1 |
| FWP | Prosthesis, Chin, Internal | Class II | 21 CFR 878.3550 | 66 | 5 |
| FWW | Table, Operating-Room, Pneumatic | Class I | 21 CFR 878.4960 | 6 | 0 |
| FWX | Table, Operating-Room, Mechanical | Class I | 21 CFR 878.4950 | 3 | 1 |
| FWY | Table, Operating-Room, Non-Electrical | Class I | 21 CFR 878.4950 | 4 | 0 |
| FWZ | Operating Room Accessories Table Tray | Class I | 21 CFR 878.4950 | 61 | 37 |
| FXE | Speculum, Non-Illuminated | Class I | 21 CFR 878.1800 | 0 | 0 |
| FXF | Speculum, Illuminated | Class I | 21 CFR 878.1800 | 1 | 0 |
| FXG | Specula Accessories | Class I | 21 CFR 878.1800 | 1 | 1 |
| FXM | Camera, Still, Endoscopic | Class I | 21 CFR 878.4160 | 1 | 5 |
| FXN | Tape, Camera, Surgical | Class I | 21 CFR 878.4160 | 4 | 0 |
| FXO | Suit, Surgical | Class I | 21 CFR 878.4040 | 6 | 0 |
| FXP | Cover, Shoe, Operating-Room | Class I | 21 CFR 878.4040 | 36 | 0 |
| FXQ | Lens, Camera, Surgical | Class I | 21 CFR 878.4160 | 1 | 0 |
| FXR | Holder, Camera, Surgical | Class I | 21 CFR 878.4160 | 2 | 0 |
| FXS | Frame, Camera, Surgical | Class I | 21 CFR 878.4160 | 0 | 0 |
| FXT | Film, Camera, Surgical | Class I | 21 CFR 878.4160 | 0 | 0 |
| FXW | Shoes, Operating-Room | Class I | 21 CFR 878.4040 | 1 | 0 |
| FXX | Mask, Surgical | Class II | 21 CFR 878.4040 | 607 | 12 |
| FXY | Hood, Surgical | Class II | 21 CFR 878.4040 | 13 | 3 |
| FXZ | Helmet, Surgical | Class I | 21 CFR 878.4040 | 0 | 0 |
| FYA | Gown, Surgical | Class II | 21 CFR 878.4040 | 298 | 129 |
| FYB | Gown, Patient | Class II | 21 CFR 878.4040 | 6 | 0 |
| FYC | Gown, Isolation, Surgical | Class II | 21 CFR 878.4040 | 68 | 2 |
| FYD | Apparatus, Exhaust, Surgical | Class II | 21 CFR 878.5070 | 75 | 23 |
| FYE | Dress, Surgical | Class I | 21 CFR 878.4040 | 7 | 1 |
| FYF | Cap, Surgical | Class I | 21 CFR 878.4040 | 32 | 0 |
| FYH | Splint, Extremity, Noninflatable, External, Sterile | Class I | 21 CFR 878.3910 | 8 | 0 |
| FYI | Appliance, Facial Fracture, External | Class I | 21 CFR 878.3250 | 4 | 0 |
| FZC | Prosthesis, Arterial Graft, Bovine Carotid Artery | Class III | 0 | 0 | |
| FZD | Prosthesis, Ear, Internal | Class II | 21 CFR 878.3590 | 3 | 0 |
| FZE | Prosthesis, Nose, Internal | Class II | 21 CFR 878.3680 | 42 | 0 |
