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 |
|---|---|---|---|---|---|
| HRN | Unit, Cryophthalmic, Ac-Powered | Class II | 21 CFR 886.4170 | 10 | 0 |
| HRO | Unit, Electrolysis, Ac-Powered, Ophthalmic | Class II | 21 CFR 886.4250 | 0 | 0 |
| HRP | Pen, Marking, Surgical | Class I | 21 CFR 886.4570 | 0 | 0 |
| HRQ | Hemostat | Class I | 21 CFR 878.4800 | 15 | 3 |
| HRR | Scissors, Orthopedic, Surgical | Class I | 21 CFR 888.4540 | 8 | 1 |
| HRS | Plate, Fixation, Bone | Class II | 21 CFR 888.3030 | 1,327 | 286 |
| HRT | Stripper, Surgical | Class I | 21 CFR 888.4540 | 0 | 0 |
| HRW | Dynamometer, Nonpowered | Class I | 21 CFR 888.1250 | 12 | 0 |
| HRX | Arthroscope | Class II | 21 CFR 888.1100 | 683 | 126 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | Class II | 21 CFR 888.3530 | 91 | 68 |
| HRZ | Prosthesis, Knee, Hinged (Metal-Metal) | Class III | 21 CFR 888.3480 | 0 | 0 |
| HSA | Prosthesis, Knee, Hemi-, Femoral | Class III | 21 CFR 888.3570 | 0 | 0 |
| HSB | Rod, Fixation, Intramedullary And Accessories | Class II | 21 CFR 888.3020 | 531 | 690 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | Class II | 21 CFR 888.3690 | 71 | 19 |
| HSH | Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented) | Class II | 21 CFR 888.3590 | 5 | 0 |
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | Class II | 21 CFR 888.3110 | 68 | 47 |
| HSO | Saw | Class I | 21 CFR 878.4800 | 0 | 0 |
| HSP | Splint, Traction | Class I | 21 CFR 888.5890 | 1 | 1 |
| HSQ | Belt, Pelvic, Traction | Class I | 21 CFR 888.5890 | 1 | 0 |
| HSR | Unit, Traction, Hip, Non-Powered, Non-Penetrating | Class I | 21 CFR 888.5890 | 1 | 0 |
| HSS | Halter, Head, Traction | Class I | 21 CFR 888.5890 | 3 | 0 |
| HST | Apparatus, Traction, Non-Powered | Class I | 21 CFR 888.5850 | 38 | 11 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Class II | 21 CFR 888.3520 | 115 | 104 |
| HSZ | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | Class I | 21 CFR 878.4820 | 56 | 6 |
| HTC | Pliers, Surgical | Class I | 21 CFR 878.4800 | 10 | 4 |
| HTD | Forceps | Class I | 21 CFR 878.4800 | 73 | 14 |
| HTE | Elevator | Class I | 21 CFR 878.4800 | 0 | 3 |
| HTF | Curette | Class I | 21 CFR 878.4800 | 3 | 2 |
| HTG | Prosthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented | Class II | 21 CFR 888.3580 | 2 | 0 |
| HTH | Protractor | Class I | 21 CFR 888.4600 | 3 | 0 |
| HTJ | Gauge, Depth | Class I | 21 CFR 888.4300 | 4 | 3 |
| HTM | Stimulator, Osteogenesis, Electric, Battery-Operated, Invasive | Class III | 0 | 0 | |
| HTN | Washer, Bolt Nut | Class II | 21 CFR 888.3030 | 93 | 4 |
| HTO | Reamer | Class I | 21 CFR 888.4540 | 14 | 83 |
| HTP | File | Class I | 21 CFR 888.4540 | 5 | 0 |
| HTQ | Broach | Class I | 21 CFR 888.4540 | 0 | 5 |
| HTR | Rasp | Class I | 21 CFR 878.4800 | 9 | 2 |
| HTS | Knife, Orthopedic | Class I | 21 CFR 888.4540 | 9 | 3 |
| HTT | Burr, Orthopedic | Class I | 21 CFR 888.4540 | 4 | 23 |
| HTW | Bit, Drill | Class I | 21 CFR 888.4540 | 11 | 114 |
| HTX | Rongeur | Class I | 21 CFR 888.4540 | 5 | 7 |
| HTY | Pin, Fixation, Smooth | Class II | 21 CFR 888.3040 | 205 | 32 |
| HTZ | Instrument, Cutting, Orthopedic | Class I | 21 CFR 878.4800 | 21 | 27 |
| HWA | Impactor | Class I | 21 CFR 888.4540 | 4 | 27 |
| HWB | Extractor | Class I | 21 CFR 888.4540 | 5 | 4 |
| HWC | Screw, Fixation, Bone | Class II | 21 CFR 888.3040 | 1,068 | 388 |
| HWD | Starter, Bone Screw | Class I | 21 CFR 888.4540 | 0 | 1 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | Class I | 21 CFR 878.4820 | 76 | 101 |
| HWF | Prosthesis, Ligament | Class III | 0 | 0 | |
| HWI | Corkscrew | Class I | 21 CFR 888.4540 | 1 | 0 |
| HWJ | Awl | Class I | 21 CFR 888.4540 | 4 | 26 |
| HWK | Trephine | Class I | 21 CFR 888.4540 | 1 | 0 |
| HWL | Set, Hollow Mill | Class I | 21 CFR 888.4540 | 0 | 0 |
| HWM | Osteotome | Class I | 21 CFR 878.4800 | 3 | 0 |
| HWN | Instrument, Compression | Class I | 21 CFR 888.4540 | 4 | 9 |
| HWO | Skid, Bone | Class I | 21 CFR 888.4540 | 0 | 0 |
| HWP | Punch, Femoral Neck | Class I | 21 CFR 888.4540 | 1 | 0 |
| HWQ | Passer | Class I | 21 CFR 888.4540 | 9 | 8 |
| HWR | Driver, Prosthesis | Class I | 21 CFR 888.4540 | 4 | 6 |
| HWT | Template | Class I | 21 CFR 888.4800 | 10 | 85 |
| HWW | Countersink | Class I | 21 CFR 888.4540 | 0 | 17 |
| HWX | Tap, Bone | Class I | 21 CFR 888.4540 | 2 | 15 |
| HXA | Prosthesis, Tendon, Passive | Class II | 21 CFR 888.3025 | 11 | 0 |
| HXB | Probe | Class I | 21 CFR 888.4540 | 15 | 3 |
| HXC | Wrench | Class I | 21 CFR 888.4540 | 6 | 8 |
| HXD | Clamp | Class I | 21 CFR 878.4800 | 14 | 4 |
| HXE | Fork | Class I | 21 CFR 888.4540 | 0 | 0 |
| HXG | Tamp | Class I | 21 CFR 888.4540 | 1 | 0 |
| HXI | Passer, Wire, Orthopedic | Class I | 21 CFR 888.4540 | 3 | 8 |
| HXJ | Staple Driver | Class I | 21 CFR 888.4540 | 6 | 2 |
| HXK | Holder, Needle; Orthopedic | Class I | 21 CFR 888.4540 | 5 | 5 |
| HXL | Mallet | Class I | 21 CFR 878.4800 | 3 | 1 |
| HXN | Applier, Cerclage | Class I | 21 CFR 888.4540 | 2 | 0 |
| HXO | Pusher, Socket | Class I | 21 CFR 888.4540 | 3 | 1 |
| HXP | Instrument, Bending Or Contouring | Class I | 21 CFR 888.4540 | 5 | 1 |
| HXQ | Crimper, Pin | Class I | 21 CFR 888.4540 | 0 | 1 |
| HXR | Spatula, Orthopedic | Class I | 21 CFR 878.4800 | 4 | 0 |
| HXS | Twister, Wire | Class I | 21 CFR 888.4540 | 2 | 2 |
| HXT | Tape, Orthopedic | Class I | 21 CFR 878.4800 | 0 | 0 |
| HXW | Bender | Class I | 21 CFR 888.4540 | 3 | 3 |
| HXX | Screwdriver | Class I | 21 CFR 888.4540 | 4 | 32 |
| HXY | Brace, Drill | Class I | 21 CFR 888.4540 | 7 | 1 |
| HXZ | Cutter, Wire | Class I | 21 CFR 888.4540 | 1 | 1 |
| HYA | Forceps, Wire Holding | Class I | 21 CFR 878.4800 | 0 | 1 |
| HYB | Eosin Y | Class I | 21 CFR 864.1850 | 10 | 3 |
| HYC | Fast Green | Class I | 21 CFR 864.1850 | 1 | 0 |
| HYD | Fast Red Salt B | Class I | 21 CFR 864.1850 | 1 | 0 |
| HYE | Solution, Fontanna Silver | Class I | 21 CFR 864.1850 | 0 | 0 |
| HYF | Giemsa Stain | Class I | 21 CFR 864.1850 | 4 | 1 |
| HYG | Glenner'S Stain | Class I | 21 CFR 864.1850 | 1 | 0 |
| HYH | Gold Chloride | Class I | 21 CFR 864.1850 | 0 | 0 |
| HYI | Iodine, Grams | Class I | 21 CFR 864.1850 | 6 | 0 |
| HYJ | Hematoxylin | Class I | 21 CFR 864.1850 | 14 | 1 |
| HYK | Hematoxylin Harris'S | Class I | 21 CFR 864.1850 | 7 | 0 |
| HYL | Hematoxylin Mayer'S | Class I | 21 CFR 864.1850 | 0 | 0 |
| HYO | Hematoxylin Weigert'S | Class I | 21 CFR 864.1850 | 1 | 0 |
| HYQ | Iron Chloride-Weigert | Class I | 21 CFR 864.1850 | 0 | 0 |
| HYR | Leuco-Patent Blue | Class I | 21 CFR 864.1850 | 0 | 0 |
| HYS | Light Green | Class I | 21 CFR 864.1850 | 1 | 0 |
| HYT | Luxol Fast Blue | Class I | 21 CFR 864.1850 | 0 | 0 |
