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 |
|---|---|---|---|---|---|
| EMG | Forceps, Tooth Extractor, Surgical | Class I | 21 CFR 872.4565 | 10 | 1 |
| EMH | Forceps, Rongeur, Surgical | Class I | 21 CFR 872.4565 | 8 | 0 |
| EMI | File, Bone, Surgical | Class I | 21 CFR 872.4565 | 4 | 4 |
| EMJ | Elevator, Surgical, Dental | Class I | 21 CFR 872.4565 | 6 | 0 |
| EMK | Curette, Surgical, Dental | Class I | 21 CFR 872.4565 | 1 | 0 |
| EML | Chisel, Bone, Surgical | Class I | 21 CFR 872.4565 | 2 | 0 |
| EMM | Chisel, Osteotome, Surgical | Class I | 21 CFR 872.4565 | 4 | 1 |
| EMN | Scaler, Periodontic | Class I | 21 CFR 872.4565 | 5 | 0 |
| EMO | Knife, Periodontic | Class I | 21 CFR 872.4565 | 0 | 1 |
| EMP | Marker, Periodontic | Class I | 21 CFR 872.4565 | 0 | 0 |
| EMQ | Hoe, Periodontic | Class I | 21 CFR 872.4565 | 0 | 0 |
| EMR | File, Periodontic | Class I | 21 CFR 872.4565 | 1 | 0 |
| EMS | Curette, Periodontic | Class I | 21 CFR 872.4565 | 7 | 0 |
| EMX | Balloon, Epistaxis | Class I | 21 CFR 874.4100 | 47 | 4 |
| ENW | Catheter, Nasopharyngeal | Class I | 21 CFR 874.4175 | 2 | 0 |
| ENZ | Telescope, Laryngeal-Bronchial | Class II | 21 CFR 874.4680 | 3 | 0 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | Class II | 21 CFR 874.4760 | 163 | 8 |
| EOQ | Bronchoscope (Flexible Or Rigid) | Class II | 21 CFR 874.4680 | 244 | 160 |
| EOX | Esophagoscope (Flexible Or Rigid) | Class II | 21 CFR 874.4710 | 30 | 8 |
| EPE | Brush, Cleaning, Tracheal Tube | Class I | 21 CFR 868.5795 | 2 | 1 |
| EPF | Hearing Aid, Group And Auditory Trainer | Class II | 21 CFR 874.3320 | 32 | 0 |
| EPG | Stimulator, Transdermal | Class III | 0 | 0 | |
| EPN | Pump, Nebulizer, Manual | Class I | 21 CFR 874.5220 | 2 | 0 |
| EPP | Splint, Nasal | Class I | 21 CFR 874.5800 | 15 | 2 |
| EPT | Microscope, Surgical | Class I | 21 CFR 878.4700 | 18 | 14 |
| EPW | Support, Head, Surgical, Ent | Class I | 21 CFR 878.4950 | 2 | 0 |
| EPY | Speculum, Ent | Class I | 21 CFR 878.1800 | 12 | 2 |
| EQH | Source, Carrier, Fiberoptic Light | Class I | 21 CFR 874.4350 | 49 | 1 |
| EQJ | Bur, Ear, Nose And Throat | Class I | 21 CFR 874.4140 | 18 | 4 |
| EQL | Laryngostroboscope | Class I | 21 CFR 874.4750 | 8 | 2 |
| EQN | Laryngoscope, Nasopharyngoscope | Class II | 21 CFR 874.4760 | 22 | 2 |
| ERA | Otoscope | Class I | 21 CFR 874.4770 | 56 | 1 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | Class II | 21 CFR 874.4250 | 91 | 29 |
| ERY | Drape, Surgical, Ent | Class II | 21 CFR 878.4370 | 0 | 0 |
| ESD | Hearing Aid, Air-Conduction, Prescription | Class I | 21 CFR 874.3300 | 1,367 | 4 |
| ESE | Larynx, Artificial (Battery-Powered) | Class I | 21 CFR 874.3375 | 13 | 0 |
| ESF | Polymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent | Class II | 21 CFR 878.3500 | 2 | 0 |
| ESH | Polymer, Ent Synthetic-Pife, Silicon Elastomer, Polyethylene, Polyurethane | Class II | 21 CFR 874.3620 | 1 | 0 |
| ESI | Polymer, Natural-Absorbable Gelatin Material | Class III | 2 | 0 | |
| ESW | Prosthesis, Esophageal | Class II | 21 CFR 878.3610 | 60 | 67 |
| ESX | Tack, Sacculotomy (Cody Tack) | Class II | 21 CFR 874.3760 | 1 | 0 |
| ESZ | Tube, Shunt, Endolymphatic | Class II | 21 CFR 874.3820 | 4 | 0 |
| ETA | Replacement, Ossicular Prosthesis, Total | Class II | 21 CFR 874.3495 | 39 | 2 |
| ETB | Prosthesis, Partial Ossicular Replacement | Class II | 21 CFR 874.3450 | 74 | 3 |
| ETC | Mold, Middle-Ear | Class II | 21 CFR 874.3430 | 1 | 0 |
| ETD | Tube, Tympanostomy | Class II | 21 CFR 874.3880 | 116 | 14 |
| ETF | Unit, Examining/Treatment, Ent | Class I | 21 CFR 874.5300 | 32 | 0 |
| ETK | Tube, Toynbee Diagnostic | Class I | 21 CFR 874.1925 | 1 | 0 |
| ETM | Gustometer, Sterile | Class I | 21 CFR 874.1500 | 0 | 0 |
| ETN | Stimulator, Nerve | Class II | 21 CFR 874.1820 | 97 | 31 |
| ETP | Stimulator, Caloric-Water | Class I | 21 CFR 874.1800 | 6 | 2 |
| ETR | Adaptor, Short Increment Sensitivity Index (Sisi) | Class I | 21 CFR 874.1070 | 0 | 0 |
| ETS | Generator, Electronic Noise (For Audiometric Testing) | Class II | 21 CFR 874.1120 | 5 | 0 |
| ETT | Cushion, Earphone (For Audiometric Testing) | Class I | 21 CFR 874.1100 | 0 | 0 |
| ETW | Calibrator, Hearing Aid / Earphone And Analysis Systems | Class II | 21 CFR 874.3310 | 46 | 0 |
| ETY | Tester, Auditory Impedance | Class II | 21 CFR 874.1090 | 70 | 1 |
| EWA | Set, Audiometer Calibration | Class I | 21 CFR 874.1080 | 2 | 0 |
| EWC | Chamber, Acoustic (For Audiometric Testing) | Class I | 21 CFR 874.1060 | 2 | 0 |
| EWD | Protector, Hearing (Insert) | Unclassified | 14 | 0 | |
| EWE | Protector, Hearing (Circumaural) | Unclassified | 1 | 0 | |
| EWG | Laser, Ent Microsurgical Carbon-Dioxide | Class II | 21 CFR 874.4500 | 24 | 0 |
| EWL | Prosthesis, Laryngeal (Taub) | Class II | 21 CFR 874.3730 | 40 | 4 |
| EWO | Audiometer | Class II | 21 CFR 874.1050 | 235 | 5 |
| EWQ | Saw, Surgical, Ent (Electric Or Pneumatic) | Class I | 21 CFR 874.4420 | 2 | 0 |
| EWT | Device, Antichoke, Suction | Class III | 21 CFR 874.5350 | 0 | 0 |
| EWW | Device, Antichoke, Tongs | Class III | 21 CFR 874.5370 | 0 | 0 |
| EWY | Mediastinoscope, Surgical | Class II | 21 CFR 874.4720 | 11 | 0 |
| EXA | Selector, Size, Ostomy | Class I | 21 CFR 876.5900 | 1 | 0 |
| EXB | Collector, Ostomy | Class I | 21 CFR 876.5900 | 102 | 5 |
| EXD | Irrigator, Ostomy | Class II | 21 CFR 876.5895 | 12 | 0 |
| EXE | Protector, Ostomy | Class I | 21 CFR 876.5900 | 3 | 4 |
| EXF | Bag, Bile Collecting | Class II | 21 CFR 876.5010 | 9 | 3 |
| EXG | Bag, Urine Collecting, Ureterostomy | Class I | 21 CFR 876.5900 | 0 | 1 |
| EXH | Bag, Urinary, Ileostomy | Class I | 21 CFR 876.5900 | 0 | 0 |
| EXI | Device, Paste-On For Incontinence, Sterile | Class I | 21 CFR 876.5250 | 7 | 0 |
| EXJ | Device, Incontinence, Urosheath Type, Sterile | Class I | 21 CFR 876.5250 | 22 | 0 |
| EXM | Truss, Umbilical | Class I | 21 CFR 876.5970 | 0 | 0 |
| EXN | Support, Hernia | Class I | 21 CFR 876.5970 | 1 | 0 |
| EXQ | Cystometer, Electrical Recording | Class II | 21 CFR 876.1620 | 8 | 1 |
| EXR | Urinometer, Mechanical | Class II | 21 CFR 876.1800 | 9 | 0 |
| EXS | Urinometer, Electrical | Class II | 21 CFR 876.1800 | 0 | 6 |
| EXW | Pill, Radio | Class II | 21 CFR 876.1725 | 1 | 0 |
| EXX | Probe, Rectal, Non-Powered | Class I | 21 CFR 876.4730 | 0 | 1 |
| EXY | Uroflowmeter | Class II | 21 CFR 876.1800 | 16 | 2 |
| EXZ | Equipment, Photographic, For Physiologic Function Monitor | Class I | 21 CFR 876.1500 | 0 | 0 |
| EYA | Stylet, Ureteral | Class I | 21 CFR 876.5130 | 0 | 0 |
| EYB | Catheter, Ureteral, Gastro-Urology | Class II | 21 CFR 876.5130 | 28 | 4 |
| EYC | Catheter, Upper Urinary Tract | Class II | 21 CFR 876.5130 | 5 | 0 |
| EYD | Stirrups | Class I | 21 CFR 876.4890 | 0 | 0 |
| EYF | Protector, Wound, Plastic | Class I | 21 CFR 878.4014 | 5 | 0 |
| EYH | Table, Cysto, Non-Electrical | Class I | 21 CFR 876.4890 | 0 | 0 |
| EYI | Adaptor, Ureteral Catheter | Class I | 21 CFR 876.5130 | 0 | 0 |
| EYJ | Holder, Ureteral Catheter | Class I | 21 CFR 876.5130 | 0 | 0 |
| EYK | Connector, Ureteral Catheter | Class I | 21 CFR 876.5130 | 1 | 0 |
| EYN | Tray, Irrigation, Sterile | Class II | 21 CFR 876.5980 | 15 | 3 |
| EYQ | Garment, Protective, For Incontinence | Class I | 21 CFR 876.5920 | 56 | 0 |
| EYR | Tourniquet, Gastro-Urology | Class I | 21 CFR 878.5900 | 2 | 0 |
| EYS | Ribdam | Class I | 21 CFR 876.4560 | 0 | 0 |
| EYT | Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile | Class I | 21 CFR 876.5250 | 4 | 0 |
| EYX | Drape, Pure Latex Sheet, With Self-Retaining Finger Cot | Class II | 21 CFR 878.4370 | 1 | 0 |
