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 |
|---|---|---|---|---|---|
| GXB | Esthesiometer | Class I | 21 CFR 882.1500 | 7 | 0 |
| GXC | Device, Electroconvulsive Therapy | Class III | 21 CFR 882.5940 | 0 | 0 |
| GXD | Generator, Lesion, Radiofrequency | Class II | 21 CFR 882.4400 | 37 | 7 |
| GXE | Leukotome | Class I | 21 CFR 882.4600 | 1 | 1 |
| GXH | Device, Surgical, Cryogenic | Class II | 21 CFR 882.4250 | 23 | 2 |
| GXI | Probe, Radiofrequency Lesion | Class II | 21 CFR 882.4725 | 66 | 29 |
| GXJ | Punch, Skull | Class I | 21 CFR 882.4750 | 0 | 0 |
| GXL | Screwdriver, Skullplate | Class I | 21 CFR 882.4900 | 0 | 2 |
| GXM | Anvil, Skull Plate | Class I | 21 CFR 882.4030 | 0 | 0 |
| GXN | Plate, Cranioplasty, Preformed, Non-Alterable | Class II | 21 CFR 882.5330 | 57 | 11 |
| GXO | Strip, Craniosynostosis, Preformed | Class II | 21 CFR 882.5900 | 2 | 0 |
| GXP | Methyl Methacrylate For Cranioplasty | Class II | 21 CFR 882.5300 | 45 | 30 |
| GXQ | Dura Substitute | Class II | 21 CFR 882.5910 | 43 | 23 |
| GXR | Cover, Burr Hole | Class II | 21 CFR 882.5250 | 29 | 1 |
| GXS | Monitor, Alpha | Class II | 21 CFR 882.1610 | 0 | 0 |
| GXT | Monitor, Lesion Temperature | Class II | 21 CFR 882.5500 | 0 | 0 |
| GXW | Echoencephalograph | Class II | 21 CFR 882.1240 | 7 | 0 |
| GXX | Block, Test, Ultrasonic Scanner Calibration | Class I | 21 CFR 882.1925 | 3 | 0 |
| GXY | Electrode, Cutaneous | Class II | 21 CFR 882.1320 | 440 | 20 |
| GXZ | Electrode, Needle | Class II | 21 CFR 882.1350 | 53 | 21 |
| GYA | Tester, Electrode/Lead, Electroencephalograph | Class I | 21 CFR 882.1410 | 5 | 0 |
| GYB | Media, Electroconductive | Class II | 21 CFR 882.1275 | 69 | 10 |
| GYC | Electrode, Cortical | Class II | 21 CFR 882.1310 | 32 | 6 |
| GYD | Transducer, Tremor | Class II | 21 CFR 882.1950 | 15 | 0 |
| GYE | Encephalogram Telemetry System | Class II | 21 CFR 882.1855 | 20 | 0 |
| GYK | Instrument, Shunt System Implantation | Class I | 21 CFR 882.4545 | 13 | 1 |
| GYZ | Stimulator, Intracerebral/Subcortical, Implanted | Class III | 21 CFR 882.5840 | 0 | 0 |
| GZA | Implanted Cerebellar Stimulator | Class III | 21 CFR 882.5820 | 0 | 0 |
| GZB | Stimulator, Spinal-Cord, Implanted (Pain Relief) | Class II | 21 CFR 882.5880 | 139 | 5 |
| GZC | Stimulator, Neuromuscular, Implanted | Class III | 21 CFR 882.5860 | 0 | 1 |
| GZD | Stimulator, Spinal-Cord, Implanted, For Bladder Evacuation | Class III | 21 CFR 882.5850 | 0 | 0 |
| GZE | Implanted Diaphragmatic/Phrenic Nerve Stimulator | Class III | 21 CFR 882.5830 | 0 | 0 |
| GZF | Stimulator, Peripheral Nerve, Implanted (Pain Relief) | Class II | 21 CFR 882.5870 | 25 | 7 |
| GZI | Stimulator, Neuromuscular, External Functional | Class II | 21 CFR 882.5810 | 61 | 2 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | Class II | 21 CFR 882.5890 | 606 | 7 |
| GZK | Electrode, Nasopharyngeal | Class II | 21 CFR 882.1340 | 2 | 0 |
| GZL | Electrode, Depth | Class II | 21 CFR 882.1330 | 58 | 24 |
| GZM | Analyzer, Rigidity | Class II | 21 CFR 882.1020 | 0 | 0 |
| GZN | Rheoencephalograph | Class III | 21 CFR 882.1825 | 0 | 0 |
| GZO | Device, Galvanic Skin Response Measurement | Class II | 21 CFR 882.1540 | 26 | 3 |
| GZP | Stimulator, Mechanical, Evoked Response | Class II | 21 CFR 882.1880 | 2 | 0 |
| GZQ | Instrument, Dowel Cutting | Class II | 21 CFR 882.4275 | 1 | 0 |
| GZT | Retractor, Self-Retaining, For Neurosurgery | Class II | 21 CFR 882.4800 | 44 | 6 |
| GZX | Instrument, Microsurgical | Class I | 21 CFR 882.4525 | 13 | 1 |
| HAB | Saw, Powered, And Accessories | Class I | 21 CFR 878.4820 | 2 | 16 |
| HAD | Rongeur, Powered | Class II | 21 CFR 882.4845 | 3 | 0 |
| HAE | Rongeur, Manual | Class II | 21 CFR 882.4840 | 37 | 2 |
| HAM | Apparatus, Electrosurgical | Class II | 21 CFR 878.4400 | 31 | 3 |
| HAO | Instrument, Surgical, Non-Powered | Class I | 21 CFR 882.4535 | 34 | 2 |
| HAS | Needle, Neurosurgical Suture | Class I | 21 CFR 882.4650 | 0 | 0 |
| HAW | Neurological Stereotaxic Instrument | Class II | 21 CFR 882.4560 | 425 | 197 |
| HAX | Tong, Skull For Traction | Class II | 21 CFR 882.5960 | 20 | 13 |
| HBA | Neurosurgical Paddie | Class II | 21 CFR 882.4700 | 24 | 78 |
| HBB | Motor, Drill, Pneumatic | Class II | 21 CFR 882.4370 | 27 | 18 |
| HBC | Motor, Drill, Electric | Class II | 21 CFR 882.4360 | 27 | 39 |
| HBD | Handpiece (Brace), Drill | Class I | 21 CFR 882.4325 | 0 | 0 |
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | Class II | 21 CFR 882.4310 | 65 | 258 |
| HBF | Drills, Burrs, Trephines & Accessories (Compound, Powered) | Class II | 21 CFR 882.4305 | 19 | 6 |
| HBG | Drills, Burrs, Trephines & Accessories (Manual) | Class II | 21 CFR 882.4300 | 17 | 54 |
| HBI | Illuminator, Fiberoptic, Surgical Field | Class II | 21 CFR 878.4580 | 28 | 0 |
| HBK | Chair, Pneumoencephalographic | Class II | 21 CFR 892.1820 | 0 | 0 |
| HBL | Holder, Head, Neurosurgical (Skull Clamp) | Class II | 21 CFR 882.4460 | 50 | 14 |
| HBM | Headrest, Neurosurgical | Class I | 21 CFR 882.4440 | 3 | 2 |
| HBN | Chair, Neurosurgical | Class I | 21 CFR 882.4125 | 4 | 0 |
| HBO | Clip, Scalp | Class II | 21 CFR 882.4150 | 11 | 3 |
| HBP | Clip, Implanted Malleable | Class II | 21 CFR 882.5225 | 0 | 0 |
| HBQ | Instrument, Clip Removal | Class I | 21 CFR 882.4200 | 0 | 0 |
| HBR | Rack, Clip | Class I | 21 CFR 882.4215 | 1 | 0 |
| HBS | Instrument, Clip Forming/Cutting | Class I | 21 CFR 882.4190 | 0 | 0 |
| HBT | Applier, Hemostatic Clip | Class I | 21 CFR 878.4800 | 4 | 14 |
| HBW | Fastener, Plate, Cranioplasty | Class II | 21 CFR 882.5360 | 7 | 1 |
| HBX | Instrument, Cranioplasty Material Forming | Class I | 21 CFR 882.4500 | 0 | 3 |
| HBZ | Catheter, Intravascular Occluding | Class III | 21 CFR 882.5150 | 0 | 0 |
| HCA | Catheter, Ventricular | Class II | 21 CFR 882.4100 | 10 | 6 |
| HCB | Device, Aversive Conditioning | Class II | 21 CFR 882.5235 | 6 | 0 |
| HCC | Device, Biofeedback | Class II | 21 CFR 882.5050 | 172 | 4 |
| HCD | Cannula, Ventricular | Class I | 21 CFR 882.4060 | 3 | 0 |
| HCE | Clamp, Carotid Artery | Class II | 21 CFR 882.5175 | 2 | 0 |
| HCF | Instrument, Ligature Passing And Knot Tying | Class I | 21 CFR 878.4800 | 5 | 5 |
| HCG | Device, Neurovascular Embolization | Class II | 21 CFR 882.5950 | 187 | 68 |
| HCH | Clip, Aneurysm | Class II | 21 CFR 882.5200 | 36 | 4 |
| HCI | Applier, Aneurysm Clip | Class II | 21 CFR 882.4175 | 14 | 5 |
| HCJ | Device, Skin Potential Measurement | Class II | 21 CFR 882.1560 | 2 | 0 |
| HCS | Device, Temperature Measurement, Direct Contact, Powered | Class II | 21 CFR 882.1570 | 8 | 0 |
| HCY | Curette, Uterine | Class I | 21 CFR 884.4530 | 11 | 1 |
| HCZ | Forceps, Surgical, Gynecological | Class II | 21 CFR 884.4530 | 24 | 0 |
| HDA | Forceps, Obstetrical | Class II | 21 CFR 884.4400 | 10 | 7 |
| HDB | Extractor, Vacuum, Fetal | Class II | 21 CFR 884.4340 | 30 | 6 |
| HDC | Tenaculum, Uterine | Class II | 21 CFR 884.4530 | 20 | 8 |
| HDD | Table, Obstetrical, Ac-Powered (And Accessories) | Class II | 21 CFR 884.4900 | 7 | 8 |
| HDE | Hook, Fibroid, Gynecological | Class I | 21 CFR 884.4520 | 0 | 0 |
| HDF | Speculum, Vaginal, Metal | Class I | 21 CFR 884.4520 | 11 | 3 |
| HDG | Speculum, Vaginal, Metal, Fiberoptic | Class I | 21 CFR 884.4520 | 2 | 0 |
| HDH | Needle, Cerclage, Gynecological | Class I | 21 CFR 884.4530 | 0 | 0 |
| HDI | Hook, Destructive, Obstetrical | Class II | 21 CFR 884.4500 | 0 | 0 |
| HDJ | Scissors, Umbilical | Class I | 21 CFR 884.4520 | 1 | 0 |
| HDK | Scissors, Episiotomy | Class I | 21 CFR 884.4520 | 0 | 0 |
| HDL | Retractor, Vaginal | Class I | 21 CFR 884.4520 | 2 | 1 |
| HDM | Packer, Uterine | Class I | 21 CFR 884.4520 | 0 | 0 |
| HDN | Dilator, Cervical, Expandable | Class III | 21 CFR 884.4250 | 0 | 0 |
