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 |
|---|---|---|---|---|---|
| HDO | Valve, Tubal Occlusion | Class III | 21 CFR 884.5380 | 0 | 0 |
| HDP | Elevator, Uterine | Class II | 21 CFR 884.4530 | 4 | 0 |
| HDQ | Dilator, Cervical, Fixed Size | Class I | 21 CFR 884.4530 | 6 | 4 |
| HDR | Cap, Cervical | Class II | 21 CFR 884.5250 | 29 | 0 |
| HDT | Device, Intrauterine, Contraceptive And Introducer | Class III | 21 CFR 884.5360 | 0 | 0 |
| HDW | Diaphragm, Contraceptive (And Accessories) | Class II | 21 CFR 884.5350 | 4 | 3 |
| HDX | Dilator, Vaginal | Class II | 21 CFR 884.3900 | 9 | 1 |
| HDY | Dilator, Cervical, Hygroscopic-Laminaria | Class II | 21 CFR 884.4260 | 11 | 0 |
| HDZ | Knife, Cervical Cone | Class II | 21 CFR 884.4530 | 0 | 0 |
| HEB | Tampon, Menstrual, Unscented | Class II | 21 CFR 884.5470 | 189 | 36 |
| HEC | Insufflator, Vaginal | Class I | 21 CFR 884.5920 | 0 | 0 |
| HED | Douche Apparatus, Vaginal, Therapeutic | Class I | 21 CFR 884.5900 | 12 | 0 |
| HEE | Set, Anesthesia, Paracervical | Class II | 21 CFR 884.5100 | 9 | 1 |
| HEF | Binder, Breast | Class I | 21 CFR 880.5160 | 0 | 0 |
| HEG | Set, Anesthesia, Pudendal | Class II | 21 CFR 884.5100 | 0 | 0 |
| HEH | Chamber, Decompression, Abdominal | Class III | 21 CFR 884.5225 | 0 | 0 |
| HEI | Monitor, Heart-Valve Movement, Fetal, Ultrasonic | Class II | 21 CFR 884.2660 | 3 | 0 |
| HEJ | Monitor, Hemic Sound, Ultrasonic | Class II | 21 CFR 884.2660 | 0 | 0 |
| HEK | Monitor, Heart Sound, Fetal, Ultrasonic | Class II | 21 CFR 884.2660 | 5 | 0 |
| HEL | Monitor, Heart Rate, Fetal, Ultrasonic | Class II | 21 CFR 884.2660 | 7 | 0 |
| HEM | Imager, Ultrasonic Obstetric-Gynecologic | Class II | 21 CFR 884.2225 | 30 | 1 |
| HEN | Caliper, Fetal Head, Ultrasonic | Class II | 21 CFR 884.2225 | 0 | 0 |
| HEO | Analyzer, Data, Obstetric | Class III | 21 CFR 884.2050 | 0 | 0 |
| HEP | Monitor, Blood-Flow, Ultrasonic | Class II | 21 CFR 884.2660 | 4 | 0 |
| HEQ | Monitor, Pressure, Arterial, Fetal, Ultrasonic | Class II | 21 CFR 884.2660 | 0 | 0 |
| HER | Pelvimeter, External | Class I | 21 CFR 884.4520 | 0 | 0 |
| HES | Insufflator, Carbon-Dioxide, Uterotubal (And Accessories) | Class II | 21 CFR 884.1300 | 13 | 0 |
| HET | Laparoscope, Gynecologic (And Accessories) | Class II | 21 CFR 884.1720 | 338 | 19 |
| HEW | Culdoscope (And Accessories) | Class II | 21 CFR 884.1640 | 18 | 4 |
| HEX | Colposcope (And Colpomicroscope) | Class II | 21 CFR 884.1630 | 56 | 0 |
| HEZ | Endoscope, Transcervical (Amnioscope)(And Accessories) | Class II | 21 CFR 884.1660 | 0 | 0 |
| HFA | Amnioscope, Transabdominal (Fetoscope) (And Accessories) | Humanitarian device exemption | 21 CFR 884.1600 | 0 | 0 |
| HFB | Forceps, Biopsy, Gynecological | Class I | 21 CFR 884.4530 | 22 | 1 |
| HFC | Aspirator, Endocervical | Class II | 21 CFR 884.1050 | 11 | 0 |
| HFD | Washer, Endometrial | Class II | 21 CFR 884.1185 | 3 | 0 |
| HFE | Brush, Endometrial | Class II | 21 CFR 884.1100 | 9 | 1 |
| HFF | Aspirator, Endometrial | Class II | 21 CFR 884.1060 | 5 | 0 |
| HFG | Coagulator, Laparoscopic, Unipolar (And Accessories) | Class II | 21 CFR 884.4160 | 11 | 0 |
| HFH | Coagulator, Hysteroscopic (And Accessories) | Class II | 21 CFR 884.4160 | 0 | 0 |
| HFI | Coagulator, Culdoscopic (And Accessories) | Class II | 21 CFR 884.4160 | 8 | 0 |
| HFJ | Prosthesis, Fallopian Tube | Class II | 21 CFR 884.3650 | 1 | 0 |
| HFK | Mold, Vaginal | Class II | 21 CFR 884.3900 | 1 | 0 |
| HFL | Drain, Cervical | Class II | 21 CFR 884.3200 | 1 | 0 |
| HFM | Monitor, Uterine Contraction, External (For Use In Clinic) | Class II | 21 CFR 884.2720 | 23 | 8 |
| HFN | Transducer, Pressure, Intrauterine | Class II | 21 CFR 884.2700 | 9 | 1 |
| HFO | Recorder, Pressure, Intrauterine | Class II | 21 CFR 884.2700 | 4 | 0 |
| HFP | Monitor, Phonocardiographic, Fetal | Class II | 21 CFR 884.2640 | 0 | 0 |
| HFS | Shield, Nipple | Class I | 21 CFR 880.5630 | 12 | 1 |
| HFW | Clamp, Umbilical | Class II | 21 CFR 884.4530 | 36 | 1 |
| HFX | Clamp, Circumcision | Class II | 21 CFR 884.4530 | 27 | 14 |
| HFY | Band, Tubal Occlusion | Class III | 21 CFR 884.5380 | 0 | 0 |
| HFZ | Craniotribe | Class II | 21 CFR 884.4500 | 0 | 0 |
| HGA | Cranioclast | Class II | 21 CFR 884.4500 | 0 | 0 |
| HGB | Clip, Tubal Occlusion | Class III | 21 CFR 884.5380 | 0 | 2 |
| HGC | Clamp, Uterine | Class I | 21 CFR 884.4520 | 2 | 11 |
| HGD | Applicator, Vaginal | Class I | 21 CFR 884.4520 | 1 | 2 |
| HGE | Amniotome | Class I | 21 CFR 884.4530 | 6 | 0 |
| HGF | Source, Abortion Unit, Vacuum | Class II | 21 CFR 884.5070 | 4 | 0 |
| HGG | Controller, Abortion Unit, Vacuum | Class II | 21 CFR 884.5070 | 1 | 0 |
| HGH | Cannula, Suction, Uterine | Class II | 21 CFR 884.5070 | 6 | 0 |
| HGI | Electrocautery, Gynecologic (And Accessories) | Class II | 21 CFR 884.4120 | 53 | 24 |
| HGK | Endoscope, Fetal Blood Sampling (And Accessories) | Class II | 21 CFR 884.1660 | 1 | 0 |
| HGL | Transducer, Ultrasonic, Obstetric | Class II | 21 CFR 884.2960 | 36 | 4 |
| HGM | System, Monitoring, Perinatal | Class II | 21 CFR 884.2740 | 215 | 28 |
| HGN | Stethoscope, Fetal | Class I | 21 CFR 884.2900 | 2 | 0 |
| HGO | Monitor, Electroencephalographic, Fetal (And Accessories) | Class III | 21 CFR 884.2620 | 0 | 0 |
| HGP | Electrode, Circular (Spiral), Scalp And Applicator | Class II | 21 CFR 884.2675 | 17 | 3 |
| HGS | Catheter, Intrauterine And Introducer | Class II | 21 CFR 884.2700 | 2 | 1 |
| HGW | Sampler, Blood, Fetal | Class II | 21 CFR 884.1560 | 4 | 0 |
| HGX | Pump, Breast, Powered | Class II | 21 CFR 884.5160 | 253 | 8 |
| HGY | Pump, Breast, Non-Powered | Class I | 21 CFR 884.5150 | 27 | 2 |
| HGZ | Heater, Perineal, Direct Contact | Class II | 21 CFR 884.5390 | 1 | 0 |
| HHA | Heater, Perineal, Radiant, Non-Contact | Class II | 21 CFR 884.5390 | 0 | 0 |
| HHD | Pad, Menstrual, Unscented | Class I | 21 CFR 884.5435 | 136 | 0 |
| HHE | Cup, Menstrual | Class II | 21 CFR 884.5400 | 16 | 0 |
| HHF | Remover, Intrauterine Device, Contraceptive, Hook-Type | Class I | 21 CFR 884.4530 | 6 | 1 |
| HHG | Dilator, Cervical, Vibratory | Class III | 21 CFR 884.4270 | 0 | 0 |
| HHI | System, Abortion, Vacuum | Class II | 21 CFR 884.5070 | 24 | 2 |
| HHJ | Locator, Intracorporeal Device, Ultrasonic, Obstetric-Gynecologic | Class II | 21 CFR 884.2225 | 1 | 0 |
| HHK | Curette, Suction, Endometrial (And Accessories) | Class II | 21 CFR 884.1175 | 42 | 3 |
| HHL | Pad, Menstrual, Scented, Scented-Deodorized | Class II | 21 CFR 884.5425 | 57 | 0 |
| HHM | Sound, Uterine | Class I | 21 CFR 884.4530 | 10 | 4 |
| HHN | Cleidoclast | Class II | 21 CFR 884.4500 | 0 | 0 |
| HHO | Screw, Fibroid, Gynecological | Class II | 21 CFR 884.4530 | 2 | 0 |
| HHP | Table, Obstetrical, Manual (And Accessories) | Class II | 21 CFR 884.4900 | 2 | 0 |
| HHQ | System, Abortion, Metreurynter-Balloon | Class III | 21 CFR 884.5050 | 0 | 0 |
| HHR | Laser, Surgical, Gynecologic | Class II | 21 CFR 884.4550 | 48 | 0 |
| HHS | Transcervical Contraceptive Tubal Occlusion Device | Class III | 21 CFR 884.5380 | 0 | 0 |
| HHT | Spatula, Cervical, Cytological | Class II | 21 CFR 884.4530 | 73 | 0 |
| HHW | Pessary, Vaginal | Class II | 21 CFR 884.3575 | 41 | 17 |
| HHX | Holograph, Fetal, Acoustical | Class II | 21 CFR 884.2225 | 0 | 0 |
| HHY | Prosthesis, Suture, Cerclage | Class III | 0 | 0 | |
| HIB | Speculum, Vaginal, Nonmetal | Class II | 21 CFR 884.4530 | 72 | 6 |
| HIC | Speculum, Vaginal, Nonmetal, Fiberoptic | Class II | 21 CFR 884.4530 | 5 | 0 |
| HIF | Insufflator, Laparoscopic | Class II | 21 CFR 884.1730 | 179 | 29 |
| HIG | Insufflator, Hysteroscopic | Class II | 21 CFR 884.1700 | 57 | 6 |
| HIH | Hysteroscope (And Accessories) | Class II | 21 CFR 884.1690 | 175 | 16 |
| HII | Stimulator, Vaginal, Muscle, Powered, For Therapeutic Use | Class III | 21 CFR 884.5940 | 0 | 0 |
| HIL | Tampon, Menstrual, Scented, Scented-Deodorized | Class II | 21 CFR 884.5460 | 84 | 0 |
| HIM | Electrocautery, Endoscopic And Accessories | Class II | 21 CFR 884.4100 | 0 | 0 |
