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 |
|---|---|---|---|---|---|
| GEE | Brush, Biopsy, General & Plastic Surgery | Class I | 21 CFR 878.4800 | 7 | 0 |
| GEF | Applier, Staple, Surgical, | Class I | 21 CFR 878.4800 | 4 | 0 |
| GEG | Elevator, Surgical, General & Plastic Surgery | Class I | 21 CFR 878.4800 | 12 | 0 |
| GEH | Unit, Cryosurgical, Accessories | Class II | 21 CFR 878.4350 | 264 | 106 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | Class II | 21 CFR 878.4400 | 2,319 | 644 |
| GEJ | Carrier, Ligature | Class I | 21 CFR 878.4800 | 5 | 4 |
| GEN | Forceps, General & Plastic Surgery | Class I | 21 CFR 878.4800 | 104 | 10 |
| GEO | File, Surgical, General & Plastic Surgery | Class I | 21 CFR 878.4800 | 2 | 0 |
| GES | Blade, Scalpel | Class I | 21 CFR 878.4800 | 48 | 13 |
| GET | Motor, Surgical Instrument, Pneumatic Powered | Class I | 21 CFR 878.4820 | 23 | 54 |
| GEX | Powered Laser Surgical Instrument | Class II | 21 CFR 878.4810 | 2,887 | 201 |
| GEY | Motor, Surgical Instrument, Ac-Powered | Class I | 21 CFR 878.4820 | 41 | 27 |
| GFA | Blade, Saw, General & Plastic Surgery, Surgical | Class I | 21 CFR 878.4820 | 27 | 19 |
| GFB | Head, Surgical, Hammer | Class I | 21 CFR 878.4820 | 0 | 0 |
| GFC | Driver, Surgical, Pin | Class I | 21 CFR 878.4820 | 2 | 2 |
| GFD | Dermatome | Class I | 21 CFR 878.4820 | 12 | 22 |
| GFE | Brush, Dermabrasion, Powered | Class I | 21 CFR 878.4820 | 2 | 0 |
| GFF | Bur, Surgical, General & Plastic Surgery | Class I | 21 CFR 878.4820 | 16 | 13 |
| GFG | Bit, Surgical | Class I | 21 CFR 878.4820 | 3 | 17 |
| GFI | Osteotome, Manual | Class I | 21 CFR 878.4800 | 6 | 0 |
| GFJ | Mallet, Surgical, General & Plastic Surgery | Class I | 21 CFR 878.4800 | 3 | 2 |
| GFK | Fibrinogen Determination Standards And Controls | Class II | 21 CFR 864.7340 | 1 | 0 |
| GFO | Activated Partial Thromboplastin | Class II | 21 CFR 864.7925 | 52 | 10 |
| GFS | Standards And Controls, Hemoglobin, Normal And Abnormal | Class II | 21 CFR 864.8625 | 1 | 0 |
| GFT | Protamine Sulphate | Class II | 21 CFR 864.7525 | 2 | 0 |
| GFX | Fibrinogen Standard | Class II | 21 CFR 864.7340 | 3 | 0 |
| GGC | Control, Plasma, Abnormal | Class II | 21 CFR 864.5425 | 40 | 0 |
| GGF | Acid Hematin | Class II | 21 CFR 864.7500 | 0 | 0 |
| GGG | Guaiac Reagent | Class II | 21 CFR 864.6550 | 1 | 0 |
| GGH | Iron Stains | Class I | 21 CFR 864.1850 | 1 | 0 |
| GGJ | Fluid, Diluting, White-Cell | Class I | 21 CFR 864.8200 | 1 | 0 |
| GGK | Products, Red-Cell Lysing Products | Class I | 21 CFR 864.8540 | 29 | 7 |
| GGL | Control, White-Cell | Class II | 21 CFR 864.8625 | 8 | 0 |
| GGM | Control, Hemoglobin | Class II | 21 CFR 864.8625 | 15 | 2 |
| GGN | Plasma, Coagulation Control | Class II | 21 CFR 864.5425 | 99 | 16 |
| GGO | Reagent, Thromboplastin And Control | Class II | 21 CFR 864.7925 | 1 | 0 |
| GGP | Test, Qualitative And Quantitative Factor Deficiency | Class II | 21 CFR 864.7290 | 190 | 14 |
| GGQ | Test, Prothrombin Consumption | Class II | 21 CFR 864.7720 | 2 | 0 |
| GGT | Assay, Erythropoietin | Class II | 21 CFR 864.7250 | 20 | 5 |
| GGW | Test, Time, Partial Thromboplastin | Class II | 21 CFR 864.7925 | 32 | 4 |
| GGX | Pipette, Sahli | Class I | 21 CFR 864.6160 | 2 | 0 |
| GGY | Pipette, Diluting | Class I | 21 CFR 864.6160 | 0 | 0 |
| GGZ | Oxyhemoglobin | Class II | 21 CFR 864.7500 | 2 | 0 |
| GHA | Hemoglobin, Alkali Resistant | Class II | 21 CFR 864.7455 | 0 | 0 |
| GHC | Tube, Sedimentation Rate | Class I | 21 CFR 864.6700 | 1 | 1 |
| GHD | Test, Leukocyte Alkaline Phosphatase | Class I | 21 CFR 864.7660 | 4 | 0 |
| GHH | Fibrin Split Products | Class II | 21 CFR 864.7320 | 28 | 9 |
| GHK | Centrifuge, Microsedimentation | Class I | 21 CFR 864.5350 | 0 | 0 |
| GHM | Test, Sickle Cell | Class II | 21 CFR 864.7825 | 18 | 5 |
| GHO | Hemocytometer | Class I | 21 CFR 864.6160 | 2 | 0 |
| GHQ | Stain, Fetal Hemoglobin | Class II | 21 CFR 864.7455 | 2 | 1 |
| GHR | Reagent, Platelet Aggregation | Class II | 21 CFR 864.5700 | 11 | 2 |
| GHS | Assay, Carboxyhemoglobin | Class II | 21 CFR 864.7425 | 5 | 0 |
| GHY | Hematocrit, Tube, Rack, Sealer, Holder | Class II | 21 CFR 864.6400 | 2 | 0 |
| GHZ | Solution, Gugol Blue | Class I | 21 CFR 864.1850 | 0 | 0 |
| GIA | Test, Leukocyte Peroxidase | Class I | 21 CFR 864.7675 | 3 | 0 |
| GIE | Fibrometer | Class II | 21 CFR 864.5400 | 2 | 0 |
| GIF | Diluent, Blood Cell | Class I | 21 CFR 864.8200 | 38 | 13 |
| GIG | Hemoglobinometer | Class II | 21 CFR 864.7500 | 3 | 0 |
| GII | Glutathione, Red-Cell | Class II | 21 CFR 864.7375 | 0 | 0 |
| GIL | Plasma, Fibrinogen Control | Class II | 21 CFR 864.7340 | 8 | 0 |
| GIM | Tubes, Vacuum Sample, With Anticoagulant | Class II | 21 CFR 862.1675 | 39 | 9 |
| GIO | Tube, Collection, Capillary Blood | Class I | 21 CFR 864.6150 | 22 | 25 |
| GIQ | Hemoglobin S | Class II | 21 CFR 864.7415 | 3 | 0 |
| GIR | Reagent, Russel Viper Venom | Class I | 21 CFR 864.8950 | 16 | 1 |
| GIS | Test, Fibrinogen | Class II | 21 CFR 864.7340 | 13 | 0 |
| GIT | Reagent & Control, Partial Thromboplastin Time | Class II | 21 CFR 864.7925 | 4 | 0 |
| GIZ | Plasma, Control, Normal | Class II | 21 CFR 864.5425 | 20 | 1 |
| GJA | Test, Thrombin Time | Class II | 21 CFR 864.7875 | 20 | 4 |
| GJB | Thrombin | Class II | 21 CFR 864.7875 | 1 | 0 |
| GJC | Assay, Sulfhemoglobin | Class II | 21 CFR 864.7490 | 0 | 0 |
| GJE | Tray, Blood Collection | Class II | 21 CFR 862.1675 | 7 | 1 |
| GJG | Pipette, Quantitative, Hematology | Class I | 21 CFR 864.6160 | 4 | 0 |
| GJH | Stain, Reticulocyte | Class I | 21 CFR 864.1850 | 1 | 1 |
| GJJ | Stains, Heinz Body | Class I | 21 CFR 864.1850 | 0 | 0 |
| GJL | Romanowsky Stains | Class I | 21 CFR 864.1850 | 1 | 0 |
| GJN | Fluid, Diluting, Red-Cell | Class I | 21 CFR 864.8200 | 0 | 0 |
| GJP | Control, Platelet | Class II | 21 CFR 864.8625 | 4 | 0 |
| GJR | Control, Red-Cell | Class II | 21 CFR 864.8625 | 5 | 0 |
| GJS | Test, Time, Prothrombin | Class II | 21 CFR 864.7750 | 127 | 73 |
| GJT | Plasma, Coagulation Factor Deficient | Class II | 21 CFR 864.7290 | 79 | 3 |
| GJW | Pipette, Pasteur | Class I | 21 CFR 864.6160 | 4 | 0 |
| GJZ | Cyanomethemoglobin Reagent And Standard Solution | Class II | 21 CFR 864.7500 | 2 | 0 |
| GKA | Abnormal Hemoglobin Quantitation | Class II | 21 CFR 864.7415 | 23 | 10 |
| GKB | Device, Automated Sedimentation Rate | Class I | 21 CFR 864.5800 | 2 | 3 |
| GKE | Osmotic Fragility Testing | Class I | 21 CFR 864.6600 | 0 | 2 |
| GKF | Instrument, Hematocrit, Automated | Class II | 21 CFR 864.5600 | 15 | 1 |
| GKG | Centrifuge, Hematocrit | Class II | 21 CFR 864.6400 | 11 | 4 |
| GKH | Apparatus, Automated Blood Cell Diluting | Class I | 21 CFR 864.5240 | 14 | 2 |
| GKJ | Spinner, Slide, Automated | Class I | 21 CFR 864.5850 | 6 | 1 |
| GKK | Cyanomethemoglobin | Class II | 21 CFR 864.7500 | 7 | 0 |
| GKL | Counter, Cell, Automated (Particle Counter) | Class II | 21 CFR 864.5200 | 130 | 10 |
| GKM | Hand-Tally, Differential | Class I | 21 CFR 864.6160 | 4 | 0 |
| GKN | Timer, Clot, Automated | Class II | 21 CFR 864.5400 | 3 | 0 |
| GKP | Instrument, Coagulation, Automated | Class II | 21 CFR 864.5400 | 49 | 31 |
| GKQ | Test, Thromboplastin Generation | Class I | 21 CFR 864.7900 | 1 | 0 |
| GKR | System, Hemoglobin, Automated | Class II | 21 CFR 864.5620 | 39 | 8 |
| GKT | Separator, Automated, Blood Cell, Diagnostic | Class II | 21 CFR 864.9245 | 10 | 1 |
| GKW | Aggregometer, Platelet, Thrombokinetogram | Class II | 21 CFR 864.6675 | 0 | 0 |
| GKX | Instrument, Automated Platelet Counting | Class II | 21 CFR 864.5200 | 2 | 0 |
