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 |
|---|---|---|---|---|---|
| MXD | Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) | Class II | 21 CFR 870.1025 | 34 | 10 |
| MXF | System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation | Class II | 21 CFR 872.4120 | 5 | 0 |
| MXG | Lamp, Uvc, (For Treating Skin And Wounds) | Class II | 21 CFR 878.4630 | 1 | 1 |
| MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | Class II | 21 CFR 866.3305 | 20 | 0 |
| MXK | Device, Analysis, Anterior Segment | Class II | 21 CFR 886.1850 | 23 | 7 |
| MXM | Cap, Cooling (Infants) | Class III | 0 | 2 | |
| MXO | Laser, System, Phacolysis | Class II | 21 CFR 886.4670 | 0 | 0 |
| MXP | Bone Particle Collector | Class I | 21 CFR 874.4800 | 0 | 3 |
| MXQ | Stent, Urethral, External Sphincter, Permanent | Class III | 0 | 0 | |
| MXT | Device, Accessory, Cooling Plate For Tissue Embedding Station | Class I | 21 CFR 864.3010 | 0 | 0 |
| MXW | Suture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride) | Class II | 21 CFR 878.5010 | 2 | 0 |
| MXY | Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal | Class I | 21 CFR 886.4350 | 0 | 3 |
| MXZ | Immunohistochemistry Assay, Antibody, Progesterone Receptor | Class II | 21 CFR 864.1860 | 13 | 3 |
| MYA | Immunohistochemistry Antibody Assay, Estrogen Receptor | Class II | 21 CFR 864.1860 | 12 | 3 |
| MYB | Pillow, Cervical (For Mild Sleep Apnea) | Class II | 21 CFR 872.5570 | 6 | 0 |
| MYC | Ophthalmoscope, Laser, Scanning | Class II | 21 CFR 886.1570 | 23 | 0 |
| MYD | Keratome, Water Jet | Class I | 21 CFR 886.4370 | 1 | 0 |
| MYE | System, Electrogastrography (Egg) | Class II | 21 CFR 876.1735 | 9 | 0 |
| MYF | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 | Class II | 21 CFR 866.3305 | 10 | 2 |
| MYH | System, Non-Coherent Light, Photodynamic Therapy | Class III | 0 | 0 | |
| MYI | System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies | Class II | 21 CFR 866.1640 | 10 | 0 |
| MYJ | Device, Mixing And Weighing, Semi-Automated | Class II | 21 CFR 864.9195 | 0 | 0 |
| MYK | Kit, Cord Blood Collection | Not classified | 0 | 0 | |
| MYL | Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg | Class III | 0 | 3 | |
| MYM | Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm | Class III | 0 | 1 | |
| MYN | Analyzer, Medical Image | Class II | 21 CFR 892.2070 | 40 | 3 |
| MYP | Test, Platelet Antibody | Class II | 0 | 0 | |
| MYR | Test, Donor, Syphilis, Antigens, Treponemal | Class II | 21 CFR 866.3830 | 0 | 0 |
| MYS | Device, Ahf, Automated Cryoprecipitation | Not classified | 0 | 0 | |
| MYT | Biosensor, Immunoassay, Cpk Or Isoenzymes | Class II | 21 CFR 862.1215 | 3 | 1 |
| MYU | Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty | Class II | 21 CFR 882.5300 | 6 | 0 |
| MYW | Irradiation, Blood Indicators | Not classified | 0 | 0 | |
| MYX | System, Blood Collection, Vacuum-Assisted, Automated | Class I | 21 CFR 864.9125 | 0 | 0 |
| MYY | Separator, Semi-Automated, Blood Component | Class I | 0 | 0 | |
| MYZ | Kit, Test (Donors), For Bloodborne Pathogen | Class II | 0 | 0 | |
| MZA | Test, Equipment, Automated Bloodborne Pathogen | Not classified | 0 | 3 | |
| MZC | System, Detection, Bacterial, For Platelet Transfusion Products | Class I | 21 CFR 866.2560 | 0 | 0 |
| MZD | System, In-Office Tinting, Contact Lenses | Class II | 21 CFR 886.5925 | 1 | 0 |
| MZE | Test, Donor, Cmv | Class II | 0 | 0 | |
| MZF | Test, Hiv Detection | Class II | 21 CFR 866.3956 | 0 | 1 |
| MZG | Test, Residual, Wbc In Leukoreduced Blood | Class II | 21 CFR 864.8625 | 0 | 0 |
| MZH | Test, Quantitative, For Hla, Non-Diagnostic | Not classified | 0 | 0 | |
| MZI | Test, Qualitative, For Hla, Non-Diagnostic | Unclassified | 0 | 0 | |
| MZK | System, Separation, Hematopoietic Stem Cell | Class III | 0 | 0 | |
| MZL | Kit, Test, Quality Control For Endotoxin | Not classified | 0 | 0 | |
| MZM | Fibrin Sealant Preparation Device | Class II | 21 CFR 880.5860 | 0 | 0 |
| MZO | Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus | Class II | 21 CFR 866.3169 | 3 | 7 |
| MZP | Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus | Class II | 21 CFR 866.3170 | 4 | 11 |
| MZQ | Balloon, Detachable, For Neurovascular Occlusion | Class II | 21 CFR 882.5950 | 2 | 0 |
| MZR | Topical Approximation System | Class I | 21 CFR 880.5240 | 0 | 0 |
| MZT | Device, Heimlich Maneuver Assist | Class II | 21 CFR 868.5115 | 1 | 0 |
| MZU | System, Test, Sodium, Enzymatic Method | Class II | 21 CFR 862.1665 | 2 | 0 |
| MZV | Test, System, Potassium, Enzymatic Method | Class II | 21 CFR 862.1600 | 4 | 0 |
| MZW | Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief | Class II | 21 CFR 872.3275 | 2 | 3 |
| MZY | Graft, Vascular, Stainless Steel Tunneler | Class II | 21 CFR 870.3450 | 0 | 0 |
| NAA | Lens, Intraocular, Accommodative | Class III | 21 CFR 886.3600 | 0 | 1 |
| NAB | Gauze / Sponge,Nonresorbable For External Use | Class I | 21 CFR 878.4014 | 88 | 6 |
| NAC | Dressing, Wound, Hydrophilic | Class I | 21 CFR 878.4018 | 4 | 9 |
| NAD | Dressing, Wound, Occlusive | Class I | 21 CFR 878.4020 | 108 | 19 |
| NAE | Dressing, Wound, Hydrogel Without Drug And/Or Biologic | Class I | 21 CFR 878.4022 | 29 | 6 |
| NAF | Antigen(Complexed),Prostate Specific,(Cpsa) | Class III | 0 | 0 | |
| NAH | System, Test, Tumor Marker, For Detection Of Bladder Cancer | Class III | 0 | 0 | |
| NAI | Lens, Prescription, Color Deficiency | Class I | 21 CFR 886.5844 | 1 | 1 |
| NAJ | Agents, Embolic, For Treatment Of Uterine Fibroids | Class II | 21 CFR 870.3300 | 8 | 1 |
| NAK | System, Test, Biotinidase | Class II | 21 CFR 862.1118 | 5 | 0 |
| NAL | Test, Immunoassay, Biosensor, Hcg | Class II | 21 CFR 862.1155 | 2 | 0 |
| NAM | Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence | Class II | 21 CFR 876.5310 | 8 | 0 |
| NAN | Tester, Acoustic, Bone Quality | Class III | 0 | 0 | |
| NAO | Test, Carbohydrate Deficient Transferrin | Class I | 21 CFR 862.1360 | 3 | 2 |
| NAP | Cardiac Support Mesh Wrap | Not classified | 0 | 0 | |
| NAQ | Lipoprotein, High Density, Hdl, Over The Counter | Class I | 21 CFR 862.1175 | 2 | 1 |
| NAS | Tympanometer | Class II | 21 CFR 874.1090 | 2 | 0 |
| NAV | Graft, Bypass, Coronary Artery | Humanitarian device exemption | 0 | 3 | |
| NAW | Microspheres Radionuclide | Class III | 0 | 5 | |
| NAY | System, Surgical, Computer Controlled Instrument | Class II | 21 CFR 876.1500 | 166 | 248 |
| NAZ | Stimulator, Bladder | Humanitarian device exemption | 0 | 0 | |
| NBC | Test, Natriuretic Peptide | Class II | 21 CFR 862.1117 | 46 | 22 |
| NBE | Sealant, Polymerizing | Class III | 0 | 11 | |
| NBF | Prosthesis, Retinal | Humanitarian device exemption | 0 | 0 | |
| NBG | Marker, Colon | Class II | 21 CFR 876.1500 | 2 | 0 |
| NBH | Accessories, Arthroscopic | Class I | 21 CFR 888.1100 | 2 | 55 |
| NBK | System, Test, (Ihc), Tumor Marker, Monitoring, Bladder Cancer | Class II | 21 CFR 864.1860 | 1 | 0 |
| NBL | Light-Induced Fluorescence Caries Detector | Class II | 21 CFR 872.1745 | 24 | 0 |
| NBN | Generator, Shock-Wave, For Pain Relief | Class III | 0 | 0 | |
| NBO | Autoantibodies, Skin (Desmoglein 1 And Desmoglein 3) | Class II | 21 CFR 866.5660 | 2 | 0 |
| NBS | Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1) | Class II | 21 CFR 866.5660 | 3 | 0 |
| NBT | Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae) | Class II | 21 CFR 866.5785 | 8 | 0 |
| NBV | Device, Engorgement, Clitoral | Class II | 21 CFR 884.5970 | 3 | 0 |
| NBW | System, Test, Blood Glucose, Over The Counter | Class II | 21 CFR 862.1345 | 510 | 137 |
| NBY | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene | Class II | 21 CFR 878.5035 | 17 | 0 |
| NBZ | Clamp And Cutter, Umbilical | Class II | 21 CFR 884.4530 | 1 | 0 |
| NCA | Clip, Implantable, For Coronary Artery Bypass Graft (Cabg) | Class II | 21 CFR 878.4300 | 3 | 0 |
| NCB | Weights, Eyelid, Implantable | Class II | 21 CFR 886.5700 | 1 | 2 |
| NCD | Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis | Class III | 0 | 3 | |
| NCE | Injector, Capsular Tension Ring | Class I | 21 CFR 886.4300 | 3 | 0 |
| NCF | Aberrometer, Ophthalmic | Class I | 21 CFR 886.1760 | 4 | 2 |
| NCG | Neuropsychiatric Interpretative Electroencephalograph Assessment Aid | Class II | 21 CFR 882.1440 | 3 | 0 |
| NCJ | Telescope, Implantable, Miniature | Class III | 0 | 0 | |
| NCK | Button, Iris, Eye, Artificial | Class I | 21 CFR 886.3200 | 1 | 0 |
| NCL | Imager, Breast, Electrical Impedance | Class III | 0 | 0 |
