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 |
|---|---|---|---|---|---|
| MHE | Implant, Auditory Brainstem | Class III | 0 | 0 | |
| MHI | Giardia Spp. | Class II | 21 CFR 866.3220 | 27 | 6 |
| MHJ | Cryptosporidium Spp. | Class II | 21 CFR 866.3220 | 15 | 1 |
| MHR | Test, Anti-Tumor Cell Susceptibility | Class III | 0 | 0 | |
| MHW | Dressing, Compression | Class I | 21 CFR 880.5075 | 2 | 5 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Class II | 21 CFR 870.1025 | 430 | 286 |
| MHY | Stimulator, Electrical, Implanted, For Parkinsonian Tremor | Class III | 0 | 46 | |
| MHZ | Stimulator, Vestibular Acceleration, Therapeutic | Class III | 1 | 2 | |
| MIA | Needle, Spinal, Short Term | Class II | 21 CFR 868.5150 | 10 | 0 |
| MIB | Elastomer, Silicone Block | Class II | 21 CFR 874.3620 | 45 | 3 |
| MIC | Implant, Muscle, Pectoralis | Class II | 21 CFR 874.3620 | 8 | 1 |
| MID | System, Test, Anticardiolipin Immunological | Class II | 21 CFR 866.5660 | 94 | 17 |
| MIE | Heart-Valve, Allograft | Class III | 0 | 80 | |
| MIF | Prothrombin Fragment 1.2 | Class II | 21 CFR 864.7320 | 6 | 0 |
| MIG | Strip, Test Isoniazid | Unclassified | 2 | 0 | |
| MIH | System, Endovascular Graft, Aortic Aneurysm Treatment | Class III | 0 | 176 | |
| MIJ | Needle, Tumor Localization | Class I | 21 CFR 878.4800 | 0 | 3 |
| MIK | Device, Ultrasonic, Thermal Ablation | Class III | 0 | 0 | |
| MIP | Implanted Fecal Incontinence Device | Class III | 0 | 1 | |
| MIR | Shunt, Portosystemic, Endoprosthesis | Class III | 0 | 0 | |
| MIU | Enzyme Linked Immunosorbent Assay, T. Cruzi | Class I | 21 CFR 866.3870 | 6 | 1 |
| MIV | Immunofluorescent Assay, T. Cruzi | Class I | 21 CFR 866.3870 | 0 | 0 |
| MIX | System, Vocal Cord Medialization | Class II | 21 CFR 874.3620 | 17 | 1 |
| MIY | Enzyme Linked Immunosorbent Assay, Coccidioides Immitis | Class II | 21 CFR 866.3135 | 1 | 0 |
| MIZ | Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum | Class II | 21 CFR 866.3320 | 2 | 0 |
| MJA | Susceptibility Test Powders, Antimycobacterial | Class II | 21 CFR 866.1640 | 5 | 6 |
| MJB | Antigen, Cancer 549 | Class III | 0 | 0 | |
| MJC | Catheter, Urological (Antimicrobial) And Accessories | Class II | 21 CFR 876.5130 | 10 | 23 |
| MJD | Culture Media, Antimycobacteria, Susceptibility Test | Class II | 21 CFR 866.1700 | 3 | 0 |
| MJE | Culture Media, Antifungal, Susceptibility Test | Class II | 21 CFR 866.1700 | 1 | 0 |
| MJF | Check Valve, Retrograde Flow (In-Line) | Class II | 21 CFR 880.5440 | 1 | 0 |
| MJG | Device, Percutaneous, Biopsy | Class I | 21 CFR 878.4800 | 7 | 4 |
| MJH | Legionella, Spp., Elisa | Class II | 21 CFR 866.3300 | 10 | 3 |
| MJI | Specimen/Tissue, Identification Orientation | Class I | 21 CFR 864.3010 | 0 | 0 |
| MJJ | Cpb Check Valve, Retrograde Flow, In-Line | Class II | 21 CFR 870.4400 | 9 | 36 |
| MJK | Dna Probe, Trichomonas Vaginalis | Class I | 21 CFR 866.2660 | 1 | 6 |
| MJL | Eia, Blastomyces Dermatitidis | Class II | 21 CFR 866.3060 | 2 | 0 |
| MJM | Dna Probe, Gardnerella Vaginalis | Class I | 21 CFR 866.2660 | 2 | 0 |
| MJN | Catheter, Intravascular Occluding, Temporary | Class II | 21 CFR 870.4450 | 90 | 21 |
| MJO | Prosthesis, Intervertebral Disc | Class III | 0 | 15 | |
| MJP | Lens, Intraocular, Toric Optics | Class III | 21 CFR 886.3600 | 0 | 4 |
| MJS | Contrast Media, Ultrasound | Class III | 0 | 0 | |
| MJT | Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented | Class III | 3 | 0 | |
| MJV | Device, Inflation, Middle Ear | Unclassified | 6 | 0 | |
| MJW | Prosthesis, Subtalar, Plug, Polymer | Class II | 21 CFR 888.3040 | 2 | 0 |
| MJX | Kit, Serological, Positive Control | Class I | 21 CFR 862.1660 | 7 | 1 |
| MJY | Kit, Serological, Negative Control | Class I | 21 CFR 862.1660 | 1 | 0 |
| MJZ | Kit, Direct Antigen, Positive Control | Class I | 21 CFR 862.1660 | 3 | 0 |
| MKA | Kit, Direct Antigen, Negative Control | Class I | 21 CFR 862.1660 | 0 | 0 |
| MKB | Device, Germicidal, Ultraviolet | Class II | 21 CFR 880.6500 | 0 | 0 |
| MKD | Stimulator, Functional Walking Neuromuscular, Non-Invasive | Class III | 0 | 0 | |
| MKJ | Automated External Defibrillators (Non-Wearable) | Class III | 21 CFR 870.5310 | 228 | 336 |
| MKN | Catheter, Balloon, Transcervical | Class III | 0 | 0 | |
| MKO | Falloposcope | Class II | 21 CFR 884.1690 | 4 | 0 |
| MKQ | Processor, Cervical Cytology Slide, Automated | Class III | 0 | 29 | |
| MKT | Hepatitis Viral B Dna Detection | Class II | 21 CFR 866.3174 | 0 | 7 |
| MKU | Enzyme Immunoassay, Nicotine And Nicotine Metabolites | Class I | 21 CFR 862.3220 | 7 | 0 |
| MKW | Cyclosporine | Class II | 21 CFR 862.1235 | 9 | 5 |
| MKY | System, Skin Closure | Class I | 21 CFR 878.4320 | 6 | 0 |
| MKZ | Dna Probe, Nucleic Acid Amplification, Chlamydia | Class I | 21 CFR 866.3120 | 19 | 3 |
| MLA | Dna Probe, Yeast | Class I | 21 CFR 866.2660 | 2 | 2 |
| MLC | Monitor, St Segment | Class II | 21 CFR 870.2340 | 2 | 0 |
| MLD | Monitor, St Segment With Alarm | Class II | 21 CFR 870.1025 | 14 | 2 |
| MLE | Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control | Class II | 21 CFR 866.5110 | 3 | 0 |
| MLH | Strip, Hama Igg, Elisa, In Vitro Test System | Class II | 21 CFR 866.5510 | 0 | 0 |
| MLK | Thin Layer Chromatography, Tricyclic Antidepressant Drugs | Class II | 21 CFR 862.3910 | 2 | 0 |
| MLL | Hemoglobin C (Abnormal Hemoglobin Variant) | Class II | 21 CFR 864.7415 | 1 | 0 |
| MLM | Enzyme Immunoassay, Tracrolimus | Class II | 21 CFR 862.1678 | 9 | 12 |
| MLN | Electrode, Electrocardiograph, Multi-Function | Class II | 21 CFR 870.2360 | 0 | 9 |
| MLO | Electrocardiograph, Ambulatory, With Analysis Algorithm | Class II | 21 CFR 870.2800 | 33 | 2 |
| MLP | Keratoprosthesis, Temporary Implant, Surgical Use | Class II | 21 CFR 886.3400 | 5 | 0 |
| MLQ | Inhibitor, Peridural Fibrosis (Adhesion Barrier) | Class III | 0 | 0 | |
| MLR | Sterilizer, Chemical | Class II | 21 CFR 880.6860 | 47 | 46 |
| MLS | Labor And Delivery Kit | Class II | 21 CFR 884.4530 | 6 | 46 |
| MLT | Pelvic Exam Kit | Class II | 21 CFR 884.4530 | 1 | 10 |
| MLV | Transcatheter Septal Occluder | Class III | 0 | 15 | |
| MLW | Warmer, Peritoneal Dialysate | Class II | 21 CFR 876.5630 | 6 | 0 |
| MLY | Vapocoolant Device | Unclassified | 25 | 7 | |
| MLZ | Vitrectomy, Instrument Cutter | Class II | 21 CFR 886.4150 | 4 | 4 |
| MMA | Oximeter, Fetal Pulse | Class III | 0 | 0 | |
| MMC | Dilator, Expansive Iris (Accessory) | Class II | 21 CFR 886.4150 | 0 | 0 |
| MMD | Toothbrush, Ionic, Battery-Powered | Class I | 21 CFR 872.6865 | 2 | 5 |
| MMF | Photorefractor | Class II | 21 CFR 886.1120 | 1 | 0 |
| MMH | Blood Establishment Computer Software And Accessories | Class II | 21 CFR 864.9165 | 0 | 2 |
| MMI | Immunoassay Method, Troponin Subunit | Class II | 21 CFR 862.1215 | 95 | 56 |
| MMK | Container, Sharps | Class II | 21 CFR 880.5570 | 114 | 3 |
| MML | Weights, Eyelid, External | Class II | 21 CFR 886.5700 | 14 | 0 |
| MMO | Tray, Surgical, Ent | Class I | 21 CFR 874.4420 | 1 | 6 |
| MMP | Cover, Barrier, Protective | Class II | 21 CFR 878.4370 | 15 | 30 |
| MMQ | Topographer, Corneal, Ac-Powered | Class I | 21 CFR 886.1350 | 5 | 0 |
| MMS | Lubricant, Vaginal, Patient | Class I | 21 CFR 880.6375 | 0 | 2 |
| MMT | Resin, Root Canal Filling Containing Chloroform | Class III | 21 CFR 872.3820 | 0 | 0 |
| MMU | Adhesive, Denture, Acacia And Karaya With Sodium Borate > 12% By Weight | Class III | 21 CFR 872.3400 | 0 | 0 |
| MMW | System, Test, Tumor Marker, Monitoring, Bladder | Class II | 21 CFR 866.6010 | 9 | 1 |
| MMX | Device, Percutaneous Retrieval | Class II | 21 CFR 870.5150 | 32 | 1 |
| MMY | Lipoprotein, Low Density, Removal | Class III | 0 | 2 | |
| MMZ | Table, Cystometric, Electric | Class II | 21 CFR 876.4890 | 4 | 5 |
| MNB | Device, Thermal Ablation, Endometrial | Class III | 0 | 12 | |
| MND | Ligator, Esophageal | Class II | 21 CFR 876.4400 | 15 | 5 |
| MNE | Orthosis, Moldable, Supportive, Skin Protective | Class I | 21 CFR 890.3475 | 2 | 0 |
