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 |
|---|---|---|---|---|---|
| MRZ | Accessories, Pump, Infusion | Class II | 21 CFR 880.5725 | 48 | 8 |
| MSA | Dressing, Wound And Burn, Occlusive, Heated | Class I | 21 CFR 878.4020 | 2 | 0 |
| MSB | System And Accessories, Isolated Heart, Transport And Preservation | Class II | 21 CFR 876.5880 | 14 | 2 |
| MSC | Barrier, Std, Oral Sex | Class II | 21 CFR 884.5300 | 7 | 0 |
| MSD | Catheter, Hemodialysis, Implanted | Class II | 21 CFR 876.5540 | 124 | 270 |
| MSE | Hemodialyzer, Re-Use, Low Flux | Class II | 21 CFR 876.5820 | 7 | 2 |
| MSF | Hemodialyzer, Re-Use, High Flux | Class II | 21 CFR 876.5860 | 8 | 0 |
| MSG | Ophthalmoscopes, Replacement Batteries, Hand-Held | Class II | 21 CFR 886.1570 | 2 | 0 |
| MSH | Respirator, Surgical | Class II | 21 CFR 878.4040 | 35 | 3 |
| MSI | Solution, Cleaning / Lubricating, Artificial Eye | Class III | 1 | 0 | |
| MSJ | Apolipoproteins | Class I | 21 CFR 862.1475 | 50 | 0 |
| MSK | Immunoassay For Blood Tacrolimus | Not classified | 0 | 0 | |
| MSL | System, Test, Topiramatee | Class II | 21 CFR 862.3350 | 1 | 0 |
| MSM | System, Test, Lipoprotein(A) | Class I | 21 CFR 862.1475 | 0 | 0 |
| MSQ | Test, Urea (Breath Or Blood) | Class I | 21 CFR 866.3110 | 17 | 2 |
| MSR | Tubing, Replacement, Phacofragmentation Unit | Class II | 21 CFR 886.4150 | 5 | 0 |
| MSS | Folders And Injectors, Intraocular Lens (Iol) | Class I | 21 CFR 886.4300 | 63 | 5 |
| MST | Antibodies, Gliadin | Class II | 21 CFR 866.5750 | 42 | 3 |
| MSV | System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) | Class II | 21 CFR 866.5660 | 46 | 1 |
| MSW | System, Test, Thyroglobulin | Class II | 21 CFR 866.6010 | 13 | 10 |
| MSX | System, Network And Communication, Physiological Monitors | Class II | 21 CFR 870.2300 | 120 | 21 |
| MSY | Strip, Test, Reagent, Residuals For Dialysate, Disinfectant | Class II | 21 CFR 876.5665 | 13 | 0 |
| MSZ | Strip, Test, Reagent, Residuals For Dialysate | Class II | 21 CFR 876.5665 | 0 | 0 |
| MTA | Lens, Intraocular, Phakic | Class III | 0 | 8 | |
| MTC | Indicator, Chemical, Enzymatic, Sterilization Process | Class II | 21 CFR 880.2800 | 2 | 0 |
| MTD | Catheter, Intracardiac Mapping, High-Density Array | Class II | 21 CFR 870.1220 | 34 | 9 |
| MTE | System, Pacing, Temporary, Acute, Internal Atrial Defibrillation | Class III | 0 | 0 | |
| MTF | Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer | Class III | 0 | 9 | |
| MTG | Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions | Class III | 0 | 3 | |
| MTH | Tray, Leukocyte Typing | Not classified | 0 | 0 | |
| MTI | Kit, Cell Screening, Fetal | Not classified | 0 | 0 | |
| MTJ | Wax, Bone | Unclassified | 43 | 4 | |
| MTK | Kit, Sample Collection, Hiv | Class III | 0 | 0 | |
| MTL | Monitor,Test,Hiv-1 | Class III | 0 | 1 | |
| MTN | Test, Syphilis, Treponemal | Not classified | 0 | 1 | |
| MTO | Software, Management, Microplate Assay | Not classified | 0 | 0 | |
| MTP | Antibody To Htlv-1, Elisa | Class III | 0 | 0 | |
| MTQ | Software, Blood Virus Applications | Not classified | 0 | 0 | |
| MTR | Progenitor Cell Enumeration | Class II | 0 | 0 | |
| MTS | Vials, Challenge, Endotoxin | Not classified | 0 | 0 | |
| MTV | Sharps Needle Destruction Device | Class II | 21 CFR 880.6210 | 1 | 1 |
| MTW | System, Water, Reproduction, Assisted, And Purification | Class II | 21 CFR 884.6170 | 2 | 0 |
| MTX | Microscope And Microscope Accessories, Reproduction, Assisted | Class I | 21 CFR 884.6190 | 0 | 1 |
| MTZ | Wrap, Implant, Orbital | Class II | 21 CFR 886.3320 | 2 | 0 |
| MUA | Bone Sonometer | Class II | 21 CFR 892.1180 | 9 | 2 |
| MUD | Oximeter, Tissue Saturation | Class II | 21 CFR 870.2700 | 74 | 7 |
| MUE | Full Field Digital, System, X-Ray, Mammographic | Class II | 21 CFR 892.1715 | 56 | 41 |
| MUH | System, X-Ray, Extraoral Source, Digital | Class II | 21 CFR 872.1800 | 206 | 9 |
| MUI | Media, Coupling, Ultrasound | Class II | 21 CFR 892.1570 | 34 | 6 |
| MUJ | System, Planning, Radiation Therapy Treatment | Class II | 21 CFR 892.5050 | 257 | 267 |
| MUK | Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue | Class II | 21 CFR 878.4400 | 3 | 0 |
| MUL | Generator, Electrosurgical, Coagulation, Cancer | Class II | 21 CFR 878.4400 | 0 | 0 |
| MUM | Stent, Metallic, Expandable, Duodenal | Class II | 21 CFR 878.3610 | 6 | 0 |
| MUQ | Glue, Surgical, Arteries | Class III | 0 | 5 | |
| MUR | Graft, Sclera, Reinforcement | Class III | 0 | 0 | |
| MUS | Fluidic, Phacoemulsification/Phacofragmentation | Class II | 21 CFR 886.4670 | 1 | 0 |
| MUT | Kit, Test For Nuclear Matrix (Numa) Protein (For Monitoring And Management Of Colorectal Cancer) | Class II | 21 CFR 866.6010 | 0 | 0 |
| MUU | System, Suction, Lipoplasty | Class II | 21 CFR 878.5040 | 40 | 15 |
| MUW | Lens, Contact (Orthokeratology) | Class II | 21 CFR 886.5916 | 6 | 0 |
| MUZ | Stimulator, Autonomic Nerve, Implanted (Depression) | Class III | 0 | 1 | |
| MVA | Orthosis, Cranial | Class II | 21 CFR 882.5970 | 43 | 0 |
| MVC | System, Test, Her-2/Neu, Ihc | Class III | 0 | 8 | |
| MVD | System, Test, Her-2/Neu, Nucleic Acid Or Serum | Class II | 21 CFR 864.1890 | 0 | 0 |
| MVE | Biosensor, Immunoassay, Myoglobin | Class II | 21 CFR 866.5680 | 1 | 0 |
| MVF | System, Laser, Photodynamic Therapy | Class III | 0 | 0 | |
| MVG | System, Laser, Fiber Optic, Photodynamic Therapy | Class III | 0 | 0 | |
| MVH | Device, Detection, Sulfide | Class II | 21 CFR 872.1870 | 1 | 1 |
| MVJ | Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm) | Class II | 21 CFR 866.5660 | 6 | 0 |
| MVK | Wearable Automated External Defibrillator | Class III | 0 | 5 | |
| MVL | Cord, Retraction | Unclassified | 36 | 1 | |
| MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) | Class II | 21 CFR 866.5660 | 40 | 1 |
| MVN | Lens, Contact, (Disposable) | Class II | 21 CFR 886.5925 | 26 | 17 |
| MVO | Kit, Test, Multiple, Drugs Of Abuse, Over The Counter | Unclassified | 18 | 1 | |
| MVR | Device, Anastomotic, Microvascular | Class II | 21 CFR 878.4300 | 9 | 6 |
| MVS | Kit, Typing, Hla-Dqb | Class II | 21 CFR 866.5660 | 1 | 0 |
| MVU | Reagents, Specific, Analyte | Class I | 21 CFR 864.4020 | 0 | 43 |
| MVV | Device, Acupressure | Unclassified | 13 | 1 | |
| MVW | Kit, Western Blot, Hiv-1 | Not classified | 0 | 0 | |
| MVX | Antibody, Monoclonal Blocking, Hiv-1 | Not classified | 0 | 0 | |
| MVY | Monoclonal, Hiv-1 | Not classified | 0 | 0 | |
| MVZ | System, Test, Home, Hiv-1 | Class III | 0 | 0 | |
| MWA | System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex | Class II | 21 CFR 866.3372 | 0 | 2 |
| MWB | Kit, Test, Saliva, Hiv-1&2 | Class III | 0 | 0 | |
| MWD | Electrosurgical, Radio Frequency, Refractive Correction | Class III | 0 | 0 | |
| MWG | System, Oxygen, Aqueous | Class III | 0 | 0 | |
| MWH | Pulmonic Valved Conduit | Humanitarian device exemption | 0 | 1 | |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | Class II | 21 CFR 870.2300 | 308 | 85 |
| MWJ | Electrocardiograph, Ambulatory (Without Analysis) | Class II | 21 CFR 870.2800 | 64 | 5 |
| MWL | Lens, Contact (Rigid Gas Permeable), Extended Wear | Class III | 21 CFR 886.5916 | 0 | 0 |
| MWM | Sensor, Electro-Optical (For Cervical Cancer) | Class III | 0 | 1 | |
| MWO | Reagent, Blood Bank, Quality Control | Not classified | 0 | 0 | |
| MWP | Cabinet, X-Ray System | Class II | 21 CFR 892.1680 | 27 | 0 |
| MWQ | System, Test, Total Antioxidant Status | Class III | 0 | 0 | |
| MWS | Stabilizer, Heart | Class I | 21 CFR 870.4500 | 4 | 17 |
| MWW | Accessory - Film Dosimetry System | Class II | 21 CFR 892.5050 | 0 | 0 |
| MWY | System, Microwave, Hair Removal | Class II | 21 CFR 878.4400 | 2 | 0 |
| MWZ | Expander, Breast, External | Class I | 21 CFR 890.5660 | 1 | 0 |
| MXA | System, Test, Breath Nitric Oxide | Class II | 21 CFR 862.3080 | 15 | 1 |
| MXB | Test, Vaginal, Bacterial Sialidase | Class I | 21 CFR 866.2660 | 2 | 1 |
| MXC | Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection) | Class II | 21 CFR 870.2800 | 23 | 5 |
