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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
FDA review panels and the number of ingested product codes in each
Review panelPanel codeProduct codes
AnesthesiologyAN262
CardiovascularCV437
Clinical ChemistryCH527
Clinical ToxicologyTX338
DentalDE352
Ear, Nose, ThroatEN269
Gastroenterology, UrologyGU614
General HospitalHO394
General, Plastic SurgerySU562
HematologyHE281
ImmunologyIM278
Medical GeneticsMG7
MicrobiologyMI554
NeurologyNE291
Obstetrics/GynecologyOB269
OphthalmicOP345
OrthopedicOR349
PathologyPA325
Physical MedicinePM210
RadiologyRA216

214 codes carry no review panel in the FDA classification file and appear only in the index below

7,094 product codes, page 45 of 71
FDA product codes, page 45 of 71
CodeDevice nameClassRegulationClearancesRecalls
MRZAccessories, Pump, InfusionClass II21 CFR 880.5725488
MSADressing, Wound And Burn, Occlusive, HeatedClass I21 CFR 878.402020
MSBSystem And Accessories, Isolated Heart, Transport And PreservationClass II21 CFR 876.5880142
MSCBarrier, Std, Oral SexClass II21 CFR 884.530070
MSDCatheter, Hemodialysis, ImplantedClass II21 CFR 876.5540124270
MSEHemodialyzer, Re-Use, Low FluxClass II21 CFR 876.582072
MSFHemodialyzer, Re-Use, High FluxClass II21 CFR 876.586080
MSGOphthalmoscopes, Replacement Batteries, Hand-HeldClass II21 CFR 886.157020
MSHRespirator, SurgicalClass II21 CFR 878.4040353
MSISolution, Cleaning / Lubricating, Artificial EyeClass III10
MSJApolipoproteinsClass I21 CFR 862.1475500
MSKImmunoassay For Blood TacrolimusNot classified00
MSLSystem, Test, TopiramateeClass II21 CFR 862.335010
MSMSystem, Test, Lipoprotein(A)Class I21 CFR 862.147500
MSQTest, Urea (Breath Or Blood)Class I21 CFR 866.3110172
MSRTubing, Replacement, Phacofragmentation UnitClass II21 CFR 886.415050
MSSFolders And Injectors, Intraocular Lens (Iol)Class I21 CFR 886.4300635
MSTAntibodies, GliadinClass II21 CFR 866.5750423
MSVSystem,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)Class II21 CFR 866.5660461
MSWSystem, Test, ThyroglobulinClass II21 CFR 866.60101310
MSXSystem, Network And Communication, Physiological MonitorsClass II21 CFR 870.230012021
MSYStrip, Test, Reagent, Residuals For Dialysate, DisinfectantClass II21 CFR 876.5665130
MSZStrip, Test, Reagent, Residuals For DialysateClass II21 CFR 876.566500
MTALens, Intraocular, PhakicClass III08
MTCIndicator, Chemical, Enzymatic, Sterilization ProcessClass II21 CFR 880.280020
MTDCatheter, Intracardiac Mapping, High-Density ArrayClass II21 CFR 870.1220349
MTESystem, Pacing, Temporary, Acute, Internal Atrial DefibrillationClass III00
MTFTotal, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate CancerClass III09
MTGTest, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign ConditionsClass III03
MTHTray, Leukocyte TypingNot classified00
MTIKit, Cell Screening, FetalNot classified00
MTJWax, BoneUnclassified434
MTKKit, Sample Collection, HivClass III00
MTLMonitor,Test,Hiv-1Class III01
MTNTest, Syphilis, TreponemalNot classified01
MTOSoftware, Management, Microplate AssayNot classified00
MTPAntibody To Htlv-1, ElisaClass III00
MTQSoftware, Blood Virus ApplicationsNot classified00
MTRProgenitor Cell EnumerationClass II00
MTSVials, Challenge, EndotoxinNot classified00
MTVSharps Needle Destruction DeviceClass II21 CFR 880.621011
MTWSystem, Water, Reproduction, Assisted, And PurificationClass II21 CFR 884.617020
MTXMicroscope And Microscope Accessories, Reproduction, AssistedClass I21 CFR 884.619001
MTZWrap, Implant, OrbitalClass II21 CFR 886.332020
MUABone SonometerClass II21 CFR 892.118092
MUDOximeter, Tissue SaturationClass II21 CFR 870.2700747
MUEFull Field Digital, System, X-Ray, MammographicClass II21 CFR 892.17155641
MUHSystem, X-Ray, Extraoral Source, DigitalClass II21 CFR 872.18002069
MUIMedia, Coupling, UltrasoundClass II21 CFR 892.1570346
MUJSystem, Planning, Radiation Therapy TreatmentClass II21 CFR 892.5050257267
MUKElectrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic TissueClass II21 CFR 878.440030
MULGenerator, Electrosurgical, Coagulation, CancerClass II21 CFR 878.440000
MUMStent, Metallic, Expandable, DuodenalClass II21 CFR 878.361060
MUQGlue, Surgical, ArteriesClass III05
MURGraft, Sclera, ReinforcementClass III00
MUSFluidic, Phacoemulsification/PhacofragmentationClass II21 CFR 886.467010
MUTKit, Test For Nuclear Matrix (Numa) Protein (For Monitoring And Management Of Colorectal Cancer)Class II21 CFR 866.601000
MUUSystem, Suction, LipoplastyClass II21 CFR 878.50404015
MUWLens, Contact (Orthokeratology)Class II21 CFR 886.591660
MUZStimulator, Autonomic Nerve, Implanted (Depression)Class III01
MVAOrthosis, CranialClass II21 CFR 882.5970430
MVCSystem, Test, Her-2/Neu, IhcClass III08
MVDSystem, Test, Her-2/Neu, Nucleic Acid Or SerumClass II21 CFR 864.189000
MVEBiosensor, Immunoassay, MyoglobinClass II21 CFR 866.568010
MVFSystem, Laser, Photodynamic TherapyClass III00
MVGSystem, Laser, Fiber Optic, Photodynamic TherapyClass III00
MVHDevice, Detection, SulfideClass II21 CFR 872.187011
MVJDevices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)Class II21 CFR 866.566060
MVKWearable Automated External DefibrillatorClass III05
MVLCord, RetractionUnclassified361
MVMAutoantibodies, Endomysial(Tissue Transglutaminase)Class II21 CFR 866.5660401
MVNLens, Contact, (Disposable)Class II21 CFR 886.59252617
MVOKit, Test, Multiple, Drugs Of Abuse, Over The CounterUnclassified181
MVRDevice, Anastomotic, MicrovascularClass II21 CFR 878.430096
MVSKit, Typing, Hla-DqbClass II21 CFR 866.566010
MVUReagents, Specific, AnalyteClass I21 CFR 864.4020043
MVVDevice, AcupressureUnclassified131
MVWKit, Western Blot, Hiv-1Not classified00
MVXAntibody, Monoclonal Blocking, Hiv-1Not classified00
MVYMonoclonal, Hiv-1Not classified00
MVZSystem, Test, Home, Hiv-1Class III00
MWASystem, Nucleic Acid Amplification, Mycobacterium Tuberculosis ComplexClass II21 CFR 866.337202
MWBKit, Test, Saliva, Hiv-1&2Class III00
MWDElectrosurgical, Radio Frequency, Refractive CorrectionClass III00
MWGSystem, Oxygen, AqueousClass III00
MWHPulmonic Valved ConduitHumanitarian device exemption01
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Class II21 CFR 870.230030885
MWJElectrocardiograph, Ambulatory (Without Analysis)Class II21 CFR 870.2800645
MWLLens, Contact (Rigid Gas Permeable), Extended WearClass III21 CFR 886.591600
MWMSensor, Electro-Optical (For Cervical Cancer)Class III01
MWOReagent, Blood Bank, Quality ControlNot classified00
MWPCabinet, X-Ray SystemClass II21 CFR 892.1680270
MWQSystem, Test, Total Antioxidant StatusClass III00
MWSStabilizer, HeartClass I21 CFR 870.4500417
MWWAccessory - Film Dosimetry SystemClass II21 CFR 892.505000
MWYSystem, Microwave, Hair RemovalClass II21 CFR 878.440020
MWZExpander, Breast, ExternalClass I21 CFR 890.566010
MXASystem, Test, Breath Nitric OxideClass II21 CFR 862.3080151
MXBTest, Vaginal, Bacterial SialidaseClass I21 CFR 866.266021
MXCRecorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)Class II21 CFR 870.2800235