Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR

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 43 of 71
FDA product codes, page 43 of 71
CodeDevice nameClassRegulationClearancesRecalls
MHEImplant, Auditory BrainstemClass III00
MHIGiardia Spp.Class II21 CFR 866.3220276
MHJCryptosporidium Spp.Class II21 CFR 866.3220151
MHRTest, Anti-Tumor Cell SusceptibilityClass III00
MHWDressing, CompressionClass I21 CFR 880.507525
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Class II21 CFR 870.1025430286
MHYStimulator, Electrical, Implanted, For Parkinsonian TremorClass III046
MHZStimulator, Vestibular Acceleration, TherapeuticClass III12
MIANeedle, Spinal, Short TermClass II21 CFR 868.5150100
MIBElastomer, Silicone BlockClass II21 CFR 874.3620453
MICImplant, Muscle, PectoralisClass II21 CFR 874.362081
MIDSystem, Test, Anticardiolipin ImmunologicalClass II21 CFR 866.56609417
MIEHeart-Valve, AllograftClass III080
MIFProthrombin Fragment 1.2Class II21 CFR 864.732060
MIGStrip, Test IsoniazidUnclassified20
MIHSystem, Endovascular Graft, Aortic Aneurysm TreatmentClass III0176
MIJNeedle, Tumor LocalizationClass I21 CFR 878.480003
MIKDevice, Ultrasonic, Thermal AblationClass III00
MIPImplanted Fecal Incontinence DeviceClass III01
MIRShunt, Portosystemic, EndoprosthesisClass III00
MIUEnzyme Linked Immunosorbent Assay, T. CruziClass I21 CFR 866.387061
MIVImmunofluorescent Assay, T. CruziClass I21 CFR 866.387000
MIXSystem, Vocal Cord MedializationClass II21 CFR 874.3620171
MIYEnzyme Linked Immunosorbent Assay, Coccidioides ImmitisClass II21 CFR 866.313510
MIZEnzyme Linked Immunoabsorbent Assay, Histoplasma CapsulatumClass II21 CFR 866.332020
MJASusceptibility Test Powders, AntimycobacterialClass II21 CFR 866.164056
MJBAntigen, Cancer 549Class III00
MJCCatheter, Urological (Antimicrobial) And AccessoriesClass II21 CFR 876.51301023
MJDCulture Media, Antimycobacteria, Susceptibility TestClass II21 CFR 866.170030
MJECulture Media, Antifungal, Susceptibility TestClass II21 CFR 866.170010
MJFCheck Valve, Retrograde Flow (In-Line)Class II21 CFR 880.544010
MJGDevice, Percutaneous, BiopsyClass I21 CFR 878.480074
MJHLegionella, Spp., ElisaClass II21 CFR 866.3300103
MJISpecimen/Tissue, Identification OrientationClass I21 CFR 864.301000
MJJCpb Check Valve, Retrograde Flow, In-LineClass II21 CFR 870.4400936
MJKDna Probe, Trichomonas VaginalisClass I21 CFR 866.266016
MJLEia, Blastomyces DermatitidisClass II21 CFR 866.306020
MJMDna Probe, Gardnerella VaginalisClass I21 CFR 866.266020
MJNCatheter, Intravascular Occluding, TemporaryClass II21 CFR 870.44509021
MJOProsthesis, Intervertebral DiscClass III015
MJPLens, Intraocular, Toric OpticsClass III21 CFR 886.360004
MJSContrast Media, UltrasoundClass III00
MJTProsthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or UncementedClass III30
MJVDevice, Inflation, Middle EarUnclassified60
MJWProsthesis, Subtalar, Plug, PolymerClass II21 CFR 888.304020
MJXKit, Serological, Positive ControlClass I21 CFR 862.166071
MJYKit, Serological, Negative ControlClass I21 CFR 862.166010
MJZKit, Direct Antigen, Positive ControlClass I21 CFR 862.166030
MKAKit, Direct Antigen, Negative ControlClass I21 CFR 862.166000
MKBDevice, Germicidal, UltravioletClass II21 CFR 880.650000
MKDStimulator, Functional Walking Neuromuscular, Non-InvasiveClass III00
MKJAutomated External Defibrillators (Non-Wearable)Class III21 CFR 870.5310228336
MKNCatheter, Balloon, TranscervicalClass III00
MKOFalloposcopeClass II21 CFR 884.169040
MKQProcessor, Cervical Cytology Slide, AutomatedClass III029
MKTHepatitis Viral B Dna DetectionClass II21 CFR 866.317407
MKUEnzyme Immunoassay, Nicotine And Nicotine MetabolitesClass I21 CFR 862.322070
MKWCyclosporineClass II21 CFR 862.123595
MKYSystem, Skin ClosureClass I21 CFR 878.432060
MKZDna Probe, Nucleic Acid Amplification, ChlamydiaClass I21 CFR 866.3120193
MLADna Probe, YeastClass I21 CFR 866.266022
MLCMonitor, St SegmentClass II21 CFR 870.234020
MLDMonitor, St Segment With AlarmClass II21 CFR 870.1025142
MLEEnzyme Immunoassay, Antiparietal Cell Antibody, Antigen, ControlClass II21 CFR 866.511030
MLHStrip, Hama Igg, Elisa, In Vitro Test SystemClass II21 CFR 866.551000
MLKThin Layer Chromatography, Tricyclic Antidepressant DrugsClass II21 CFR 862.391020
MLLHemoglobin C (Abnormal Hemoglobin Variant)Class II21 CFR 864.741510
MLMEnzyme Immunoassay, TracrolimusClass II21 CFR 862.1678912
MLNElectrode, Electrocardiograph, Multi-FunctionClass II21 CFR 870.236009
MLOElectrocardiograph, Ambulatory, With Analysis AlgorithmClass II21 CFR 870.2800332
MLPKeratoprosthesis, Temporary Implant, Surgical UseClass II21 CFR 886.340050
MLQInhibitor, Peridural Fibrosis (Adhesion Barrier)Class III00
MLRSterilizer, ChemicalClass II21 CFR 880.68604746
MLSLabor And Delivery KitClass II21 CFR 884.4530646
MLTPelvic Exam KitClass II21 CFR 884.4530110
MLVTranscatheter Septal OccluderClass III015
MLWWarmer, Peritoneal DialysateClass II21 CFR 876.563060
MLYVapocoolant DeviceUnclassified257
MLZVitrectomy, Instrument CutterClass II21 CFR 886.415044
MMAOximeter, Fetal PulseClass III00
MMCDilator, Expansive Iris (Accessory)Class II21 CFR 886.415000
MMDToothbrush, Ionic, Battery-PoweredClass I21 CFR 872.686525
MMFPhotorefractorClass II21 CFR 886.112010
MMHBlood Establishment Computer Software And AccessoriesClass II21 CFR 864.916502
MMIImmunoassay Method, Troponin SubunitClass II21 CFR 862.12159556
MMKContainer, SharpsClass II21 CFR 880.55701143
MMLWeights, Eyelid, ExternalClass II21 CFR 886.5700140
MMOTray, Surgical, EntClass I21 CFR 874.442016
MMPCover, Barrier, ProtectiveClass II21 CFR 878.43701530
MMQTopographer, Corneal, Ac-PoweredClass I21 CFR 886.135050
MMSLubricant, Vaginal, PatientClass I21 CFR 880.637502
MMTResin, Root Canal Filling Containing ChloroformClass III21 CFR 872.382000
MMUAdhesive, Denture, Acacia And Karaya With Sodium Borate > 12% By WeightClass III21 CFR 872.340000
MMWSystem, Test, Tumor Marker, Monitoring, BladderClass II21 CFR 866.601091
MMXDevice, Percutaneous RetrievalClass II21 CFR 870.5150321
MMYLipoprotein, Low Density, RemovalClass III02
MMZTable, Cystometric, ElectricClass II21 CFR 876.489045
MNBDevice, Thermal Ablation, EndometrialClass III012
MNDLigator, EsophagealClass II21 CFR 876.4400155
MNEOrthosis, Moldable, Supportive, Skin ProtectiveClass I21 CFR 890.347520