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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 44 of 71
FDA product codes, page 44 of 71
CodeDevice nameClassRegulationClearancesRecalls
MNFImplant, TemporalClass II21 CFR 878.355020
MNGExternal Urethral Occluder, Urinary Incontinence-Control, FemaleClass I21 CFR 876.516070
MNHOrthosis, Spondylolisthesis Spinal FixationClass II21 CFR 888.307030915
MNIOrthosis, Spinal Pedicle FixationClass II21 CFR 888.3070303213
MNJValve, Pressure Relief, Cardiopulmonary BypassClass II21 CFR 870.440021
MNKEndoscopic Bite BlockClass I21 CFR 876.150060
MNLAccessories, Cleaning Brushes, For EndoscopeClass I21 CFR 876.1500424
MNMReader, Cervical Cytology Slide, AutomatedClass III01
MNOSystem, Laser, Transmyocardial RevascularizationClass III01
MNQStimulator, Hypoglossal Nerve, Implanted, ApneaClass III06
MNRVentilatory Effort RecorderClass II21 CFR 868.23751657
MNSVentilator, Continuous, Non-Life-SupportingClass II21 CFR 868.58954721
MNTContinuous, Minimal Ventilatory Support, Facility Use VentilatorClass II21 CFR 868.58952564
MNUStaple, AbsorbableClass II21 CFR 888.303040
MNVStrip, Dialysate Ph IndicatorClass II21 CFR 876.582061
MNWAnalyzer, Body CompositionClass II21 CFR 870.2770790
MOAAnalyzer, Diagnostic, Fiber Optic (Colon)Class III00
MOBTest System, Antineutrophil Cytoplasmic Antibodies (Anca)Class II21 CFR 866.5660751
MOCCushion, Flotation, TherapeuticClass II21 CFR 890.517020
MODAccessory To Continuous Ventilator (Respirator)Class II21 CFR 868.5895162
MOECollagen Corneal ShieldClass I21 CFR 886.4750190
MOFGuide, Wire, Catheter, NeurovasculatureClass II21 CFR 870.1330452
MOHMonitor, Heart Rate, Fetal, Non-Stress Test (Home Use)Class II21 CFR 884.273000
MOISystem, Test, Immunological, Antigen, TumorClass II21 CFR 866.60102818
MOJFluorescence Polarization Immunoassay, Diphenylhydantoin (Free)Class II21 CFR 862.335030
MOKVaginoscope And AccessoriesClass II21 CFR 884.163020
MOLCondom, SyntheticClass II21 CFR 884.5300235
MOMSystem, Hemodynamic, ImplantableClass III013
MONSystem, Hemodialysis, Remote AccessoriesClass I21 CFR 876.582000
MOPRotator, Prosthetic Heart ValveClass I21 CFR 870.393540
MOQBattery, Replacement, RechargeableClass I21 CFR 878.482036
MOSCoil, Magnetic Resonance, SpecialtyClass II21 CFR 892.100049038
MOTIrradiator, Blood To Prevent Graft Versus Host DiseaseUnclassified162
MOUIntravascular Radiation Delivery SystemClass III00
MOVCatheters, SalpingographyClass II21 CFR 884.453053
MOZAcid, Hyaluronic, IntraarticularClass III02
MPAEndoilluminatorClass II21 CFR 876.1500411
MPBCatheter, Hemodialysis, Non-ImplantedClass II21 CFR 876.55403824
MPCAtrial DefibrillatorClass III21 CFR 870.530000
MPDAuxiliary Power Supply (Ac Or Dc) For Low-Energy Dc-DefibrillatorClass II21 CFR 870.530030
MPEAuxiliary Power Supply (Acor Dc) For External Transcutaneous Cardiac PacemakerClass II21 CFR 870.555010
MPGUrinary Carbohydrate Analysis KitClass I21 CFR 862.150510
MPIGlenoid Fossa ProsthesisClass III21 CFR 872.395000
MPJInterarticular Disc Prosthesis (Interpositional Implant)Class III21 CFR 872.397000
MPKSemi-Constrained Metal/Polymer Finger Joint ProsthesisHumanitarian device exemption01
MPLMandibular Condyle ProsthesisClass III21 CFR 872.396002
MPNTissue Adhesive For The Topical Approximation Of SkinClass II21 CFR 878.4010362
MPOInfant Heel Warmer (Chemical Heat Pack)Class I21 CFR 890.5710117
MPQContainer, Specimen, Urine, Drugs Of Abuse, Over The CounterClass I21 CFR 864.326000
MPRStent, Bladder, FetalHumanitarian device exemption01
MPTContraception CalculatorClass II21 CFR 884.535010
MPUSource, Chemiluminescent LightClass II21 CFR 884.453021
MPVImplant, Hearing, Active, Middle Ear, Partially ImplantedClass III00
MPWFiller, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, OsteoinductionClass III01
MQAAnti-Ribosomal P AntibodiesClass II21 CFR 866.510040
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)Class II21 CFR 892.1680424195
MQCMouthguard, PrescriptionUnclassified712
MQENeedle, Assisted ReproductionClass II21 CFR 884.6100331
MQFCatheter, Assisted ReproductionClass II21 CFR 884.61105336
MQGAccessory, Assisted ReproductionClass II21 CFR 884.6120479
MQHMicrotools, Assisted Reproduction (Pipettes)Class II21 CFR 884.6130264
MQIMicrotool Fabrication, Assisted ReproductionClass II21 CFR 884.614000
MQJMicromanipulators And Microinjectors, Assisted ReproductionClass II21 CFR 884.6150231
MQKLabware, Assisted ReproductionClass II21 CFR 884.6160504
MQLMedia, ReproductiveClass II21 CFR 884.618026015
MQMBilirubin (Total And Unbound) In The Neonate Test SystemClass I21 CFR 862.1113176
MQNExternal Mandibular Fixator And/Or DistractorClass II21 CFR 872.4760609
MQOProsthetic Disc Nucleus DeviceNot classified00
MQPSpinal Vertebral Body Replacement DeviceClass II21 CFR 888.306027946
MQRStent, Colonic, Metallic, ExpandableClass II21 CFR 878.3610162
MQSSystem, Hemodialysis, Access Recirculation MonitoringClass II21 CFR 876.5820181
MQTPump, Drug Administration, Closed LoopClass III00
MQUOcular PegClass II21 CFR 886.332041
MQVFiller, Bone Void, Calcium CompoundClass II21 CFR 888.3045493120
MQWTransilluminator, Fiber OpticClass I21 CFR 874.435010
MQXNeedle, Acupuncture, Single UseClass II21 CFR 880.5580911
MQZProsthesis, NailUnclassified40
MRAProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or UncementedClass III023
MRBIndicator, Biological, Liquid Chemical Sterilization ProcessClass II21 CFR 880.280040
MRCProducts, Contact Lens Care, Rigid Gas PermeableClass II21 CFR 886.5918334
MRDMammary SizerUnclassified134
MRESolution, Sodium HyaluronateClass III00
MRGSystem, Test, Vitamin DClass II21 CFR 862.18254625
MRHPump, Infusion, OphthalmicClass II21 CFR 880.5725200
MRIOrthosis, Truncal/Orthosis, LimbClass I21 CFR 890.349020
MRJRing, EndocapsularClass III00
MRKSystem, Imaging, FluorescenceClass III00
MRLScale, Sponge, Surgical, Electrically-PoweredClass I21 CFR 880.274010
MRMDefibrillator, Implantable, Dual-ChamberClass III034
MRNApparatus, Nitric Oxide DeliveryClass II21 CFR 868.51653318
MROApparatus, Nitric Oxide, Backup DeliveryClass II21 CFR 868.516540
MRPAnalyzer, Nitric OxideClass II21 CFR 868.238010
MRQAnalyzer, Nitrogen DioxideClass II21 CFR 868.238500
MRRSystem, Test, Low Density, LipoproteinClass I21 CFR 862.1475319
MRSTest System, Nicotine, Cotinine, MetabolitesClass I21 CFR 862.322031
MRUImplanted Subcortical Electrical Stimulator (Motor Disorders)Humanitarian device exemption02
MRVDrink, Glucose ToleranceClass II21 CFR 862.134533
MRWSystem, Facet Screw Spinal DeviceUnclassified794
MRXSystem, Assisted Reproduction LaserClass II21 CFR 884.6200110
MRYAppliances And Accessories, Fixation, Bone, Absorbable Single/Multiple ComponentClass II21 CFR 888.304000