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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 41 of 71
FDA product codes, page 41 of 71
CodeDevice nameClassRegulationClearancesRecalls
LTOSpacer, CementClass III21 CFR 888.332000
LTQCalibrator For Alpha-Fetoprotein In Mid-Pregnancy Maternal SerumClass III00
LTSTest Reagents, Neisseria Gonorrhoeae BiochemicalClass I21 CFR 866.266010
LTTPanels, Test, Susceptibility, AntimicrobialClass II21 CFR 866.16405013
LTWSusceptibility Test Cards, AntimicrobialClass II21 CFR 866.16401639
LTXDiscs, ElutionClass II21 CFR 866.162020
LTYFluid, Cytological CollectionClass III00
LTZCondom With Nonoxynol-9Class II21 CFR 884.5310221
LWAProsthesis, Ligament, PtfeClass III00
LWBStimulator, Functional Neuromuscular, ScoliosisClass III00
LWEBone Marrow Collection/Transfusion KitClass II31
LWFDilator, NasalClass I21 CFR 874.3900200
LWGSurgical Table CushionClass I21 CFR 878.495041
LWHCounter, Sponge, SurgicalClass I21 CFR 880.2740154
LWIUltrasound, SinusClass II21 CFR 892.156040
LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, UncementedClass II21 CFR 888.33608126
LWKRazor, SurgicalClass I21 CFR 878.480046
LWLFluid, IntraocularClass III21 CFR 886.427510
LWMDevice, Electrical Dental AnesthesiaUnclassified150
LWOPulse-Generator, Single Chamber, Sensor Driven, ImplantableClass III00
LWPImplantable Pulse Generator, Pacemaker (Non-Crt)Class III0113
LWQHeart-Valve, MechanicalClass III05
LWRHeart-Valve, Non-Allograft TissueClass III07
LWSImplantable Cardioverter Defibrillator (Non-Crt)Class III0219
LWTOccluder, Balloon, Vena-CavaClass III00
LWWPulse-Generator, Single Chamber, SingleClass III00
LWXDevice. Laser Peripheral AngioplastyClass III00
LWZTissue Graft Of Less Than 6mmClass III20
LXATissue Graft Of 6mm And GreaterClass III04
LXBHearing Aid, Bone ConductionClass II21 CFR 874.3302537
LXCMonitor, Pressure, IntracompartmentalUnclassified152
LXEDoppler, Fetal, UltrasoundClass II21 CFR 884.266000
LXFDiathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep HeatClass III21 CFR 890.530000
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseClass I21 CFR 862.2050328
LXHOrthopedic Manual Surgical InstrumentClass I21 CFR 888.454058526
LXIGuide, Drill, LigamentClass I21 CFR 878.482080
LXJInteractive Rehabilitation Exercise DevicesClass II21 CFR 890.5360270
LXKScrapper, Skin SpecimenClass I21 CFR 878.480010
LXMManipulator, Plunger-Like JointUnclassified321
LXNProbe, Test, Heart-ValveClass I21 CFR 870.450020
LXPPlug, ScleralClass II21 CFR 886.4155100
LXQCup, EyeUnclassified50
LXRLaser, Microsurgical Argon, For Use In OtologyClass II21 CFR 874.449000
LXSLaser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting PupillaClass II21 CFR 886.439261
LXTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal CompositeClass II21 CFR 888.30305714
LXULaser For Wound HealingClass III00
LXVApparatus, Vestibular AnalysisUnclassified222
LXWColumn, Adsorption, Low Density, LipoproteinClass III10
LXYProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Polymer/Metal/PolymerClass III00
LXZGuard, InstrumentClass I21 CFR 878.480020
LYASplint, Intranasal SeptalClass I21 CFR 874.4780462
LYCBone Grafting Material, SyntheticClass II21 CFR 872.393023114
LYECytokeratinsClass II21 CFR 866.555020
LYFPneumocystis CariniiClass II21 CFR 866.378070
LYGMassager, Therapeutic, ManualClass I21 CFR 890.5660130
LYHArthrometerClass I21 CFR 890.161550
LYIStimulator, Subcortical, Implanted For EpilepsyClass III00
LYJStimulator, Autonomic Nerve, Implanted For EpilepsyClass III037
LYKAngioscopeClass II21 CFR 876.1500410
LYLAccessories, Solution, Ultrasonic Cleaners For LensesClass II21 CFR 886.59282214
LYNApparatus, Visual Reinforcement AudiometricClass II21 CFR 874.105030
LYPAccessories, Fixation, Spinal InterlaminalClass II21 CFR 888.305010
LYQAccessories, Fixation, Spinal Intervertebral BodyClass I21 CFR 888.454032
LYRHelicobacter PyloriClass I21 CFR 866.31109111
LYSBone MillClass I21 CFR 888.454041
LYTFixation AccessoryClass II21 CFR 888.303094
LYUAccessory, Surgical ApparelClass I21 CFR 878.4040569
LYVLabel Or Tag, SterileClass I21 CFR 878.480020
LYXMedia, Corneal StorageUnclassified210
LYYLatex Patient Examination GloveClass I21 CFR 880.62501,9546
LYZVinyl Patient Examination GloveClass I21 CFR 880.62507997
LZAPolymer Patient Examination GloveClass I21 CFR 880.62501,18010
LZBFinger CotClass I21 CFR 880.625051
LZCMedical Glove, SpecialtyClass I21 CFR 880.6250798
LZDJoint, Temporomandibular, ImplantClass III21 CFR 872.3940020
LZEIsometerClass I21 CFR 888.152010
LZFPump, Infusion, Analytical SamplingClass II21 CFR 880.572571
LZGPump, Infusion, InsulinClass II21 CFR 880.572585126
LZHPump, Infusion, EnteralClass II21 CFR 880.57253424
LZIDevice, Assistive ListeningClass II21 CFR 874.332070
LZJProsthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-ConstrainedUnclassified111
LZKImplant, MalarClass II21 CFR 878.3550404
LZLMicro-CondomClass III21 CFR 884.532000
LZMGuard, Skin GraftClass I21 CFR 878.401420
LZNCement ObturatorClass II21 CFR 878.3300378
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedClass II21 CFR 888.3353534177
LZPAid, Surgical, ViscoelasticClass III21 CFR 886.4275025
LZQTissue Adhesive For Ophthalmic UseClass III00
LZRUltrasound, CyclodestructiveClass II21 CFR 886.535000
LZSExcimer Laser SystemClass III029
LZUPlug, PunctumUnclassified494
LZVSystem, Cement Removal ExtractionClass II21 CFR 888.458070
LZWMonitor, Spine CurvatureUnclassified50
LZYProsthesis, Hip, Hemi-, Femoral, Metal BallClass II21 CFR 888.336083
MAAMonitor, Fetal Doppler UltrasoundClass II21 CFR 884.266093
MABMarker, Cardiopulmonary Bypass (Vein Marker)Class II21 CFR 870.345030
MACDecontamination KitClass I21 CFR 878.401421
MADCatheter, Percutaneous (Valvuloplasty)Class III00
MAEOccluder, Patent Ductus, ArteriosusClass III05
MAFStent, CoronaryClass III022