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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 19 of 71
FDA product codes, page 19 of 71
CodeDevice nameClassRegulationClearancesRecalls
GXBEsthesiometerClass I21 CFR 882.150070
GXCDevice, Electroconvulsive TherapyClass III21 CFR 882.594000
GXDGenerator, Lesion, RadiofrequencyClass II21 CFR 882.4400377
GXELeukotomeClass I21 CFR 882.460011
GXHDevice, Surgical, CryogenicClass II21 CFR 882.4250232
GXIProbe, Radiofrequency LesionClass II21 CFR 882.47256629
GXJPunch, SkullClass I21 CFR 882.475000
GXLScrewdriver, SkullplateClass I21 CFR 882.490002
GXMAnvil, Skull PlateClass I21 CFR 882.403000
GXNPlate, Cranioplasty, Preformed, Non-AlterableClass II21 CFR 882.53305711
GXOStrip, Craniosynostosis, PreformedClass II21 CFR 882.590020
GXPMethyl Methacrylate For CranioplastyClass II21 CFR 882.53004530
GXQDura SubstituteClass II21 CFR 882.59104323
GXRCover, Burr HoleClass II21 CFR 882.5250291
GXSMonitor, AlphaClass II21 CFR 882.161000
GXTMonitor, Lesion TemperatureClass II21 CFR 882.550000
GXWEchoencephalographClass II21 CFR 882.124070
GXXBlock, Test, Ultrasonic Scanner CalibrationClass I21 CFR 882.192530
GXYElectrode, CutaneousClass II21 CFR 882.132044020
GXZElectrode, NeedleClass II21 CFR 882.13505321
GYATester, Electrode/Lead, ElectroencephalographClass I21 CFR 882.141050
GYBMedia, ElectroconductiveClass II21 CFR 882.12756910
GYCElectrode, CorticalClass II21 CFR 882.1310326
GYDTransducer, TremorClass II21 CFR 882.1950150
GYEEncephalogram Telemetry SystemClass II21 CFR 882.1855200
GYKInstrument, Shunt System ImplantationClass I21 CFR 882.4545131
GYZStimulator, Intracerebral/Subcortical, ImplantedClass III21 CFR 882.584000
GZAImplanted Cerebellar StimulatorClass III21 CFR 882.582000
GZBStimulator, Spinal-Cord, Implanted (Pain Relief)Class II21 CFR 882.58801395
GZCStimulator, Neuromuscular, ImplantedClass III21 CFR 882.586001
GZDStimulator, Spinal-Cord, Implanted, For Bladder EvacuationClass III21 CFR 882.585000
GZEImplanted Diaphragmatic/Phrenic Nerve StimulatorClass III21 CFR 882.583000
GZFStimulator, Peripheral Nerve, Implanted (Pain Relief)Class II21 CFR 882.5870257
GZIStimulator, Neuromuscular, External FunctionalClass II21 CFR 882.5810612
GZJStimulator, Nerve, Transcutaneous, For Pain ReliefClass II21 CFR 882.58906067
GZKElectrode, NasopharyngealClass II21 CFR 882.134020
GZLElectrode, DepthClass II21 CFR 882.13305824
GZMAnalyzer, RigidityClass II21 CFR 882.102000
GZNRheoencephalographClass III21 CFR 882.182500
GZODevice, Galvanic Skin Response MeasurementClass II21 CFR 882.1540263
GZPStimulator, Mechanical, Evoked ResponseClass II21 CFR 882.188020
GZQInstrument, Dowel CuttingClass II21 CFR 882.427510
GZTRetractor, Self-Retaining, For NeurosurgeryClass II21 CFR 882.4800446
GZXInstrument, MicrosurgicalClass I21 CFR 882.4525131
HABSaw, Powered, And AccessoriesClass I21 CFR 878.4820216
HADRongeur, PoweredClass II21 CFR 882.484530
HAERongeur, ManualClass II21 CFR 882.4840372
HAMApparatus, ElectrosurgicalClass II21 CFR 878.4400313
HAOInstrument, Surgical, Non-PoweredClass I21 CFR 882.4535342
HASNeedle, Neurosurgical SutureClass I21 CFR 882.465000
HAWNeurological Stereotaxic InstrumentClass II21 CFR 882.4560425197
HAXTong, Skull For TractionClass II21 CFR 882.59602013
HBANeurosurgical PaddieClass II21 CFR 882.47002478
HBBMotor, Drill, PneumaticClass II21 CFR 882.43702718
HBCMotor, Drill, ElectricClass II21 CFR 882.43602739
HBDHandpiece (Brace), DrillClass I21 CFR 882.432500
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)Class II21 CFR 882.431065258
HBFDrills, Burrs, Trephines & Accessories (Compound, Powered)Class II21 CFR 882.4305196
HBGDrills, Burrs, Trephines & Accessories (Manual)Class II21 CFR 882.43001754
HBIIlluminator, Fiberoptic, Surgical FieldClass II21 CFR 878.4580280
HBKChair, PneumoencephalographicClass II21 CFR 892.182000
HBLHolder, Head, Neurosurgical (Skull Clamp)Class II21 CFR 882.44605014
HBMHeadrest, NeurosurgicalClass I21 CFR 882.444032
HBNChair, NeurosurgicalClass I21 CFR 882.412540
HBOClip, ScalpClass II21 CFR 882.4150113
HBPClip, Implanted MalleableClass II21 CFR 882.522500
HBQInstrument, Clip RemovalClass I21 CFR 882.420000
HBRRack, ClipClass I21 CFR 882.421510
HBSInstrument, Clip Forming/CuttingClass I21 CFR 882.419000
HBTApplier, Hemostatic ClipClass I21 CFR 878.4800414
HBWFastener, Plate, CranioplastyClass II21 CFR 882.536071
HBXInstrument, Cranioplasty Material FormingClass I21 CFR 882.450003
HBZCatheter, Intravascular OccludingClass III21 CFR 882.515000
HCACatheter, VentricularClass II21 CFR 882.4100106
HCBDevice, Aversive ConditioningClass II21 CFR 882.523560
HCCDevice, BiofeedbackClass II21 CFR 882.50501724
HCDCannula, VentricularClass I21 CFR 882.406030
HCEClamp, Carotid ArteryClass II21 CFR 882.517520
HCFInstrument, Ligature Passing And Knot TyingClass I21 CFR 878.480055
HCGDevice, Neurovascular EmbolizationClass II21 CFR 882.595018768
HCHClip, AneurysmClass II21 CFR 882.5200364
HCIApplier, Aneurysm ClipClass II21 CFR 882.4175145
HCJDevice, Skin Potential MeasurementClass II21 CFR 882.156020
HCSDevice, Temperature Measurement, Direct Contact, PoweredClass II21 CFR 882.157080
HCYCurette, UterineClass I21 CFR 884.4530111
HCZForceps, Surgical, GynecologicalClass II21 CFR 884.4530240
HDAForceps, ObstetricalClass II21 CFR 884.4400107
HDBExtractor, Vacuum, FetalClass II21 CFR 884.4340306
HDCTenaculum, UterineClass II21 CFR 884.4530208
HDDTable, Obstetrical, Ac-Powered (And Accessories)Class II21 CFR 884.490078
HDEHook, Fibroid, GynecologicalClass I21 CFR 884.452000
HDFSpeculum, Vaginal, MetalClass I21 CFR 884.4520113
HDGSpeculum, Vaginal, Metal, FiberopticClass I21 CFR 884.452020
HDHNeedle, Cerclage, GynecologicalClass I21 CFR 884.453000
HDIHook, Destructive, ObstetricalClass II21 CFR 884.450000
HDJScissors, UmbilicalClass I21 CFR 884.452010
HDKScissors, EpisiotomyClass I21 CFR 884.452000
HDLRetractor, VaginalClass I21 CFR 884.452021
HDMPacker, UterineClass I21 CFR 884.452000
HDNDilator, Cervical, ExpandableClass III21 CFR 884.425000