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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 16 of 71
FDA product codes, page 16 of 71
CodeDevice nameClassRegulationClearancesRecalls
GEEBrush, Biopsy, General & Plastic SurgeryClass I21 CFR 878.480070
GEFApplier, Staple, Surgical,Class I21 CFR 878.480040
GEGElevator, Surgical, General & Plastic SurgeryClass I21 CFR 878.4800120
GEHUnit, Cryosurgical, AccessoriesClass II21 CFR 878.4350264106
GEIElectrosurgical, Cutting & Coagulation & AccessoriesClass II21 CFR 878.44002,319644
GEJCarrier, LigatureClass I21 CFR 878.480054
GENForceps, General & Plastic SurgeryClass I21 CFR 878.480010410
GEOFile, Surgical, General & Plastic SurgeryClass I21 CFR 878.480020
GESBlade, ScalpelClass I21 CFR 878.48004813
GETMotor, Surgical Instrument, Pneumatic PoweredClass I21 CFR 878.48202354
GEXPowered Laser Surgical InstrumentClass II21 CFR 878.48102,887201
GEYMotor, Surgical Instrument, Ac-PoweredClass I21 CFR 878.48204127
GFABlade, Saw, General & Plastic Surgery, SurgicalClass I21 CFR 878.48202719
GFBHead, Surgical, HammerClass I21 CFR 878.482000
GFCDriver, Surgical, PinClass I21 CFR 878.482022
GFDDermatomeClass I21 CFR 878.48201222
GFEBrush, Dermabrasion, PoweredClass I21 CFR 878.482020
GFFBur, Surgical, General & Plastic SurgeryClass I21 CFR 878.48201613
GFGBit, SurgicalClass I21 CFR 878.4820317
GFIOsteotome, ManualClass I21 CFR 878.480060
GFJMallet, Surgical, General & Plastic SurgeryClass I21 CFR 878.480032
GFKFibrinogen Determination Standards And ControlsClass II21 CFR 864.734010
GFOActivated Partial ThromboplastinClass II21 CFR 864.79255210
GFSStandards And Controls, Hemoglobin, Normal And AbnormalClass II21 CFR 864.862510
GFTProtamine SulphateClass II21 CFR 864.752520
GFXFibrinogen StandardClass II21 CFR 864.734030
GGCControl, Plasma, AbnormalClass II21 CFR 864.5425400
GGFAcid HematinClass II21 CFR 864.750000
GGGGuaiac ReagentClass II21 CFR 864.655010
GGHIron StainsClass I21 CFR 864.185010
GGJFluid, Diluting, White-CellClass I21 CFR 864.820010
GGKProducts, Red-Cell Lysing ProductsClass I21 CFR 864.8540297
GGLControl, White-CellClass II21 CFR 864.862580
GGMControl, HemoglobinClass II21 CFR 864.8625152
GGNPlasma, Coagulation ControlClass II21 CFR 864.54259916
GGOReagent, Thromboplastin And ControlClass II21 CFR 864.792510
GGPTest, Qualitative And Quantitative Factor DeficiencyClass II21 CFR 864.729019014
GGQTest, Prothrombin ConsumptionClass II21 CFR 864.772020
GGTAssay, ErythropoietinClass II21 CFR 864.7250205
GGWTest, Time, Partial ThromboplastinClass II21 CFR 864.7925324
GGXPipette, SahliClass I21 CFR 864.616020
GGYPipette, DilutingClass I21 CFR 864.616000
GGZOxyhemoglobinClass II21 CFR 864.750020
GHAHemoglobin, Alkali ResistantClass II21 CFR 864.745500
GHCTube, Sedimentation RateClass I21 CFR 864.670011
GHDTest, Leukocyte Alkaline PhosphataseClass I21 CFR 864.766040
GHHFibrin Split ProductsClass II21 CFR 864.7320289
GHKCentrifuge, MicrosedimentationClass I21 CFR 864.535000
GHMTest, Sickle CellClass II21 CFR 864.7825185
GHOHemocytometerClass I21 CFR 864.616020
GHQStain, Fetal HemoglobinClass II21 CFR 864.745521
GHRReagent, Platelet AggregationClass II21 CFR 864.5700112
GHSAssay, CarboxyhemoglobinClass II21 CFR 864.742550
GHYHematocrit, Tube, Rack, Sealer, HolderClass II21 CFR 864.640020
GHZSolution, Gugol BlueClass I21 CFR 864.185000
GIATest, Leukocyte PeroxidaseClass I21 CFR 864.767530
GIEFibrometerClass II21 CFR 864.540020
GIFDiluent, Blood CellClass I21 CFR 864.82003813
GIGHemoglobinometerClass II21 CFR 864.750030
GIIGlutathione, Red-CellClass II21 CFR 864.737500
GILPlasma, Fibrinogen ControlClass II21 CFR 864.734080
GIMTubes, Vacuum Sample, With AnticoagulantClass II21 CFR 862.1675399
GIOTube, Collection, Capillary BloodClass I21 CFR 864.61502225
GIQHemoglobin SClass II21 CFR 864.741530
GIRReagent, Russel Viper VenomClass I21 CFR 864.8950161
GISTest, FibrinogenClass II21 CFR 864.7340130
GITReagent & Control, Partial Thromboplastin TimeClass II21 CFR 864.792540
GIZPlasma, Control, NormalClass II21 CFR 864.5425201
GJATest, Thrombin TimeClass II21 CFR 864.7875204
GJBThrombinClass II21 CFR 864.787510
GJCAssay, SulfhemoglobinClass II21 CFR 864.749000
GJETray, Blood CollectionClass II21 CFR 862.167571
GJGPipette, Quantitative, HematologyClass I21 CFR 864.616040
GJHStain, ReticulocyteClass I21 CFR 864.185011
GJJStains, Heinz BodyClass I21 CFR 864.185000
GJLRomanowsky StainsClass I21 CFR 864.185010
GJNFluid, Diluting, Red-CellClass I21 CFR 864.820000
GJPControl, PlateletClass II21 CFR 864.862540
GJRControl, Red-CellClass II21 CFR 864.862550
GJSTest, Time, ProthrombinClass II21 CFR 864.775012773
GJTPlasma, Coagulation Factor DeficientClass II21 CFR 864.7290793
GJWPipette, PasteurClass I21 CFR 864.616040
GJZCyanomethemoglobin Reagent And Standard SolutionClass II21 CFR 864.750020
GKAAbnormal Hemoglobin QuantitationClass II21 CFR 864.74152310
GKBDevice, Automated Sedimentation RateClass I21 CFR 864.580023
GKEOsmotic Fragility TestingClass I21 CFR 864.660002
GKFInstrument, Hematocrit, AutomatedClass II21 CFR 864.5600151
GKGCentrifuge, HematocritClass II21 CFR 864.6400114
GKHApparatus, Automated Blood Cell DilutingClass I21 CFR 864.5240142
GKJSpinner, Slide, AutomatedClass I21 CFR 864.585061
GKKCyanomethemoglobinClass II21 CFR 864.750070
GKLCounter, Cell, Automated (Particle Counter)Class II21 CFR 864.520013010
GKMHand-Tally, DifferentialClass I21 CFR 864.616040
GKNTimer, Clot, AutomatedClass II21 CFR 864.540030
GKPInstrument, Coagulation, AutomatedClass II21 CFR 864.54004931
GKQTest, Thromboplastin GenerationClass I21 CFR 864.790010
GKRSystem, Hemoglobin, AutomatedClass II21 CFR 864.5620398
GKTSeparator, Automated, Blood Cell, DiagnosticClass II21 CFR 864.9245101
GKWAggregometer, Platelet, ThrombokinetogramClass II21 CFR 864.667500
GKXInstrument, Automated Platelet CountingClass II21 CFR 864.520020