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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 12 of 71
FDA product codes, page 12 of 71
CodeDevice nameClassRegulationClearancesRecalls
FEIInstrument, Special Lens, For EndoscopeClass I21 CFR 876.150022
FEJAttachment, Binocular, For EndoscopeClass I21 CFR 876.150010
FEMAccessories, Photographic, For Endoscope (Exclude Light Sources)Class I21 CFR 876.150045
FENDevice, Cystometric, HydraulicClass II21 CFR 876.1620363
FEOLithotriptor, UltrasonicClass II21 CFR 876.4480147
FEQPump, Air, Non-Manual, For EndoscopeClass II21 CFR 876.1500215
FERAnoscope And AccessoriesClass II21 CFR 876.1500271
FESRecorder, External, Pressure, Amplifier & TransducerClass II21 CFR 876.172520
FETEndoscopic Video Imaging System/Component, Gastroenterology-UrologyClass II21 CFR 876.15001018
FEWCatheter, MalecotClass II21 CFR 876.509060
FEXInstrument, Catheter, PunchClass I21 CFR 876.509020
FEZCatheter And Tube, SuprapubicClass II21 CFR 876.509012
FFATube, Drainage, SuprapubicClass II21 CFR 876.5090310
FFDEvacuator, Bladder, Manually OperatedClass I21 CFR 876.437020
FFESystem, Water Jet Catheter, RenalClass II21 CFR 876.465010
FFFCover, Biopsy ForcepsClass I21 CFR 876.107515
FFGDevice, Urine Flow Rate Measuring, Non-Electrical, DisposableClass II21 CFR 876.1800171
FFHCollector, Urine, Pediatric, For Indwelling CatheterClass II21 CFR 876.525030
FFISystem, Alarm, ElectrosurgicalClass II21 CFR 876.430010
FFKLithotriptor, Electro-HydraulicClass II21 CFR 876.44806121
FFLDislodger, Stone, Basket, Ureteral, MetalClass II21 CFR 876.46805210
FFNClamp, Non-ElectricalClass I21 CFR 876.473050
FFORetractor, Self-RetainingClass I21 CFR 876.473053
FFPDilator, RectalClass I21 CFR 876.545050
FFQSpeculum, RectalClass I21 CFR 876.473010
FFRDevice, Locking, For Intestinal ClampClass I21 CFR 876.473000
FFSImage, Illumination, Fiberoptic, For EndoscopeClass II21 CFR 876.1500262
FFTElectrode, Ph, StomachClass I21 CFR 876.14004911
FFWString And Tubes, Gastrointestinal, To Locate Internal BleedingClass II21 CFR 876.598000
FFXSystem, Gastrointestinal Motility (Electrical)Class II21 CFR 876.1725697
FFYAdaptor, Bulbs, Miscellaneous, For EndoscopeClass I21 CFR 876.150020
FFZCord, Electric, For EndoscopeClass II21 CFR 876.150031
FGAKit, NephroscopeClass II21 CFR 876.1500108
FGBUreteroscope And Accessories, Flexible/RigidClass II21 CFR 876.150011928
FGCUrethroscopeClass II21 CFR 876.150030
FGDCatheter, Retention, Barium Enema With BagClass II21 CFR 876.598060
FGEStents, Drains And Dilators For The Biliary DuctsClass II21 CFR 876.5010478450
FGFCatheter, Ureteral Disposable (X-Ray)Class II21 CFR 876.513010
FGHCatheter, Double Lumen Female UrethrographicClass II21 CFR 876.513010
FGICatheter, Urethrographic, MaleClass II21 CFR 876.513030
FGKTripsor, Stone, BladderClass II21 CFR 876.450010
FGMProbe And Director, Gastro-UrologyClass I21 CFR 876.473071
FGNRetractor, Non-Self-RetainingClass I21 CFR 876.473000
FGODislodger, Stone, FlexibleClass II21 CFR 876.4680193
FGSCarrier, Sponge, EndoscopicClass II21 CFR 876.150041
FGWClamp, ElectricalClass II21 CFR 876.430000
FGXSnare, Non-ElectricalClass I21 CFR 876.4730047
FGYCannula, InjectionClass I21 CFR 878.420027
FHAClamp, PenileClass I21 CFR 876.5160111
FHBHook, Gastro-UrologyClass I21 CFR 876.473000
FHCAdaptor To The Cord, For Transurethral Surgical InstrumentClass II21 CFR 876.430000
FHFSystem, Evacuator, FluidClass II21 CFR 876.437030
FHGBell, CircumcisionClass II21 CFR 884.453020
FHHCrusher, Spur, ColostomyClass I21 CFR 876.473000
FHIRing, LaparotomyClass I21 CFR 876.4730010
FHJShield, CircumcisionClass II21 CFR 884.453020
FHKSpreader, Bladder NeckClass I21 CFR 876.473000
FHLScoopClass I21 CFR 876.473000
FHMApparatus, Suturing, Stomach And IntestinalClass I21 CFR 878.480020
FHNLigator, HemorrhoidalClass II21 CFR 876.4400225
FHOPneumoperitoneum NeedleClass II21 CFR 876.1500150
FHPNeedle, Pneumoperitoneum, SimpleClass II21 CFR 876.150020
FHQHolder, Needle, GastroenterologicClass I21 CFR 876.473074
FHRNeedle, Gastro-UrologyClass I21 CFR 878.480010
FHSDialyzer, Single CoilClass II21 CFR 876.5820120
FHTSet, Gavage, Infant, SterileClass II21 CFR 876.598010
FHWDevice, Impotence, Mechanical/HydraulicClass III21 CFR 876.3350020
FHXJelly, Lubricating, For Transurethral Surgical InstrumentClass II21 CFR 876.150060
FHYJelly, Contact, For Transurethral Surgical InstrumentClass II21 CFR 876.430000
FHZDesiccator, TransurethralClass II21 CFR 876.430000
FIAChair, Dialysis, Unpowered, Without ScalesClass I21 CFR 876.582000
FIBProtector, Transducer, DialysisClass II21 CFR 876.5820350
FIDTubing, DialysateClass II21 CFR 876.582030
FIENeedle, FistulaClass II21 CFR 876.5540807
FIFSet, Dialysis, Single Needle With Uni-Directional PumpClass II21 CFR 876.582060
FIGClamp, Tubing, Blood, AutomaticClass II21 CFR 876.582040
FIHPump, Infusion Or Syringe, Extra-LuminalClass II21 CFR 876.582050
FIISystem, Dialysate Delivery, SealedClass II21 CFR 876.586052
FIJSystem, Dialysate Delivery, Recirculating, Single PassClass II21 CFR 876.582010
FIKSystem, Dialysate Delivery, RecirculatingClass II21 CFR 876.582001
FILSystem, Dialysate Delivery, Single PassClass II21 CFR 876.582080
FINTank, Holding, DialysisClass II21 CFR 876.5820184
FIPSubsystem, Water PurificationClass II21 CFR 876.566511715
FIQCannula, A-V ShuntClass II21 CFR 876.5540230
FIRPump, Blood, Extra-LuminalClass II21 CFR 876.582073
FISFlowmeter, DialysateClass II21 CFR 876.582000
FIWAlarm, Pillow PressureClass II21 CFR 876.582010
FIZMeter, Conductivity, Non-RemoteClass II21 CFR 876.5820130
FJAManometer, WaterClass II21 CFR 876.582000
FJBDetector, Dialysate LevelClass II21 CFR 876.582030
FJCDetector, Blood LevelClass II21 CFR 876.582010
FJDDetector, Leak, BloodClass II21 CFR 876.582040
FJFDetector, Air BubbleClass II21 CFR 876.582050
FJGDialyzer, Parallel FlowClass II21 CFR 876.5820360
FJHDialyzer, DisposableClass II21 CFR 876.583040
FJIDialyzer, Capillary, Hollow FiberClass II21 CFR 876.58201317
FJJDialyzer, Twin CoilClass II21 CFR 876.582000
FJKSet, Tubing, Blood, With And Without Anti-Regurgitation ValveClass II21 CFR 876.58207736
FJLResectoscopeClass II21 CFR 876.15002433
FJMGuard, ShuntClass II21 CFR 876.554000