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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 14 of 71
FDA product codes, page 14 of 71
CodeDevice nameClassRegulationClearancesRecalls
FQKBinder, PerinealClass I21 CFR 880.516000
FQLStocking, Medical Support (For General Medical Purposes)Class I21 CFR 880.578062
FQMBandage, ElasticClass I21 CFR 880.50754230
FQOTable, Operating-Room, Ac-PoweredClass I21 CFR 878.49603573
FQPLamp, Operating-RoomClass II21 CFR 878.458050
FQZThermometer, Clinical Color ChangeClass I21 CFR 880.2900142
FRAPurifier, Air, Ultraviolet, MedicalClass II21 CFR 880.6500360
FRCIndicator, Biological Sterilization ProcessClass II21 CFR 880.280020640
FRFCleaner, Air, Medical RecirculatingClass II21 CFR 880.5045531
FRGWrap, SterilizationClass II21 CFR 880.685032350
FRIScale, Stand-On, PatientClass I21 CFR 880.270032
FRJChair, GeriatricClass I21 CFR 880.614001
FRKChair, Examination And TreatmentClass I21 CFR 880.614041
FRLFiber, Medical, AbsorbentClass I21 CFR 880.5300196
FRNPump, InfusionClass II21 CFR 880.5725849721
FRODressing, Wound, DrugUnclassified70982
FRPHolder, Infant PositionClass I21 CFR 880.5680140
FRQTube, LevineClass II21 CFR 876.598030
FRRChamber, Reverse Isolation, Patient CareClass II21 CFR 880.545010
FRTUnit, Isolation, SurgicalClass II21 CFR 878.507000
FRWScale, PatientClass I21 CFR 880.2720487
FRZDevice, Patient Transfer, PoweredClass II21 CFR 880.677552
FSALift, Patient, Non-Ac-PoweredClass I21 CFR 880.551013141
FSDBinder, AbdominalClass I21 CFR 880.516050
FSETable, Operating-Room, ManualClass I21 CFR 878.4950131
FSHTray, Surgical, NeedleClass I21 CFR 878.480087
FSMTray, Surgical, InstrumentClass I21 CFR 878.48007636
FSOMicroscope, Surgical, General & Plastic SurgeryClass I21 CFR 878.47001517
FSPLoupe, Diagnostic/SurgicalClass I21 CFR 878.480043
FSQLight, Surgical, InstrumentClass II21 CFR 878.458070
FSRLight, Headband, SurgicalClass II21 CFR 886.433540
FSSLight, Surgical, Floor StandingClass II21 CFR 878.4580200
FSTLight, Surgical, FiberopticClass II21 CFR 878.45804512
FSWLight, Surgical, EndoscopicClass II21 CFR 878.458080
FSXLight, Surgical, ConnectorClass II21 CFR 878.458000
FSYLight, Surgical, Ceiling MountedClass II21 CFR 878.458074454
FSZLight, Surgical, CarrierClass II21 CFR 878.458000
FTALight, Surgical, AccessoriesClass II21 CFR 878.4580265
FTCLight, Ultraviolet, DermatologicalClass II21 CFR 878.463027215
FTDLamp, SurgicalClass II21 CFR 878.45802949
FTFIlluminator, Non-RemoteClass II21 CFR 878.458040
FTGIlluminator, RemoteClass II21 CFR 878.458020
FTHCamera, Still, MicrosurgicalClass I21 CFR 878.416000
FTILamp, Endoscope, IncandescentClass II21 CFR 876.150020
FTJColonoscope, General & Plastic SurgeryClass II21 CFR 876.150000
FTLMesh, Surgical, PolymericClass II21 CFR 878.330033673
FTMMesh, SurgicalClass II21 CFR 878.330016476
FTNPlastic Surgery And Accessories KitClass I21 CFR 878.3925063
FTOProsthesis, TesticleClass III21 CFR 876.375000
FTQProsthesis, Penis, Rigid RodClass II21 CFR 876.363020
FTRProsthesis, Breast, Noninflatable, Internal, Silicone Gel-FilledClass III21 CFR 878.3540014
FTSCamera, Cine, Endoscopic, With AudioClass I21 CFR 878.416020
FTTCamera, Still, SurgicalClass I21 CFR 878.416010
FTXMirror, General & Plastic SurgeryClass I21 CFR 878.480010
FTYTape, Measuring, Rulers And CalipersClass I21 CFR 878.4800235
FTZLocator, MagneticClass I21 CFR 886.444520
FWBCamera, Television, Surgical, Without AudioClass I21 CFR 878.416062
FWCCamera, Television, Surgical, With AudioClass I21 CFR 878.416030
FWDCamera, Television, Microsurgical, Without AudioClass I21 CFR 878.416050
FWECamera, Television, Microsurgical, With AudioClass I21 CFR 878.416001
FWFCamera, Television, Endoscopic, Without AudioClass I21 CFR 878.4160232
FWGCamera, Television, Endoscopic, With AudioClass I21 CFR 878.416020
FWHCamera, Cine, Surgical, Without AudioClass I21 CFR 878.416021
FWICamera, Cine, Surgical, With AudioClass I21 CFR 878.416000
FWJCamera, Cine, Microsurgical, Without AudioClass I21 CFR 878.416001
FWKCamera, Cine, Microsurgical, With AudioClass I21 CFR 878.416000
FWLCamera, Cine, Endoscopic, Without AudioClass I21 CFR 878.416020
FWMProsthesis, Breast, Inflatable, Internal, SalineClass III21 CFR 878.353009
FWNProsthesis, Larynx (Stents And Keels)Class II21 CFR 874.3620101
FWPProsthesis, Chin, InternalClass II21 CFR 878.3550665
FWWTable, Operating-Room, PneumaticClass I21 CFR 878.496060
FWXTable, Operating-Room, MechanicalClass I21 CFR 878.495031
FWYTable, Operating-Room, Non-ElectricalClass I21 CFR 878.495040
FWZOperating Room Accessories Table TrayClass I21 CFR 878.49506137
FXESpeculum, Non-IlluminatedClass I21 CFR 878.180000
FXFSpeculum, IlluminatedClass I21 CFR 878.180010
FXGSpecula AccessoriesClass I21 CFR 878.180011
FXMCamera, Still, EndoscopicClass I21 CFR 878.416015
FXNTape, Camera, SurgicalClass I21 CFR 878.416040
FXOSuit, SurgicalClass I21 CFR 878.404060
FXPCover, Shoe, Operating-RoomClass I21 CFR 878.4040360
FXQLens, Camera, SurgicalClass I21 CFR 878.416010
FXRHolder, Camera, SurgicalClass I21 CFR 878.416020
FXSFrame, Camera, SurgicalClass I21 CFR 878.416000
FXTFilm, Camera, SurgicalClass I21 CFR 878.416000
FXWShoes, Operating-RoomClass I21 CFR 878.404010
FXXMask, SurgicalClass II21 CFR 878.404060712
FXYHood, SurgicalClass II21 CFR 878.4040133
FXZHelmet, SurgicalClass I21 CFR 878.404000
FYAGown, SurgicalClass II21 CFR 878.4040298129
FYBGown, PatientClass II21 CFR 878.404060
FYCGown, Isolation, SurgicalClass II21 CFR 878.4040682
FYDApparatus, Exhaust, SurgicalClass II21 CFR 878.50707523
FYEDress, SurgicalClass I21 CFR 878.404071
FYFCap, SurgicalClass I21 CFR 878.4040320
FYHSplint, Extremity, Noninflatable, External, SterileClass I21 CFR 878.391080
FYIAppliance, Facial Fracture, ExternalClass I21 CFR 878.325040
FZCProsthesis, Arterial Graft, Bovine Carotid ArteryClass III00
FZDProsthesis, Ear, InternalClass II21 CFR 878.359030
FZEProsthesis, Nose, InternalClass II21 CFR 878.3680420