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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 23 of 71
FDA product codes, page 23 of 71
CodeDevice nameClassRegulationClearancesRecalls
HRNUnit, Cryophthalmic, Ac-PoweredClass II21 CFR 886.4170100
HROUnit, Electrolysis, Ac-Powered, OphthalmicClass II21 CFR 886.425000
HRPPen, Marking, SurgicalClass I21 CFR 886.457000
HRQHemostatClass I21 CFR 878.4800153
HRRScissors, Orthopedic, SurgicalClass I21 CFR 888.454081
HRSPlate, Fixation, BoneClass II21 CFR 888.30301,327286
HRTStripper, SurgicalClass I21 CFR 888.454000
HRWDynamometer, NonpoweredClass I21 CFR 888.1250120
HRXArthroscopeClass II21 CFR 888.1100683126
HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/PolymerClass II21 CFR 888.35309168
HRZProsthesis, Knee, Hinged (Metal-Metal)Class III21 CFR 888.348000
HSAProsthesis, Knee, Hemi-, FemoralClass III21 CFR 888.357000
HSBRod, Fixation, Intramedullary And AccessoriesClass II21 CFR 888.3020531690
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic UncementedClass II21 CFR 888.36907119
HSHProsthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)Class II21 CFR 888.359050
HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/PolymerClass II21 CFR 888.31106847
HSOSawClass I21 CFR 878.480000
HSPSplint, TractionClass I21 CFR 888.589011
HSQBelt, Pelvic, TractionClass I21 CFR 888.589010
HSRUnit, Traction, Hip, Non-Powered, Non-PenetratingClass I21 CFR 888.589010
HSSHalter, Head, TractionClass I21 CFR 888.589030
HSTApparatus, Traction, Non-PoweredClass I21 CFR 888.58503811
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/PolymerClass II21 CFR 888.3520115104
HSZInstrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/AttachmentClass I21 CFR 878.4820566
HTCPliers, SurgicalClass I21 CFR 878.4800104
HTDForcepsClass I21 CFR 878.48007314
HTEElevatorClass I21 CFR 878.480003
HTFCuretteClass I21 CFR 878.480032
HTGProsthesis, Knee, Hemi-, Patellar Resurfacing, UncementedClass II21 CFR 888.358020
HTHProtractorClass I21 CFR 888.460030
HTJGauge, DepthClass I21 CFR 888.430043
HTMStimulator, Osteogenesis, Electric, Battery-Operated, InvasiveClass III00
HTNWasher, Bolt NutClass II21 CFR 888.3030934
HTOReamerClass I21 CFR 888.45401483
HTPFileClass I21 CFR 888.454050
HTQBroachClass I21 CFR 888.454005
HTRRaspClass I21 CFR 878.480092
HTSKnife, OrthopedicClass I21 CFR 888.454093
HTTBurr, OrthopedicClass I21 CFR 888.4540423
HTWBit, DrillClass I21 CFR 888.454011114
HTXRongeurClass I21 CFR 888.454057
HTYPin, Fixation, SmoothClass II21 CFR 888.304020532
HTZInstrument, Cutting, OrthopedicClass I21 CFR 878.48002127
HWAImpactorClass I21 CFR 888.4540427
HWBExtractorClass I21 CFR 888.454054
HWCScrew, Fixation, BoneClass II21 CFR 888.30401,068388
HWDStarter, Bone ScrewClass I21 CFR 888.454001
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentClass I21 CFR 878.482076101
HWFProsthesis, LigamentClass III00
HWICorkscrewClass I21 CFR 888.454010
HWJAwlClass I21 CFR 888.4540426
HWKTrephineClass I21 CFR 888.454010
HWLSet, Hollow MillClass I21 CFR 888.454000
HWMOsteotomeClass I21 CFR 878.480030
HWNInstrument, CompressionClass I21 CFR 888.454049
HWOSkid, BoneClass I21 CFR 888.454000
HWPPunch, Femoral NeckClass I21 CFR 888.454010
HWQPasserClass I21 CFR 888.454098
HWRDriver, ProsthesisClass I21 CFR 888.454046
HWTTemplateClass I21 CFR 888.48001085
HWWCountersinkClass I21 CFR 888.4540017
HWXTap, BoneClass I21 CFR 888.4540215
HXAProsthesis, Tendon, PassiveClass II21 CFR 888.3025110
HXBProbeClass I21 CFR 888.4540153
HXCWrenchClass I21 CFR 888.454068
HXDClampClass I21 CFR 878.4800144
HXEForkClass I21 CFR 888.454000
HXGTampClass I21 CFR 888.454010
HXIPasser, Wire, OrthopedicClass I21 CFR 888.454038
HXJStaple DriverClass I21 CFR 888.454062
HXKHolder, Needle; OrthopedicClass I21 CFR 888.454055
HXLMalletClass I21 CFR 878.480031
HXNApplier, CerclageClass I21 CFR 888.454020
HXOPusher, SocketClass I21 CFR 888.454031
HXPInstrument, Bending Or ContouringClass I21 CFR 888.454051
HXQCrimper, PinClass I21 CFR 888.454001
HXRSpatula, OrthopedicClass I21 CFR 878.480040
HXSTwister, WireClass I21 CFR 888.454022
HXTTape, OrthopedicClass I21 CFR 878.480000
HXWBenderClass I21 CFR 888.454033
HXXScrewdriverClass I21 CFR 888.4540432
HXYBrace, DrillClass I21 CFR 888.454071
HXZCutter, WireClass I21 CFR 888.454011
HYAForceps, Wire HoldingClass I21 CFR 878.480001
HYBEosin YClass I21 CFR 864.1850103
HYCFast GreenClass I21 CFR 864.185010
HYDFast Red Salt BClass I21 CFR 864.185010
HYESolution, Fontanna SilverClass I21 CFR 864.185000
HYFGiemsa StainClass I21 CFR 864.185041
HYGGlenner'S StainClass I21 CFR 864.185010
HYHGold ChlorideClass I21 CFR 864.185000
HYIIodine, GramsClass I21 CFR 864.185060
HYJHematoxylinClass I21 CFR 864.1850141
HYKHematoxylin Harris'SClass I21 CFR 864.185070
HYLHematoxylin Mayer'SClass I21 CFR 864.185000
HYOHematoxylin Weigert'SClass I21 CFR 864.185010
HYQIron Chloride-WeigertClass I21 CFR 864.185000
HYRLeuco-Patent BlueClass I21 CFR 864.185000
HYSLight GreenClass I21 CFR 864.185010
HYTLuxol Fast BlueClass I21 CFR 864.185000