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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 11 of 71
FDA product codes, page 11 of 71
CodeDevice nameClassRegulationClearancesRecalls
EYYDrape, Urological, DisposableClass II21 CFR 878.437020
EYZSystem, Urine Drainage, Closed, For Nonindwelling Catheter, SterileClass I21 CFR 876.5250141
EZBStylet For Catheter, Gastro-UrologyClass I21 CFR 876.5130313
EZCCatheter, CoudeClass II21 CFR 876.5130711
EZDCatheter, StraightClass II21 CFR 876.51308713
EZKCatheter, Retention TypeClass II21 CFR 876.598030
EZLCatheter, Retention Type, BalloonClass II21 CFR 876.513013085
EZMDilator, Esophageal (Metal Olive) Gastro-UrologyClass II21 CFR 876.536500
EZNDilator, Catheter, UreteralClass II21 CFR 876.54705614
EZOUrethrotomeClass II21 CFR 876.477051
EZPRod, ColostomyClass II21 CFR 876.427020
EZQPouch, ColostomyClass I21 CFR 876.590065
EZRCement, Stomal Appliance, OstomyClass I21 CFR 876.590060
EZSAppliance, Colostomy, DisposableClass I21 CFR 876.590010
EZTPacemaker, BladderClass III21 CFR 876.527000
EZWStimulator, Electrical, Implantable, For IncontinenceClass III21 CFR 876.527009
EZXMesh, Surgical, MetalClass II21 CFR 878.3300121
EZYDevice, Incontinence, Mechanical/HydraulicClass III21 CFR 876.528007
EZZProsthesis, Vas DeferensClass III10
FAAReplacer, UrethralClass III10
FABReplacer, UreteralClass III00
FACValve, UreterovesicleClass III00
FADStent, UreteralClass II21 CFR 876.462012255
FAEProsthesis, PenileClass II21 CFR 876.3630323
FAFProsthesis, TesticularClass III21 CFR 876.375001
FAGProsthesis, Urethral SphincterClass III20
FAHDilator, Urethral, MechanicalClass II21 CFR 876.552040
FAJCystoscope And Accessories, Flexible/RigidClass II21 CFR 876.15009222
FAKPanendoscope (Gastroduodenoscope)Class II21 CFR 876.150020
FALPanendoscope (Urethroscope)Class II21 CFR 876.150010
FAMSigmoidoscope And Accessories, Flexible/RigidClass II21 CFR 876.1500242
FANSigmoidoscope, Rigid, ElectricalClass II21 CFR 876.150020
FAODevice, Cystometric, AirClass III00
FAPCystometric Gas (Carbon-Dioxide) On Hydraulic DeviceClass II21 CFR 876.1620856
FAQBag, Urine Collection, Leg, For External Use, SterileClass I21 CFR 876.5250187
FARUnit, ElectrosurgicalClass II21 CFR 876.430000
FASElectrode, Electrosurgical, Active, UrologicalClass II21 CFR 876.4300589
FATBougie, Esophageal, And Gastrointestinal, Gastro-UrologyClass II21 CFR 876.536582
FAXBougie, UrologicalClass I21 CFR 876.552020
FAZSystem, Cryosurgical, Liquid Nitrogen, For UrologyClass II21 CFR 878.435000
FBIRongeur, CystoscopicClass II21 CFR 876.150000
FBJCord, Electric For Transurethral Surgical InstrumentClass II21 CFR 876.430000
FBKEndoscopic Injection Needle, Gastroenterology-UrologyClass II21 CFR 876.15008942
FBMCannula And Trocar, Suprapubic, Non-DisposableClass I21 CFR 876.509090
FBNCholedochoscope And Accessories, Flexible/RigidClass II21 CFR 876.1500439
FBOCystourethroscopeClass II21 CFR 876.1500197
FBPTelescope, Rigid, EndoscopicClass II21 CFR 876.150050
FBQTrocar, Gastro-UrologyClass II21 CFR 876.5090925
FBRUrethrometerClass I21 CFR 876.552001
FBSSound, Metal, InterconnectedClass I21 CFR 876.459010
FBWFiliform And Filiform FollowerClass I21 CFR 876.552010
FBXSound, Urethral, Metal Or PlasticClass I21 CFR 876.552011
FBYCooler, Esophageal And GastricClass III00
FBZCooler, ProstaticClass III00
FCBBag, HemostaticClass II21 CFR 876.598001
FCCEndoscopic Magnetic RetrieverClass II21 CFR 876.150030
FCDBarium Enema KitClass I21 CFR 876.521020
FCEEnema KitClass I21 CFR 876.5210300
FCFInstrument, Biopsy, Mechanical, GastrointestinalClass II21 CFR 876.107560
FCGBiopsy NeedleClass II21 CFR 876.107513354
FCHTray, Biopsy, Without Biopsy InstrumentsClass I21 CFR 876.4730214
FCIPunch, BiopsyClass II21 CFR 876.107550
FCKInstrument, Biopsy, SuctionClass II21 CFR 876.1075131
FCLForceps, Biopsy, Non-ElectricClass I21 CFR 876.10753911
FCMTray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)Class II21 CFR 876.51306043
FCNUrinary Drainage Collection Kit, For Indwelling CatheterClass II21 CFR 876.5250103
FCOBox, Battery, RechargeableClass I21 CFR 876.1500200
FCPBox, Battery, PocketClass I21 CFR 876.150021
FCQLight Source, Incandescent, DiagnosticClass II21 CFR 876.150010
FCRLight Source, Photographic, FiberopticClass II21 CFR 876.150030
FCSLight, Catheter, Fiberoptic, Glass, UreteralClass II21 CFR 876.4020103
FCTHeadlight, Fiberoptic FocusingClass II21 CFR 886.433560
FCWLight Source, Fiberoptic, RoutineClass II21 CFR 876.1500315
FCXInsufflator, Automatic Carbon-Dioxide For EndoscopeClass II21 CFR 876.1500252
FCYBulb, Inflation, For EndoscopeClass I21 CFR 876.150030
FCZTube, Smoke Removal, EndoscopicClass I21 CFR 876.150000
FDAEnteroscope And AccessoriesClass II21 CFR 876.1500200
FDBPlate, PatientClass II21 CFR 876.430000
FDCResectoscope, Working ElementClass II21 CFR 876.1500110
FDELaparoscopy KitClass II21 CFR 876.15004124
FDFColonoscope And Accessories, Flexible/RigidClass II21 CFR 876.150011525
FDGRetractor, FiberopticClass I21 CFR 876.453022
FDISnare, FlexibleClass II21 CFR 876.43006318
FDJSnare, Rigid Self-OpeningClass II21 CFR 876.430000
FDLWristlet, Patient ReturnClass II21 CFR 876.430000
FDPApparatus, Pneumoperitoneum, AutomaticClass II21 CFR 876.150010
FDRSphyncteroscopeClass II21 CFR 876.150000
FDSGastroscope And Accessories, Flexible/RigidClass II21 CFR 876.15007912
FDTDuodenoscope And Accessories, Flexible/RigidClass II21 CFR 876.15003538
FDWEsophagoscope, Rigid, Gastro-UrologyClass II21 CFR 876.150000
FDXEndoscopic Cytology BrushClass II21 CFR 876.1500445
FDYDevice, Measuring, For PanendoscopeClass I21 CFR 876.150000
FDZAttachment, Eyepiece, For Insertion Of Prescription LensClass I21 CFR 876.150020
FEAAttachment, Teaching, For EndoscopeClass I21 CFR 876.150020
FEBAccessories, Cleaning, For EndoscopeClass II21 CFR 876.15005740
FECObturator, For EndoscopeClass II21 CFR 876.150030
FEDEndoscopic Access Overtube, Gastroenterology-UrologyClass II21 CFR 876.150010512
FEFTube, Single Lumen, With Mercury Wt Balloon For Intestinal Intubation And / Or DecompressionClass II21 CFR 876.598010
FEGTube, Double Lumen For Intestinal Decompression And/Or IntubationClass II21 CFR 876.59801314
FEHElectrode, Flexible Suction CoagulatorClass II21 CFR 876.430030