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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 10 of 71
FDA product codes, page 10 of 71
CodeDevice nameClassRegulationClearancesRecalls
EMGForceps, Tooth Extractor, SurgicalClass I21 CFR 872.4565101
EMHForceps, Rongeur, SurgicalClass I21 CFR 872.456580
EMIFile, Bone, SurgicalClass I21 CFR 872.456544
EMJElevator, Surgical, DentalClass I21 CFR 872.456560
EMKCurette, Surgical, DentalClass I21 CFR 872.456510
EMLChisel, Bone, SurgicalClass I21 CFR 872.456520
EMMChisel, Osteotome, SurgicalClass I21 CFR 872.456541
EMNScaler, PeriodonticClass I21 CFR 872.456550
EMOKnife, PeriodonticClass I21 CFR 872.456501
EMPMarker, PeriodonticClass I21 CFR 872.456500
EMQHoe, PeriodonticClass I21 CFR 872.456500
EMRFile, PeriodonticClass I21 CFR 872.456510
EMSCurette, PeriodonticClass I21 CFR 872.456570
EMXBalloon, EpistaxisClass I21 CFR 874.4100474
ENWCatheter, NasopharyngealClass I21 CFR 874.417520
ENZTelescope, Laryngeal-BronchialClass II21 CFR 874.468030
EOBNasopharyngoscope (Flexible Or Rigid)Class II21 CFR 874.47601638
EOQBronchoscope (Flexible Or Rigid)Class II21 CFR 874.4680244160
EOXEsophagoscope (Flexible Or Rigid)Class II21 CFR 874.4710308
EPEBrush, Cleaning, Tracheal TubeClass I21 CFR 868.579521
EPFHearing Aid, Group And Auditory TrainerClass II21 CFR 874.3320320
EPGStimulator, TransdermalClass III00
EPNPump, Nebulizer, ManualClass I21 CFR 874.522020
EPPSplint, NasalClass I21 CFR 874.5800152
EPTMicroscope, SurgicalClass I21 CFR 878.47001814
EPWSupport, Head, Surgical, EntClass I21 CFR 878.495020
EPYSpeculum, EntClass I21 CFR 878.1800122
EQHSource, Carrier, Fiberoptic LightClass I21 CFR 874.4350491
EQJBur, Ear, Nose And ThroatClass I21 CFR 874.4140184
EQLLaryngostroboscopeClass I21 CFR 874.475082
EQNLaryngoscope, NasopharyngoscopeClass II21 CFR 874.4760222
ERAOtoscopeClass I21 CFR 874.4770561
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including HandpieceClass II21 CFR 874.42509129
ERYDrape, Surgical, EntClass II21 CFR 878.437000
ESDHearing Aid, Air-Conduction, PrescriptionClass I21 CFR 874.33001,3674
ESELarynx, Artificial (Battery-Powered)Class I21 CFR 874.3375130
ESFPolymer, Composite Synthetic Ptfe With Carbon-Fiber, EntClass II21 CFR 878.350020
ESHPolymer, Ent Synthetic-Pife, Silicon Elastomer, Polyethylene, PolyurethaneClass II21 CFR 874.362010
ESIPolymer, Natural-Absorbable Gelatin MaterialClass III20
ESWProsthesis, EsophagealClass II21 CFR 878.36106067
ESXTack, Sacculotomy (Cody Tack)Class II21 CFR 874.376010
ESZTube, Shunt, EndolymphaticClass II21 CFR 874.382040
ETAReplacement, Ossicular Prosthesis, TotalClass II21 CFR 874.3495392
ETBProsthesis, Partial Ossicular ReplacementClass II21 CFR 874.3450743
ETCMold, Middle-EarClass II21 CFR 874.343010
ETDTube, TympanostomyClass II21 CFR 874.388011614
ETFUnit, Examining/Treatment, EntClass I21 CFR 874.5300320
ETKTube, Toynbee DiagnosticClass I21 CFR 874.192510
ETMGustometer, SterileClass I21 CFR 874.150000
ETNStimulator, NerveClass II21 CFR 874.18209731
ETPStimulator, Caloric-WaterClass I21 CFR 874.180062
ETRAdaptor, Short Increment Sensitivity Index (Sisi)Class I21 CFR 874.107000
ETSGenerator, Electronic Noise (For Audiometric Testing)Class II21 CFR 874.112050
ETTCushion, Earphone (For Audiometric Testing)Class I21 CFR 874.110000
ETWCalibrator, Hearing Aid / Earphone And Analysis SystemsClass II21 CFR 874.3310460
ETYTester, Auditory ImpedanceClass II21 CFR 874.1090701
EWASet, Audiometer CalibrationClass I21 CFR 874.108020
EWCChamber, Acoustic (For Audiometric Testing)Class I21 CFR 874.106020
EWDProtector, Hearing (Insert)Unclassified140
EWEProtector, Hearing (Circumaural)Unclassified10
EWGLaser, Ent Microsurgical Carbon-DioxideClass II21 CFR 874.4500240
EWLProsthesis, Laryngeal (Taub)Class II21 CFR 874.3730404
EWOAudiometerClass II21 CFR 874.10502355
EWQSaw, Surgical, Ent (Electric Or Pneumatic)Class I21 CFR 874.442020
EWTDevice, Antichoke, SuctionClass III21 CFR 874.535000
EWWDevice, Antichoke, TongsClass III21 CFR 874.537000
EWYMediastinoscope, SurgicalClass II21 CFR 874.4720110
EXASelector, Size, OstomyClass I21 CFR 876.590010
EXBCollector, OstomyClass I21 CFR 876.59001025
EXDIrrigator, OstomyClass II21 CFR 876.5895120
EXEProtector, OstomyClass I21 CFR 876.590034
EXFBag, Bile CollectingClass II21 CFR 876.501093
EXGBag, Urine Collecting, UreterostomyClass I21 CFR 876.590001
EXHBag, Urinary, IleostomyClass I21 CFR 876.590000
EXIDevice, Paste-On For Incontinence, SterileClass I21 CFR 876.525070
EXJDevice, Incontinence, Urosheath Type, SterileClass I21 CFR 876.5250220
EXMTruss, UmbilicalClass I21 CFR 876.597000
EXNSupport, HerniaClass I21 CFR 876.597010
EXQCystometer, Electrical RecordingClass II21 CFR 876.162081
EXRUrinometer, MechanicalClass II21 CFR 876.180090
EXSUrinometer, ElectricalClass II21 CFR 876.180006
EXWPill, RadioClass II21 CFR 876.172510
EXXProbe, Rectal, Non-PoweredClass I21 CFR 876.473001
EXYUroflowmeterClass II21 CFR 876.1800162
EXZEquipment, Photographic, For Physiologic Function MonitorClass I21 CFR 876.150000
EYAStylet, UreteralClass I21 CFR 876.513000
EYBCatheter, Ureteral, Gastro-UrologyClass II21 CFR 876.5130284
EYCCatheter, Upper Urinary TractClass II21 CFR 876.513050
EYDStirrupsClass I21 CFR 876.489000
EYFProtector, Wound, PlasticClass I21 CFR 878.401450
EYHTable, Cysto, Non-ElectricalClass I21 CFR 876.489000
EYIAdaptor, Ureteral CatheterClass I21 CFR 876.513000
EYJHolder, Ureteral CatheterClass I21 CFR 876.513000
EYKConnector, Ureteral CatheterClass I21 CFR 876.513010
EYNTray, Irrigation, SterileClass II21 CFR 876.5980153
EYQGarment, Protective, For IncontinenceClass I21 CFR 876.5920560
EYRTourniquet, Gastro-UrologyClass I21 CFR 878.590020
EYSRibdamClass I21 CFR 876.456000
EYTSheath, Corrugated Rubber, For Nonindwelling Catheter, SterileClass I21 CFR 876.525040
EYXDrape, Pure Latex Sheet, With Self-Retaining Finger CotClass II21 CFR 878.437010