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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 20 of 71
FDA product codes, page 20 of 71
CodeDevice nameClassRegulationClearancesRecalls
HDOValve, Tubal OcclusionClass III21 CFR 884.538000
HDPElevator, UterineClass II21 CFR 884.453040
HDQDilator, Cervical, Fixed SizeClass I21 CFR 884.453064
HDRCap, CervicalClass II21 CFR 884.5250290
HDTDevice, Intrauterine, Contraceptive And IntroducerClass III21 CFR 884.536000
HDWDiaphragm, Contraceptive (And Accessories)Class II21 CFR 884.535043
HDXDilator, VaginalClass II21 CFR 884.390091
HDYDilator, Cervical, Hygroscopic-LaminariaClass II21 CFR 884.4260110
HDZKnife, Cervical ConeClass II21 CFR 884.453000
HEBTampon, Menstrual, UnscentedClass II21 CFR 884.547018936
HECInsufflator, VaginalClass I21 CFR 884.592000
HEDDouche Apparatus, Vaginal, TherapeuticClass I21 CFR 884.5900120
HEESet, Anesthesia, ParacervicalClass II21 CFR 884.510091
HEFBinder, BreastClass I21 CFR 880.516000
HEGSet, Anesthesia, PudendalClass II21 CFR 884.510000
HEHChamber, Decompression, AbdominalClass III21 CFR 884.522500
HEIMonitor, Heart-Valve Movement, Fetal, UltrasonicClass II21 CFR 884.266030
HEJMonitor, Hemic Sound, UltrasonicClass II21 CFR 884.266000
HEKMonitor, Heart Sound, Fetal, UltrasonicClass II21 CFR 884.266050
HELMonitor, Heart Rate, Fetal, UltrasonicClass II21 CFR 884.266070
HEMImager, Ultrasonic Obstetric-GynecologicClass II21 CFR 884.2225301
HENCaliper, Fetal Head, UltrasonicClass II21 CFR 884.222500
HEOAnalyzer, Data, ObstetricClass III21 CFR 884.205000
HEPMonitor, Blood-Flow, UltrasonicClass II21 CFR 884.266040
HEQMonitor, Pressure, Arterial, Fetal, UltrasonicClass II21 CFR 884.266000
HERPelvimeter, ExternalClass I21 CFR 884.452000
HESInsufflator, Carbon-Dioxide, Uterotubal (And Accessories)Class II21 CFR 884.1300130
HETLaparoscope, Gynecologic (And Accessories)Class II21 CFR 884.172033819
HEWCuldoscope (And Accessories)Class II21 CFR 884.1640184
HEXColposcope (And Colpomicroscope)Class II21 CFR 884.1630560
HEZEndoscope, Transcervical (Amnioscope)(And Accessories)Class II21 CFR 884.166000
HFAAmnioscope, Transabdominal (Fetoscope) (And Accessories)Humanitarian device exemption21 CFR 884.160000
HFBForceps, Biopsy, GynecologicalClass I21 CFR 884.4530221
HFCAspirator, EndocervicalClass II21 CFR 884.1050110
HFDWasher, EndometrialClass II21 CFR 884.118530
HFEBrush, EndometrialClass II21 CFR 884.110091
HFFAspirator, EndometrialClass II21 CFR 884.106050
HFGCoagulator, Laparoscopic, Unipolar (And Accessories)Class II21 CFR 884.4160110
HFHCoagulator, Hysteroscopic (And Accessories)Class II21 CFR 884.416000
HFICoagulator, Culdoscopic (And Accessories)Class II21 CFR 884.416080
HFJProsthesis, Fallopian TubeClass II21 CFR 884.365010
HFKMold, VaginalClass II21 CFR 884.390010
HFLDrain, CervicalClass II21 CFR 884.320010
HFMMonitor, Uterine Contraction, External (For Use In Clinic)Class II21 CFR 884.2720238
HFNTransducer, Pressure, IntrauterineClass II21 CFR 884.270091
HFORecorder, Pressure, IntrauterineClass II21 CFR 884.270040
HFPMonitor, Phonocardiographic, FetalClass II21 CFR 884.264000
HFSShield, NippleClass I21 CFR 880.5630121
HFWClamp, UmbilicalClass II21 CFR 884.4530361
HFXClamp, CircumcisionClass II21 CFR 884.45302714
HFYBand, Tubal OcclusionClass III21 CFR 884.538000
HFZCraniotribeClass II21 CFR 884.450000
HGACranioclastClass II21 CFR 884.450000
HGBClip, Tubal OcclusionClass III21 CFR 884.538002
HGCClamp, UterineClass I21 CFR 884.4520211
HGDApplicator, VaginalClass I21 CFR 884.452012
HGEAmniotomeClass I21 CFR 884.453060
HGFSource, Abortion Unit, VacuumClass II21 CFR 884.507040
HGGController, Abortion Unit, VacuumClass II21 CFR 884.507010
HGHCannula, Suction, UterineClass II21 CFR 884.507060
HGIElectrocautery, Gynecologic (And Accessories)Class II21 CFR 884.41205324
HGKEndoscope, Fetal Blood Sampling (And Accessories)Class II21 CFR 884.166010
HGLTransducer, Ultrasonic, ObstetricClass II21 CFR 884.2960364
HGMSystem, Monitoring, PerinatalClass II21 CFR 884.274021528
HGNStethoscope, FetalClass I21 CFR 884.290020
HGOMonitor, Electroencephalographic, Fetal (And Accessories)Class III21 CFR 884.262000
HGPElectrode, Circular (Spiral), Scalp And ApplicatorClass II21 CFR 884.2675173
HGSCatheter, Intrauterine And IntroducerClass II21 CFR 884.270021
HGWSampler, Blood, FetalClass II21 CFR 884.156040
HGXPump, Breast, PoweredClass II21 CFR 884.51602538
HGYPump, Breast, Non-PoweredClass I21 CFR 884.5150272
HGZHeater, Perineal, Direct ContactClass II21 CFR 884.539010
HHAHeater, Perineal, Radiant, Non-ContactClass II21 CFR 884.539000
HHDPad, Menstrual, UnscentedClass I21 CFR 884.54351360
HHECup, MenstrualClass II21 CFR 884.5400160
HHFRemover, Intrauterine Device, Contraceptive, Hook-TypeClass I21 CFR 884.453061
HHGDilator, Cervical, VibratoryClass III21 CFR 884.427000
HHISystem, Abortion, VacuumClass II21 CFR 884.5070242
HHJLocator, Intracorporeal Device, Ultrasonic, Obstetric-GynecologicClass II21 CFR 884.222510
HHKCurette, Suction, Endometrial (And Accessories)Class II21 CFR 884.1175423
HHLPad, Menstrual, Scented, Scented-DeodorizedClass II21 CFR 884.5425570
HHMSound, UterineClass I21 CFR 884.4530104
HHNCleidoclastClass II21 CFR 884.450000
HHOScrew, Fibroid, GynecologicalClass II21 CFR 884.453020
HHPTable, Obstetrical, Manual (And Accessories)Class II21 CFR 884.490020
HHQSystem, Abortion, Metreurynter-BalloonClass III21 CFR 884.505000
HHRLaser, Surgical, GynecologicClass II21 CFR 884.4550480
HHSTranscervical Contraceptive Tubal Occlusion DeviceClass III21 CFR 884.538000
HHTSpatula, Cervical, CytologicalClass II21 CFR 884.4530730
HHWPessary, VaginalClass II21 CFR 884.35754117
HHXHolograph, Fetal, AcousticalClass II21 CFR 884.222500
HHYProsthesis, Suture, CerclageClass III00
HIBSpeculum, Vaginal, NonmetalClass II21 CFR 884.4530726
HICSpeculum, Vaginal, Nonmetal, FiberopticClass II21 CFR 884.453050
HIFInsufflator, LaparoscopicClass II21 CFR 884.173017929
HIGInsufflator, HysteroscopicClass II21 CFR 884.1700576
HIHHysteroscope (And Accessories)Class II21 CFR 884.169017516
HIIStimulator, Vaginal, Muscle, Powered, For Therapeutic UseClass III21 CFR 884.594000
HILTampon, Menstrual, Scented, Scented-DeodorizedClass II21 CFR 884.5460840
HIMElectrocautery, Endoscopic And AccessoriesClass II21 CFR 884.410000