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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 22 of 71
FDA product codes, page 22 of 71
CodeDevice nameClassRegulationClearancesRecalls
HNFScissors, OphthalmicClass I21 CFR 886.4350152
HNGRongeur, Lachrymal SacClass I21 CFR 886.435000
HNHRing, Ophthalmic (Flieringa)Class I21 CFR 886.435070
HNIRetractor, OphthalmicClass I21 CFR 886.435020
HNJPunch, Corneo-ScleralClass I21 CFR 886.435031
HNKProbe, TrabeculotomyClass I21 CFR 886.435000
HNLProbe, LachrymalClass I21 CFR 886.4350101
HNMNeedle, Ophthalmic SuturingClass I21 CFR 886.435022
HNNKnife, OphthalmicClass I21 CFR 886.435054155
HNOKeratome, Ac-PoweredClass I21 CFR 886.43708310
HNPIntroducer, SphereClass I21 CFR 886.435000
HNQHook, OphthalmicClass I21 CFR 886.4350104
HNRForceps, OphthalmicClass I21 CFR 886.43504416
HNSExpressorClass I21 CFR 886.435000
HNTErisophakeClass I21 CFR 886.435000
HNWDilator, LachrymalClass I21 CFR 886.435030
HNXDepressor, OrbitalClass I21 CFR 886.435020
HNYCystotomeClass I21 CFR 886.4350200
HNZCurette, OphthalmicClass I21 CFR 886.435020
HOACompressor, OrbitalClass I21 CFR 886.435000
HOBClamp, Muscle, OphthalmicClass I21 CFR 886.435030
HOCClip, Iris RetractorClass I21 CFR 886.435020
HODClamp, Eyelid, OphthalmicClass I21 CFR 886.435030
HOECaliper, OphthalmicClass I21 CFR 886.435070
HOFBurr, Corneal, ManualClass I21 CFR 886.435010
HOGBurr, Corneal, Battery-PoweredClass I21 CFR 886.407050
HOHSpectacle, Operating (Loupe), OphthalmicClass I21 CFR 886.477030
HOISpectacle, MagnifyingClass I21 CFR 886.5840110
HOJScreen, Tangent, TargetClass I21 CFR 886.181030
HOKScreen, Tangent, Projection, Ac-PoweredClass I21 CFR 886.181010
HOLScreen, Tangent, Felt (Campimeter)Class I21 CFR 886.181000
HOMScreen, Tangent, Ac-Powered (Campimeter)Class I21 CFR 886.181010
HONPerimeter, ManualClass I21 CFR 886.160500
HOOPerimeter, Ac-PoweredClass I21 CFR 886.160560
HOPCampimeter, Stereo, Battery-PoweredClass I21 CFR 886.181000
HOQGrid, AmslerClass I21 CFR 886.133080
HORSimulatan (Including Crossed Cylinder)Class I21 CFR 886.184010
HOSProjector, OphthalmicClass I21 CFR 886.168090
HOTAid, Vision Image IntensificationClass I21 CFR 886.591020
HOWDrum, OpticokineticClass I21 CFR 886.120010
HOXChart, Visual AcuityClass I21 CFR 886.1150320
HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)Class I21 CFR 886.4750551
HOZSponge, OphthalmicClass II21 CFR 886.47904710
HPAFrame, Trial, OphthalmicClass I21 CFR 886.141550
HPBClip, Lens, Trial, OphthalmicClass I21 CFR 886.141000
HPCSet, Lens, Trial, OphthalmicClass I21 CFR 886.1405130
HPDLens, BagoliniClass I21 CFR 886.137500
HPEAid, Vision, Optical, Battery-PoweredClass I21 CFR 886.591510
HPFAid, Vision, Electronic, Ac-PoweredClass I21 CFR 886.590010
HPGAid, Vision, Electronic, Battery-PoweredClass I21 CFR 886.590070
HPHDiathermy, Microwave, For Use Other Than Applying Therapeutic Deep HeatClass III21 CFR 890.527500
HPIAid, Vision, Optical, Ac-PoweredClass I21 CFR 886.591500
HPJInstrument, Visual Field, LaserClass II21 CFR 886.136050
HPKTonographClass II21 CFR 886.193000
HPLDevice, Fixation, Ac-Powered, OphthalmicClass I21 CFR 886.129070
HPMLocator, Metal, ElectronicClass II21 CFR 886.440040
HPNMagnet, PermanentClass I21 CFR 886.444550
HPOMagnet, Ac-PoweredClass II21 CFR 886.444030
HPPHeadlamp, Operating, Battery-OperatedClass I21 CFR 886.433501
HPQHeadlamp, Operating, Ac-PoweredClass II21 CFR 886.433550
HPSUnit, CryophthalmicClass II21 CFR 886.4170114
HPTPerimeter, Automatic, Ac-PoweredClass I21 CFR 886.1605411
HPWProbe And Counter, Isotope, For Phosphorus 32Class II21 CFR 886.167000
HPXLens, Contact (Polymethylmethacrylate)Unclassified740
HPYUnit, Electrolysis, Battery-Powered, OphthalmicClass I21 CFR 886.425010
HPZImplant, Eye SphereClass II21 CFR 886.3320394
HQAUnit, Cryotherapy, OphthalmicClass II21 CFR 886.417040
HQBPhotocoagulator And AccessoriesClass II21 CFR 886.46903032
HQCUnit, PhacofragmentationClass II21 CFR 886.467031674
HQDLens, Contact (Other Material) - DailyClass II21 CFR 886.59161185
HQEInstrument, Vitreous Aspiration And Cutting, Ac-PoweredClass II21 CFR 886.415014937
HQFLaser, OphthalmicClass II21 CFR 886.439018032
HQGLens, Spectacle, Non-Custom (Prescription)Class I21 CFR 886.5844564
HQHEye, Artificial, Non-CustomClass I21 CFR 886.320060
HQJImplant, Absorbable, (Scleral Buckling Methods)Class II21 CFR 886.330050
HQLIntraocular LensClass III21 CFR 886.3600575
HQMKeratoprosthesis, Permanent ImplantClass II21 CFR 886.340040
HQNConformer, OphthalmicClass II21 CFR 886.313071
HQOUnit, Cautery, Thermal, Ac-PoweredClass II21 CFR 886.4115120
HQPUnit, Cautery, Thermal, Battery-PoweredClass II21 CFR 886.4115243
HQQApparatus, Cautery, Radiofrequency, Battery-PoweredClass II21 CFR 886.410030
HQRApparatus, Cautery, Radiofrequency, Ac-PoweredClass II21 CFR 886.4100110
HQSBurr, Corneal, Ac-PoweredClass I21 CFR 886.407010
HQTShell, ScleralClass II21 CFR 886.380040
HQWClip, Tantalum, OphthalmicClass II21 CFR 886.310030
HQXImplant, Orbital, Extra-OcularClass II21 CFR 886.33401613
HQYSunglasses (Non-Prescription Including Photosensitive)Class I21 CFR 886.58506461
HQZFrame, SpectacleClass I21 CFR 886.58421981
HRBMicroscope, Operating, Non-Electric, OphthalmicClass I21 CFR 878.470000
HRCSterilizer, Soft-Lens, Thermal, Battery-PoweredClass II21 CFR 886.592810
HRDSterilizer, Soft-Lens, Thermal, Ac-PoweredClass II21 CFR 886.592810
HRECabinet, Instrument, Ac-Powered, OphthalmicClass I21 CFR 886.186000
HRFEngine, Trephine, Accessories, Battery-PoweredClass I21 CFR 886.407000
HRGEngine, Trephine, Accessories, Ac-PoweredClass I21 CFR 886.407060
HRHTrephine, Manual, OphthalmicClass I21 CFR 886.4350121
HRIPupillographClass I21 CFR 886.169000
HRJTable, Instrument, Powered, OphthalmicClass I21 CFR 886.485570
HRKTable, Instrument, Manual, OphthalmicClass I21 CFR 886.485520
HRLUnit, Beta, Radiation, OphthalmicClass II21 CFR 886.510000
HRMMicroscope, Operating & Accessories, Ac-Powered, OphthalmicClass I21 CFR 878.4700147