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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 46 of 71
FDA product codes, page 46 of 71
CodeDevice nameClassRegulationClearancesRecalls
MXDRecorder, Event, Implantable Cardiac, (With Arrhythmia Detection)Class II21 CFR 870.10253410
MXFSystem, Dental, Hydrokinetic, Caries Removal & Cavity PreparationClass II21 CFR 872.412050
MXGLamp, Uvc, (For Treating Skin And Wounds)Class II21 CFR 878.463011
MXJEnzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1Class II21 CFR 866.3305200
MXKDevice, Analysis, Anterior SegmentClass II21 CFR 886.1850237
MXMCap, Cooling (Infants)Class III02
MXOLaser, System, PhacolysisClass II21 CFR 886.467000
MXPBone Particle CollectorClass I21 CFR 874.480003
MXQStent, Urethral, External Sphincter, PermanentClass III00
MXTDevice, Accessory, Cooling Plate For Tissue Embedding StationClass I21 CFR 864.301000
MXWSuture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride)Class II21 CFR 878.501020
MXYCannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl AcetalClass I21 CFR 886.435003
MXZImmunohistochemistry Assay, Antibody, Progesterone ReceptorClass II21 CFR 864.1860133
MYAImmunohistochemistry Antibody Assay, Estrogen ReceptorClass II21 CFR 864.1860123
MYBPillow, Cervical (For Mild Sleep Apnea)Class II21 CFR 872.557060
MYCOphthalmoscope, Laser, ScanningClass II21 CFR 886.1570230
MYDKeratome, Water JetClass I21 CFR 886.437010
MYESystem, Electrogastrography (Egg)Class II21 CFR 876.173590
MYFEnzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2Class II21 CFR 866.3305102
MYHSystem, Non-Coherent Light, Photodynamic TherapyClass III00
MYISystem, Test, Genotypic Detection, Resistant Markers, Staphylococcus ColoniesClass II21 CFR 866.1640100
MYJDevice, Mixing And Weighing, Semi-AutomatedClass II21 CFR 864.919500
MYKKit, Cord Blood CollectionNot classified00
MYLAssay,Enzyme Linked Immunosorbent,Parvovirus B19 IggClass III03
MYMAssay,Enzyme Linked Immunosorbent,Parvovirus B19 IgmClass III01
MYNAnalyzer, Medical ImageClass II21 CFR 892.2070403
MYPTest, Platelet AntibodyClass II00
MYRTest, Donor, Syphilis, Antigens, TreponemalClass II21 CFR 866.383000
MYSDevice, Ahf, Automated CryoprecipitationNot classified00
MYTBiosensor, Immunoassay, Cpk Or IsoenzymesClass II21 CFR 862.121531
MYUAccessory, Barium Sulfate, Methyl Methacrylate For CranioplastyClass II21 CFR 882.530060
MYWIrradiation, Blood IndicatorsNot classified00
MYXSystem, Blood Collection, Vacuum-Assisted, AutomatedClass I21 CFR 864.912500
MYYSeparator, Semi-Automated, Blood ComponentClass I00
MYZKit, Test (Donors), For Bloodborne PathogenClass II00
MZATest, Equipment, Automated Bloodborne PathogenNot classified03
MZCSystem, Detection, Bacterial, For Platelet Transfusion ProductsClass I21 CFR 866.256000
MZDSystem, In-Office Tinting, Contact LensesClass II21 CFR 886.592510
MZETest, Donor, CmvClass II00
MZFTest, Hiv DetectionClass II21 CFR 866.395601
MZGTest, Residual, Wbc In Leukoreduced BloodClass II21 CFR 864.862500
MZHTest, Quantitative, For Hla, Non-DiagnosticNot classified00
MZITest, Qualitative, For Hla, Non-DiagnosticUnclassified00
MZKSystem, Separation, Hematopoietic Stem CellClass III00
MZLKit, Test, Quality Control For EndotoxinNot classified00
MZMFibrin Sealant Preparation DeviceClass II21 CFR 880.586000
MZOAssay, Enzyme Linked Immunosorbent, Hepatitis C VirusClass II21 CFR 866.316937
MZPAssay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C VirusClass II21 CFR 866.3170411
MZQBalloon, Detachable, For Neurovascular OcclusionClass II21 CFR 882.595020
MZRTopical Approximation SystemClass I21 CFR 880.524000
MZTDevice, Heimlich Maneuver AssistClass II21 CFR 868.511510
MZUSystem, Test, Sodium, Enzymatic MethodClass II21 CFR 862.166520
MZVTest, System, Potassium, Enzymatic MethodClass II21 CFR 862.160040
MZWDental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain ReliefClass II21 CFR 872.327523
MZYGraft, Vascular, Stainless Steel TunnelerClass II21 CFR 870.345000
NAALens, Intraocular, AccommodativeClass III21 CFR 886.360001
NABGauze / Sponge,Nonresorbable For External UseClass I21 CFR 878.4014886
NACDressing, Wound, HydrophilicClass I21 CFR 878.401849
NADDressing, Wound, OcclusiveClass I21 CFR 878.402010819
NAEDressing, Wound, Hydrogel Without Drug And/Or BiologicClass I21 CFR 878.4022296
NAFAntigen(Complexed),Prostate Specific,(Cpsa)Class III00
NAHSystem, Test, Tumor Marker, For Detection Of Bladder CancerClass III00
NAILens, Prescription, Color DeficiencyClass I21 CFR 886.584411
NAJAgents, Embolic, For Treatment Of Uterine FibroidsClass II21 CFR 870.330081
NAKSystem, Test, BiotinidaseClass II21 CFR 862.111850
NALTest, Immunoassay, Biosensor, HcgClass II21 CFR 862.115520
NAMStimulator, Peripheral Nerve, Non-Implanted, For Urinary IncontinenceClass II21 CFR 876.531080
NANTester, Acoustic, Bone QualityClass III00
NAOTest, Carbohydrate Deficient TransferrinClass I21 CFR 862.136032
NAPCardiac Support Mesh WrapNot classified00
NAQLipoprotein, High Density, Hdl, Over The CounterClass I21 CFR 862.117521
NASTympanometerClass II21 CFR 874.109020
NAVGraft, Bypass, Coronary ArteryHumanitarian device exemption03
NAWMicrospheres RadionuclideClass III05
NAYSystem, Surgical, Computer Controlled InstrumentClass II21 CFR 876.1500166248
NAZStimulator, BladderHumanitarian device exemption00
NBCTest, Natriuretic PeptideClass II21 CFR 862.11174622
NBESealant, PolymerizingClass III011
NBFProsthesis, RetinalHumanitarian device exemption00
NBGMarker, ColonClass II21 CFR 876.150020
NBHAccessories, ArthroscopicClass I21 CFR 888.1100255
NBKSystem, Test, (Ihc), Tumor Marker, Monitoring, Bladder CancerClass II21 CFR 864.186010
NBLLight-Induced Fluorescence Caries DetectorClass II21 CFR 872.1745240
NBNGenerator, Shock-Wave, For Pain ReliefClass III00
NBOAutoantibodies, Skin (Desmoglein 1 And Desmoglein 3)Class II21 CFR 866.566020
NBSAutoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)Class II21 CFR 866.566030
NBTAntibodies, Saccharomyces Cerevisiae (S.Cerevisiae)Class II21 CFR 866.578580
NBVDevice, Engorgement, ClitoralClass II21 CFR 884.597030
NBWSystem, Test, Blood Glucose, Over The CounterClass II21 CFR 862.1345510137
NBYSuture, Surgical, Nonabsorbable, Expanded, PolytetraflouroethyleneClass II21 CFR 878.5035170
NBZClamp And Cutter, UmbilicalClass II21 CFR 884.453010
NCAClip, Implantable, For Coronary Artery Bypass Graft (Cabg)Class II21 CFR 878.430030
NCBWeights, Eyelid, ImplantableClass II21 CFR 886.570012
NCDTest, Immunity, Cell Mediated, Mycobacterium TuberculosisClass III03
NCEInjector, Capsular Tension RingClass I21 CFR 886.430030
NCFAberrometer, OphthalmicClass I21 CFR 886.176042
NCGNeuropsychiatric Interpretative Electroencephalograph Assessment AidClass II21 CFR 882.144030
NCJTelescope, Implantable, MiniatureClass III00
NCKButton, Iris, Eye, ArtificialClass I21 CFR 886.320010
NCLImager, Breast, Electrical ImpedanceClass III00