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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 49 of 71
FDA product codes, page 49 of 71
CodeDevice nameClassRegulationClearancesRecalls
NMHLaparoscope And Accessories, Gynecologic, ReprocessedClass II21 CFR 884.172000
NMILaparoscopic Insufflator And Accessories, ReprocessedClass I21 CFR 884.173000
NMJClip, Implantable, ReprocessedClass II21 CFR 878.430010
NMKTrocar, ReprocessedClass II21 CFR 870.139010
NMLCatheter, Biliary, ReprocessedClass II21 CFR 876.501011
NMMCatheter, Angioplasty, Peripheral, Transluminal, ReprocessedClass II21 CFR 870.125000
NMNInstrument, Clip, Forming/Cutting, ReprocessedClass I21 CFR 882.419000
NMPNeedle, Isotope, ReprocessedClass II21 CFR 892.573000
NMRNeedle, Spinal, Short Term, ReprocessedClass II21 CFR 868.515000
NMTNeedle, Catheter, ReprocessedClass I21 CFR 878.420000
NMUNeedle, Gastro-Urology, ReprocessedClass I21 CFR 878.480000
NMWNeedle, Dental, ReprocessedClass I21 CFR 872.473000
NMXNeedle And Needle Set, Gastro-Urology, ReprocessedClass II21 CFR 876.107500
NMYNeedle, Endoscopic, ReprocessedClass II21 CFR 876.150000
NNABiopsy Device, Percutaneous, ReprocessedClass I21 CFR 878.480000
NNBNeedle, Reproduction, Assisted, ReprocessedClass II21 CFR 884.610000
NNCNeedle, Aspiration And Needle, ReprocessedClass I21 CFR 878.480000
NNENeedle, Fistula, ReprocessedClass II21 CFR 876.554000
NNGSet, Dialysis, Single Needle With Uni-Directional Pump, ReprocessedClass II21 CFR 876.582000
NNHNeedle, Conduction, Anesthesia, ReprocessedClass II21 CFR 868.515000
NNIContainer, Specimen, Non-SterileClass I21 CFR 864.325004
NNJGustometer, Non-SterileClass I21 CFR 874.150000
NNKContainer, Specimen Mailer And Storage, Non-SterileClass I21 CFR 864.325000
NNLContainer, Specimen Mailer And Storage, Temperature Controlled, Non-SterileClass I21 CFR 864.325000
NNNCrimper, Wire, Ent, Non-SterileClass I21 CFR 874.354000
NNOJig, Piston Cutting, Ent, Non-SterileClass I21 CFR 874.354000
NNPDie, Wire Bending, Ent, Non-SterileClass I21 CFR 874.354000
NNQForceps, Wire Closure, Ent, Non-SterileClass I21 CFR 874.354000
NNRBlock, Cutting, Ent, Non-SterileClass I21 CFR 874.354000
NNSInstrument, Prosthesis Modification For Ossicular Replacement Surgery, Non-SterileClass I21 CFR 874.354000
NNTPunch, Gelfoam, Non-SterileClass I21 CFR 874.354000
NNUScissors, Wire Cutting, Ent, Non-SterileClass I21 CFR 874.354000
NNVVise, Ossicular Finger, Non-SterileClass I21 CFR 874.354000
NNWBag, Urine Collection, Leg, For External Use, Non-SterileClass I21 CFR 876.525002
NNXDevice, Incontinence, Urosheath Type, Non-SterileClass I21 CFR 876.525000
NNYSheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-SterileClass I21 CFR 876.525003
NNZSystem, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-SterileClass I21 CFR 876.525001
NOADevice, Paste-On For Incontinence, Non-SterileClass I21 CFR 876.525000
NOBUnit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-SterileClass I21 CFR 872.685500
NOCSplint, Extremity, Non-Inflatable, External, Non-SterileClass I21 CFR 878.391001
NODBoard, Arm (With Cover), Non-SterileClass I21 CFR 878.391000
NOETest, System, Immunoassay, Lipoprotein-Associated Phospholipase A2Class II21 CFR 866.5600812
NOFSystem, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental RestorationsClass II21 CFR 872.366151
NOGTopographer, Corneal, Battery PoweredClass I21 CFR 886.135000
NOHPhotokeratoscope, Battery PoweredClass I21 CFR 886.135000
NOIStand, Instrument, Ophthalmic, Battery PoweredClass I21 CFR 886.186000
NOJProsthesis, Breast, External, No AdhesiveClass I21 CFR 878.380000
NOKMaterial, External Aesthetic Restoration, No AdhesiveClass I21 CFR 878.380000
NOMAntigen, Galactomannan, Aspergillus Spp.Class I21 CFR 866.304042
NONForceps, Biopsy, Non-Electric, ReprocessedClass I21 CFR 876.107531
NOOClamp, Dialysis ArmClass I21 CFR 876.554000
NOPElisa, Antibody, West Nile VirusClass II21 CFR 866.3940102
NOTMicroscope, Automated, Image Analysis, Operator InterventionClass II21 CFR 864.1860132
NOUContinuous, Ventilator, Home UseClass II21 CFR 868.5895716
NOVAnchor, Suture, Bone Fixation, MetallicClass II21 CFR 888.303011
NOXFiller, Bone Void, Synthetic PeptideClass III04
NOYAgents, Embolic, For Treatment Of Benign Prostatic HyperplasiaClass II21 CFR 876.555041
NOZAssay, 1,5-Anhydroglucitol (15ag)Class II21 CFR 864.747020
NPBSystem, Monitoring, For Progress Of LaborClass II21 CFR 884.280040
NPEMaterial, Embolization, Neurovascular, Polymerizing Or PrecipitatingClass III01
NPFMonitor, Apnea, Home UseClass II21 CFR 868.237723
NPGCatheter, Infusion, SyringeClass II21 CFR 870.121010
NPHAntigen, Cartilage Oligomeric Matrix Protein (Comp)Class II21 CFR 866.577500
NPJProsthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/PolymerClass II21 CFR 888.3560129
NPKBarrier, Synthetic, IntraoralClass II21 CFR 872.3930311
NPLBarrier, Animal Source, IntraoralClass II21 CFR 872.39305711
NPMBone Grafting Material, Animal SourceClass II21 CFR 872.39304111
NPOKit, Immunochromatographic, Bacillus Anthracis Differential AntibodyClass II21 CFR 866.304510
NPPReprocessed Blood Pressure CuffClass II21 CFR 870.112010
NPQTest, Factor V Leiden Mutations, Genomic Dna PcrClass II21 CFR 864.7280614
NPRTest, Factor Ii G20210a Mutations, Genomic Dna PcrClass II21 CFR 864.728052
NPSTricuspid Valve Repair Device, Percutaneously DeliveredClass III00
NPTAortic Valve, Prosthesis, Percutaneously DeliveredClass III033
NPUProsthesis, Mitral Valve, Percutaneously DeliveredClass III00
NPVPulmonary Valve Prosthesis Percutaneously DeliveredHumanitarian device exemption02
NPWPercutaneously Delivered Prostheses And Tricuspid ValvesClass III01
NPZBone Grafting Material, Dental, With Biologic ComponentClass III21 CFR 872.393001
NQABiologic Material, DentalClass III21 CFR 872.393007
NQBConformer, Ophthalmic, Biological TissueClass II21 CFR 886.313013
NQCTest, Breath Analysis, Volatile Organic CompoundsHumanitarian device exemption00
NQDCardiac C-Reactive Protein, Antigen, Antiserum, And ControlClass II21 CFR 866.5270193
NQEMicroscope, SpecularClass II21 CFR 886.185092
NQFImmunohistochemistry Assay, Antibody, Epidermal Growth Factor ReceptorClass III21 CFR 864.186000
NQGStabilizer, Heart, Non-Compression, ReprocessedClass I21 CFR 870.450030
NQHSensor, Pressure, Aneurysm, ImplantableClass II21 CFR 870.285550
NQISystem, Immunomagnetic, Circulating Cancer Cell, EnumerationClass II21 CFR 866.6020139
NQJCatheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral UseClass II21 CFR 876.554040
NQKMaggots, MedicalUnclassified61
NQLSystem, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass SpectrometryClass II21 CFR 862.105553
NQMImmunoassay For Detection Of Amniotic Fluid Protein(S).Class I21 CFR 862.155023
NQNMicroscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent PositivityClass II21 CFR 864.1860154
NQOProsthesis, Spinous Process Spacer/PlateClass III06
NQPPosterior Metal/Polymer Spinal System, FusionClass II21 CFR 888.30702250
NQQSystem, Imaging, Optical Coherence Tomography (Oct)Class II21 CFR 892.1560463
NQRSealant, DuralClass III00
NQSBracket, Metal, Orthodontic, ReprocessedClass I21 CFR 872.541000
NQTDislodger, Stone, Flexible, Ureteral, ReprocessedClass II21 CFR 876.468000
NQUDislodger, Stone, Basket, Ureteral, Metal, ReprocessedClass II21 CFR 876.468000
NQVCatheter, Suction, Tracheobronchial, ReprocessedClass I21 CFR 876.468000
NQWOrthosis, Spine, Plate, Laminoplasty, MetalClass II21 CFR 888.3050300