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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 47 of 71
FDA product codes, page 47 of 71
CodeDevice nameClassRegulationClearancesRecalls
NCOImplant, Cartilage, For Articular Cartilage RepairClass III00
NCRApparatus, Cutting, Radiofrequency, Electrosurgical, Battery-PoweredClass II21 CFR 886.410031
NCSSystem, Imaging, Holography, AcousticClass II21 CFR 892.155030
NCTInstrument, Glucose, Noninvasive TechnologyClass III00
NCVLithotripter, Shockwave (For Treating Gallbladder Stones)Class III00
NCWSystem, Test, Her-2/Neu, MonitoringClass II21 CFR 866.601031
NCXSystem, Hypothermia, Intravenous, CoolingClass II21 CFR 870.59002635
NCZLens, Contact, For Color Vision DeficiencyClass II21 CFR 886.592510
NDAHelmet, Cranial, For Protective UseClass I21 CFR 890.302501
NDCCalculator, Drug DoseClass II21 CFR 868.18905513
NDDCerclage, Fixation, MetallicClass II21 CFR 888.301010
NDERod, Fixation, Intramedullary And Accessories, Metallic And Non-CollapsibleClass II21 CFR 888.302001
NDFPlate, Fixation, Bone, Non-Spinal, MetallicClass II21 CFR 888.303031
NDGWasher, Bolt, Nut, Non-Spinal, MetallicClass II21 CFR 888.303011
NDHNail, Fixation, Bone, MetallicClass II21 CFR 888.303003
NDIStaple, Fixation, Bone, MetallicClass II21 CFR 888.303000
NDJScrew, Fixation, Bone, Non-Spinal, MetallicClass II21 CFR 888.3040013
NDKSystem, External Fixator (With Metallic Invasive Components)Class II21 CFR 888.304030
NDLPin, Fixation, Smooth, MetallicClass II21 CFR 888.304021
NDMPin, Fixation, Threaded, MetallicClass II21 CFR 888.304010
NDNCement, Bone, VertebroplastyClass II21 CFR 888.302710886
NDPAccessories, Implant, Dental, EndosseousClass I21 CFR 872.3980457
NDQSystem, Catheter Or Guidewire, Steerable (Magnetic)Class II21 CFR 870.129020
NDREnzyme Immunoassay, Inhibin-AClass I21 CFR 862.126013
NDSMedia, Culture, Ex Vivo, Tissue And CellClass II21 CFR 876.588597
NDVTest, Ecarin Clotting Time (Ect)Humanitarian device exemption00
NDWAssay, Porphyrin, Spectrophotometry, LithiumClass II21 CFR 862.356077
NDYTest, Cystatin CClass II21 CFR 862.1225224
NDZAssay, Nucleic Acid Amplification, Growth Identification, Mycobacterium TuberculosisClass I21 CFR 866.337011
NEACement, Ear, Nose And ThroatClass II21 CFR 872.327560
NECBandage, Liquid, Skin ProtectantClass I21 CFR 880.509036
NEGFinger Semi-Constrained Pyrolytic Carbon Uncemented ProsthesisClass III02
NEHAnchor, FascialClass II21 CFR 878.430010
NEIProsthesis, Condyle, Mandibular, TemporaryClass II21 CFR 872.477070
NEJSystem, Cryosurgical, Liquid Nitrogen, For GastroenterologyClass II21 CFR 878.435000
NEKFiller, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, OsteoinductionClass III08
NEOSystem, Test, OsteocalcinClass II21 CFR 862.105022
NEPSystem/Device, Pharmacy CompoundingClass II21 CFR 880.5440041
NEQDevice, Telemedicine, RoboticClass II21 CFR 876.150020
NEUMarker, Radiographic, ImplantableClass II21 CFR 878.430011014
NEWSuture, Surgical, Absorbable, PolydioxanoneClass II21 CFR 878.48406740
NEYSystem, Ablation, Microwave And AccessoriesClass II21 CFR 878.44006827
NEZSystem, Imaging, Gastrointestinal, Wireless, CapsuleClass II21 CFR 876.1300476
NFATemporary Coronary Saphenous Vein Bypass Graft For Embolic ProtectionClass II21 CFR 870.1250224
NFBConserver, OxygenClass II21 CFR 868.5905716
NFDSelector, Color, Spectacle, Lens, TintClass I21 CFR 886.116010
NFEMaterials, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Alveolar Ridge AugmentationClass II21 CFR 872.368000
NFFDevice, Storage, Images, OphthalmicClass I21 CFR 892.201011
NFGDevice, Communications, Images, OphthalmicClass I21 CFR 892.202001
NFHDigitizer, Images, OphthalmicClass II21 CFR 892.203000
NFIDevice, Hardcopy, Images, OphthalmicClass II21 CFR 892.204000
NFJSystem, Image Management, OphthalmicClass II21 CFR 892.20505314
NFKKit, Repair, Catheter, HemodialysisClass II21 CFR 876.55401112
NFMExpander, Tissue, OrbitalClass II21 CFR 886.332020
NFOStimulator, Transcutaneous Electrical, Aesthetic PurposesClass II21 CFR 882.5890822
NFPDevice, Dental Sonography, For Diagnosis Of Tmj / Mpd DisordersClass II21 CFR 872.205000
NFQDevice, Dental Sonography, For Monitoring Jaw SoundsClass I21 CFR 872.205040
NFRDevice, Jaw Tracking, For Diagnosis Of Tmj / Mpd DisordersClass II21 CFR 872.206000
NFSDevice, Jaw Tracking, For Monitoring Jaw PositionsClass I21 CFR 872.206020
NFTTest, Amphetamine, Over The CounterClass II21 CFR 862.3100320
NFVTest, Benzodiazepine, Over The CounterClass II21 CFR 862.317000
NFWTest, Cannabinoid, Over The CounterClass II21 CFR 862.387040
NFXTest, Cholesterol, Total, Over The CounterClass I21 CFR 862.117510
NFYTest, Cocaine And Cocaine Metabolites, Over The CounterClass II21 CFR 862.325000
NFZTest, Creatinine, Over The CounterClass II21 CFR 862.122500
NGATest, Follicle Stimulating Hormone (Fsh), Over The CounterClass I21 CFR 862.130022
NGBTest, Glycosylated Hemoglobin, Over The CounterClass II21 CFR 864.747000
NGDTest, Lactic Acid, Over The CounterClass I21 CFR 862.145000
NGETest, Luteinizing Hormone (Lh), Over The CounterClass I21 CFR 862.1485610
NGGTest, Methamphetamine, Over The CounterClass II21 CFR 862.361011
NGITest, Morphine, Over The CounterClass II21 CFR 862.364000
NGJTest, Nitrite, Urinary, Non-Quantitative, Over The CounterClass I21 CFR 862.151011
NGKTest, Occult Blood, Over The CounterClass II21 CFR 864.655000
NGLTest, Opiates, Over The CounterClass II21 CFR 862.3650230
NGMTest, Phencyclidine (Pcp), Over The CounterUnclassified00
NGOTest, Triglycerides, Over The CounterClass I21 CFR 862.170500
NGRTester, Stiffness, Cartilage, ArthroscopicClass II21 CFR 888.110020
NGSAssay, Endotoxin Activity, ChemiluminescentClass II21 CFR 866.321020
NGTSaline, Vascular Access FlushClass II21 CFR 880.52004061
NGUBalloon, Liver TamponadeClass II21 CFR 876.598010
NGVSystem, Appendage Closure, Left AtrialClass III03
NGXStimulator, Muscle, Powered, For Muscle ConditioningClass II21 CFR 890.58501633
NGYCannula, Trocar, OphthalmicClass I21 CFR 886.4350111
NGZSusceptibility Test Plate, AntifungalClass II21 CFR 866.1640214
NHAAbutment, Implant, Dental, EndosseousClass II21 CFR 872.3630715225
NHBPolymer, Ear, Nose And Throat, Synthetic, AbsorbableClass II21 CFR 874.36201615
NHCCatheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents)Class II21 CFR 882.410032
NHFMonitor, Orthotic/ProstheticClass I21 CFR 890.302500
NHGEnzyme Immunoassay, Cortisol, SalivaryClass II21 CFR 862.120575
NHHDevice, Discharge, Electrostatic (For Pain Relief)Class II21 CFR 890.550020
NHIStimulator, Nerve, Electrical, Percutaneous (Pens), For Pain ReliefClass II21 CFR 882.5890130
NHJDevice, Positive Pressure Breathing, IntermittentClass II21 CFR 868.59052617
NHKResuscitator, Manual, Non Self-InflatingClass II21 CFR 868.5905100
NHLStimulator, Electrical, Implanted, For Parkinsonian SymptomsClass III04
NHMSheet, Recording, Breast ExaminationClass II21 CFR 884.299020
NHNPowered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain TherapyClass II21 CFR 890.5500547
NHOAnalyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)Class II21 CFR 868.150000
NHPAnalyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)Class II21 CFR 868.150010
NHQAnalyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)Class II21 CFR 868.150000
NHSAssay, Genotype, Hiv Drug Resistance, In VitroClass II21 CFR 866.395000