Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR

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 42 of 71
FDA product codes, page 42 of 71
CodeDevice nameClassRegulationClearancesRecalls
MAHHearing Aid, Bone Conduction, ImplantedClass II21 CFR 874.3302120
MAIFastener, Fixation, Biodegradable, Soft TissueClass II21 CFR 888.303022197
MAJCatheter, Percutaneous, Intraspinal, Short TermClass II21 CFR 868.512060
MALGraft, Vascular, Synthetic/Biologic CompositeClass II21 CFR 870.3450649
MAMDna-Probe, B And T LymphocyteClass II21 CFR 864.522010
MANAssay, InterleukinClass III00
MAODna-Probe, Human ChromosomeUnclassified01
MAQKit, Dna Detection, Human PapillomavirusClass III012
MARCyclosporine And Metabolites Serum AssayClass II21 CFR 862.123500
MAUEraser, Dental StainClass I21 CFR 872.685521
MAVSyringe, Balloon InflationClass II21 CFR 870.16505829
MAWMarker, Suture IdentificationClass I21 CFR 878.480010
MAXIntervertebral Fusion Device With Bone Graft, LumbarClass II21 CFR 888.3080896115
MAYProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic FinishClass II21 CFR 888.3353419
MBBBone Cement, AntibioticClass II21 CFR 888.3027197
MBDProsthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerClass III01
MBFProsthesis, Shoulder, Semi-Constrained, Metal/Polymer, UncementedClass II21 CFR 888.36703720
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerClass II21 CFR 888.3565146103
MBIFastener, Fixation, Nondegradable, Soft TissueClass II21 CFR 888.3040604113
MBJFastener, Fixation, Biodegradable, Hard TissueClass III10
MBLProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, PorousClass II21 CFR 888.33581312
MBPFiller, Bone Void, Osteoinduction (W/O Human Growth Factor)Class II21 CFR 888.30453141
MBQPeripheral Electromagnetic Field (Pemf) To Aid Wound HealingClass III02
MBSFiller, Bone Void, Non-OsteoinductionClass III00
MBTDna-Probe, Reagent, Histoplasma CapsulatumClass II21 CFR 866.332010
MBUSingle-Use Internal CondomClass II21 CFR 884.534000
MBVProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/PolymerClass II21 CFR 888.3560141
MBXStimulator, Thalamic, Epilepsy, ImplantedClass III00
MCATape, Surgical, InternalClass II21 CFR 878.330010
MCBAntigen, C. DifficileClass I21 CFR 866.2660104
MCCDna-Probe, Haemophilus Spp.Class II21 CFR 866.330020
MCDAntigen, Ebv, CapsidClass I21 CFR 866.323580
MCERespiratory Syncytial Virus - ElisaClass I21 CFR 866.348020
MCFUnit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), SterileClass I21 CFR 872.685551
MCGDna-Probe, Agent, ListeriaClass I21 CFR 866.335500
MCHClip, HemostaticClass II21 CFR 878.430034
MCIGraft, Vascular, Hemodialysis Access, Synthetic/Biological CompositeClass III00
MCKDevice, Voice AmplificationClass II21 CFR 874.373000
MCLKit, Test, In Vitro PeriodontalClass III00
MCMImplant, CochlearClass III032
MCNBarrier, Absorbable, AdhesionClass III03
MCPStimulator, Fetal, AcousticClass III00
MCSDna-Probe, Staphylococcus AureusClass I21 CFR 866.370010
MCTDna-Probe, Strep PneumoniaeClass I21 CFR 866.374010
MCVSpinal Pedicle Screw, Fixation, Appliance SystemClass III00
MCWCatheter, Peripheral, AtherectomyClass II21 CFR 870.487514634
MCXCatheter, Coronary, AtherectomyClass III014
MCYWound Dressing KitClass II21 CFR 880.507524101
MCZSuture Removal KitClass I21 CFR 878.48001516
MDAElastomer, Silicone, For Scar ManagementClass I21 CFR 878.4025810
MDBSystem, Blood CulturingClass I21 CFR 866.25606876
MDCDna-Probe - Blastomyces DermatitidisClass II21 CFR 866.306010
MDDDevice, Dermal ReplacementClass III03
MDEDna-Probe, Reagents, CryptococcalClass II21 CFR 866.316510
MDFDna-Probe, Reagents, Coccidioides ImmitisClass II21 CFR 866.313510
MDGSystem, Intrafallopian CannulaClass II21 CFR 884.453010
MDIProsthesis, Rib ReplacementClass II21 CFR 888.307021
MDJReagents, CysticercosisClass I21 CFR 866.320010
MDKDna-Probe, Reagents, StreptococcalClass I21 CFR 866.374042
MDLImplant, TransmandibularClass II21 CFR 872.476020
MDMInstrument, Manual, Surgical, General UseClass I21 CFR 878.48004476
MDPSeparator For Therapeutic Purposes, Membrane Automated Blood Cell/PlasmaClass III03
MDRBinder, Medical, TherapeuticClass I21 CFR 880.5160019
MDSSensor, Glucose, InvasiveClass III057
MDTElisa, Trichinella SpiralisClass I21 CFR 866.385001
MDUAntigen, Elisa, CryptococcusClass II21 CFR 866.316521
MDZCleaners, Medical DevicesClass II21 CFR 880.699222
MEAPump, Infusion, PcaClass II21 CFR 880.57253146
MEBPump, Infusion, ElastomericClass II21 CFR 880.572588109
MECDisinfector, Medical DevicesClass II21 CFR 880.6992231
MEDSterilant, Medical DevicesClass II21 CFR 880.68856421
MEFRing, Teething, Non-Fluid FilledClass I21 CFR 872.555011
MEGSyringe, AntistickClass II21 CFR 880.586016217
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateClass II21 CFR 888.3353160197
MEQSystem, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),ThermotherapyClass III09
MERStent, Urethral, Prostatic, Permanent Or Semi-PermanentClass III00
MESStent, Urethral, Bulbous, Permanent Or Semi-PermanentClass III00
MFADevice, Removal, Pacemaker Electrode, PercutaneousClass III00
MFDCannula, Intrauterine InseminationClass II21 CFR 884.5250291
MFEAgent, Injectable, EmbolicClass III02
MFJDevice, Endoscopic SuturingClass II21 CFR 876.150010
MFKLens, Multifocal IntraocularClass III21 CFR 886.360004
MFRStimulator, Brain, Implanted, For Behavior ModificationHumanitarian device exemption00
MFXVessel Guard Or Cover, To Facilitate Revision SurgeriesClass II21 CFR 870.347020
MFYEndothelial Cell Harvesting KitClass II21 CFR 870.407510
MGAAlpha-1 Microglobulin, Antigen, Antiserum, ControlClass I21 CFR 866.540021
MGBDevice, Hemostasis, VascularClass III012
MGIAspirator, UltrasonicClass III10
MGMC. Trachomatis (Chlamydia Group)Class I21 CFR 866.312003
MGOClosure, Wound, AdhesiveClass I21 CFR 878.401819
MGPDressing, Wound And Burn, OcclusiveUnclassified801
MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or BiologicUnclassified14514
MGRDressing, Wound And Burn, InteractiveClass III07
MGSHigh Performance Liquid Chromatography For CyclosporineClass II21 CFR 862.123500
MGUFluorescence Polarization Immunoassay For CyclosporineClass II21 CFR 862.123501
MGVRadioimmunoassay For CyclosporineClass II21 CFR 862.123500
MGXTest System, For Drugs Of AbuseClass III01
MGZValvulotomeClass II21 CFR 870.4885276
MHCNeedle, InterosseousClass II21 CFR 880.557020
MHDPump, Infusion, Gallstone DissolutionClass II21 CFR 880.572510