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CodeDevice nameClass21 CFR510(k) (3y)
MLYVapocoolant DeviceClass U24
MMAOximeter, Fetal PulseClass 3
MMYLipoprotein, Low Density, RemovalClass 3
MNBDevice, Thermal Ablation, EndometrialClass 3
MNMReader, Cervical Cytology Slide, AutomatedClass 3
MNOSystem, Laser, Transmyocardial RevascularizationClass 3
MNQStimulator, Hypoglossal Nerve, Implanted, ApneaClass 3
MOAAnalyzer, Diagnostic, Fiber Optic (Colon)Class 3
MOMSystem, Hemodynamic, ImplantableClass 3
MOTIrradiator, Blood To Prevent Graft Versus Host DiseaseClass U16
MOUIntravascular Radiation Delivery SystemClass 3
MOZAcid, Hyaluronic, IntraarticularClass 3
MPKSemi-Constrained Metal/Polymer Finger Joint ProsthesisClass F
MPRStent, Bladder, FetalClass F
MPVImplant, Hearing, Active, Middle Ear, Partially ImplantedClass 3
MPWFiller, Recombinant Human Bone Morphogenetic Protein, Collagen ScaffolClass 3
MQCMouthguard, PrescriptionClass U71
MQOProsthetic Disc Nucleus DeviceClass N
MQTPump, Drug Administration, Closed LoopClass 3
MQZProsthesis, NailClass U4
MRAProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, CementClass 3
MRDMammary SizerClass U13
MRESolution, Sodium HyaluronateClass 3
MRJRing, EndocapsularClass 3
MRKSystem, Imaging, FluorescenceClass 3
MRMDefibrillator, Implantable, Dual-ChamberClass 3
MRUImplanted Subcortical Electrical Stimulator (Motor Disorders)Class F
MRWSystem, Facet Screw Spinal DeviceClass U78
MSISolution, Cleaning / Lubricating, Artificial EyeClass 31
MSKImmunoassay For Blood TacrolimusClass N
MTALens, Intraocular, PhakicClass 3
MTESystem, Pacing, Temporary, Acute, Internal Atrial DefibrillationClass 3
MTFTotal, Prostate Specific Antigen (Noncomplexed & Complexed) For DetectClass 3
MTGTest, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish PClass 3
MTHTray, Leukocyte TypingClass N
MTIKit, Cell Screening, FetalClass N
MTJWax, BoneClass U42
MTKKit, Sample Collection, HivClass 3
MTLMonitor,Test,Hiv-1Class 3
MTNTest, Syphilis, TreponemalClass N
MTOSoftware, Management, Microplate AssayClass N
MTPAntibody To Htlv-1, ElisaClass 3
MTQSoftware, Blood Virus ApplicationsClass N
MTRProgenitor Cell EnumerationClass 2
MTSVials, Challenge, EndotoxinClass N
MUQGlue, Surgical, ArteriesClass 3
MURGraft, Sclera, ReinforcementClass 3
MUZStimulator, Autonomic Nerve, Implanted (Depression)Class 3
MVCSystem, Test, Her-2/Neu, IhcClass 3
MVDSystem, Test, Her-2/Neu, Nucleic Acid Or SerumClass 3
MVFSystem, Laser, Photodynamic TherapyClass 3
MVGSystem, Laser, Fiber Optic, Photodynamic TherapyClass 3
MVKWearable Automated External DefibrillatorClass 3
MVLCord, RetractionClass U36
MVOKit, Test, Multiple, Drugs Of Abuse, Over The CounterClass U18
MVVDevice, AcupressureClass U13
MVWKit, Western Blot, Hiv-1Class N
MVXAntibody, Monoclonal Blocking, Hiv-1Class N
MVYMonoclonal, Hiv-1Class N
MVZSystem, Test, Home, Hiv-1Class 3
MWBKit, Test, Saliva, Hiv-1&2Class 3
MWDElectrosurgical, Radio Frequency, Refractive CorrectionClass 3
MWGSystem, Oxygen, AqueousClass 3
MWHPulmonic Valved ConduitClass F
MWMSensor, Electro-Optical (For Cervical Cancer)Class 3
MWOReagent, Blood Bank, Quality ControlClass N
MWQSystem, Test, Total Antioxidant StatusClass 3
MXMCap, Cooling (Infants)Class 3
MXQStent, Urethral, External Sphincter, PermanentClass 3
MYHSystem, Non-Coherent Light, Photodynamic TherapyClass 3
MYKKit, Cord Blood CollectionClass N
MYLAssay,Enzyme Linked Immunosorbent,Parvovirus B19 IggClass 3
MYMAssay,Enzyme Linked Immunosorbent,Parvovirus B19 IgmClass 3
MYPTest, Platelet AntibodyClass 2
MYSDevice, Ahf, Automated CryoprecipitationClass N
MYWIrradiation, Blood IndicatorsClass N
MYYSeparator, Semi-Automated, Blood ComponentClass 1
MYZKit, Test (Donors), For Bloodborne PathogenClass 2
MZATest, Equipment, Automated Bloodborne PathogenClass N
MZETest, Donor, CmvClass 2
MZHTest, Quantitative, For Hla, Non-DiagnosticClass N
MZITest, Qualitative, For Hla, Non-DiagnosticClass U
MZKSystem, Separation, Hematopoietic Stem CellClass 3
MZLKit, Test, Quality Control For EndotoxinClass N
NAFAntigen(Complexed),Prostate Specific,(Cpsa)Class 3
NAHSystem, Test, Tumor Marker, For Detection Of Bladder CancerClass 3
NANTester, Acoustic, Bone QualityClass 3
NAPCardiac Support Mesh WrapClass N
NAVGraft, Bypass, Coronary ArteryClass F
NAWMicrospheres RadionuclideClass 3
NAZStimulator, BladderClass F
NBESealant, PolymerizingClass 3
NBFProsthesis, RetinalClass F
NBNGenerator, Shock-Wave, For Pain ReliefClass 3
NCDTest, Immunity, Cell Mediated, Mycobacterium TuberculosisClass 3
NCJTelescope, Implantable, MiniatureClass 3
NCLImager, Breast, Electrical ImpedanceClass 3
NCOImplant, Cartilage, For Articular Cartilage RepairClass 3
NCTInstrument, Glucose, Noninvasive TechnologyClass 3
NCVLithotripter, Shockwave (For Treating Gallbladder Stones)Class 3
NDVTest, Ecarin Clotting Time (Ect)Class F
NEGFinger Semi-Constrained Pyrolytic Carbon Uncemented ProsthesisClass 3
NEKFiller, Recombinant Human Bone Morphogenetic Protein, Collagen ScaffolClass 3
NGMTest, Phencyclidine (Pcp), Over The CounterClass U
NGVSystem, Appendage Closure, Left AtrialClass 3
NHLStimulator, Electrical, Implanted, For Parkinsonian SymptomsClass 3
NIKDefibrillator, Automatic Implantable Cardioverter, With Cardiac ResyncClass 3
NIMStent, CarotidClass 3
NINStent, RenalClass 3
NIOStent, IliacClass 3
NIPStent, Superficial Femoral ArteryClass 3
NIQCoronary Drug-Eluting StentClass 3
NIUStent, Superficial Femoral Artery, Drug-ElutingClass 3
NIVCoronary Covered StentClass F
NJEIntracranial Neurovascular StentClass F
NJKValve, PulmonaryClass 3
NJLProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/PolymerClass 3
NKEPulse Generator, Pacemaker, Implantable, With Cardiac ResynchronizatioClass 3
NKMMitral Valve Repair DevicesClass 3
NLQSingle-Use Reprocessed Ultrasonic Surgical InstrumentsClass U27
NOXFiller, Bone Void, Synthetic PeptideClass 3
NPEMaterial, Embolization, Neurovascular, Polymerizing Or PrecipitatingClass 3
NPSTricuspid Valve Repair Device, Percutaneously DeliveredClass 3
NPTAortic Valve, Prosthesis, Percutaneously DeliveredClass 3
NPUProsthesis, Mitral Valve, Percutaneously DeliveredClass 3
NPVPulmonary Valve Prosthesis Percutaneously DeliveredClass F
NPWPercutaneously Delivered Prostheses And Tricuspid ValvesClass 3
NQCTest, Breath Analysis, Volatile Organic CompoundsClass F
NQKMaggots, MedicalClass U6
NQOProsthesis, Spinous Process Spacer/PlateClass 3
NQRSealant, DuralClass 3
NRAProsthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, MeClass 3
NRNLeeches, MedicinalClass U3
NRZAblation System, High Intensity Focused Ultrasound (Hifu), Mr-GuidedClass 3
NSDTest, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer DeClass 3
NSJRestoration, Noble MetalClass N
NSKDentures, PartialClass N
NSLDentures, FullClass N
NSMRestoration, ResinClass N
NSNRestoration, Resin, Crown And BridgeClass N
NSORestoration, Porcelain-Fused-To-MetalClass N
NSPRestoration, PorcelainClass N
NSQRestoration, Base MetalClass N
NSRProsthesis, OrthodonticClass N
NSSElectronic Media, NauseaClass N
NTGProsthesis, Ankle, Uncemented, Non-ConstrainedClass 3
NUKFor Export Only - Antigen, Anti-Cardiac, Indirect Fluorescent AntibodyClass N
NULFor Export Only - Antigen, Anti-Skeletal, Indirect Fluorescent AntibodClass N
NVNDrug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) PacClass 3
NVRIntervertebral Fusion Device With Bone Graft, Solid-Sphere, LumbarClass 36
NVYPermanent Defibrillator ElectrodesClass 3
NVZPulse Generator, Permanent, ImplantableClass 3
NWXCatheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), CuttiClass 3
NWYTest, Qualitative, Detection Of Dengue Igm And Igg AntibodiesClass N
NXGFluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene AmpliClass 3
NXJDenture, Cosmetic OnlyClass N
NXTProsthesis, Hip, Semi-Constrained, Metal/Metal, ResurfacingClass 3
NXWScaffold, Infrapopliteal, AbsorbableClass 3
NYQChromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/NeClass 3
NZCStent, Urethral, Prostatic, Semi-PermanentClass 3
NZFStatic Electricity-Emitting Device, Cosmetic UseClass N
NZKStimulator, Low Electric Field, Tumor TreatmentClass 3
OAAAid, Visual, For NauseaClass N
OADCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial FlutClass 3
OAECatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial FibrClass 3
OAFImplant, Hearing, Active, Middle Ear, Totally ImplantedClass 3
OAQElectronic Media, HyperacusisClass N
OAWCancer Monitoring Test System, Soluble Mesothelin-Related Peptides, EpClass F
OAYLight Source System, Diagnostic EndoscopicClass 3
OAZOne-Way Air-Leak ValveClass F
OBAPolymerizing, Neurovascular Embolization MaterialClass F
OBCOccluder, Internal Vessel, TemporaryClass 3
OBDBarrier, Adhesion, CardiovascularClass 3
OBRMouthguard, Over-The-CounterClass U46
OCBRt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer MetastasClass 3
OCECultured Epithelial AutograftClass F
OCKTransurethral Occlusion Insert, Urinary Incontinence-Control, FemaleClass 3
OCMSurgical Cardiac Ablation Device, For Treatment Of Atrial FibrillationClass 3
OCOMouthguard, Migraine/Tension HeadacheClass U3
ODHImplantable Bladder-Evacuation Electrical Stimulation SystemClass F
ODKRefractive Corneal ImplantClass F
ODSWound Covering (Composite Cultured Skin)Class F
ODTTissue Adhesive, Aortic AneurysmorrhaphyClass F
OEEDiagnostic Low Electric FieldClass 3
OGOIntraocular Pressure Lowering ImplantClass 3
OHAHeart Valve, More Than Minimally Manipulated AllograftClass U4
OIHYersinia Spp. ReagentsClass U1
OIRDiaphragmatic/Phrenic Nerve Laparoscopically-Implanted StimulatorClass 3
OJERight Ventricular Bypass (Assist) DeviceClass F
OJIBurn Kit With DrugClass N
OJNMycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-LinkClass 3
OJOEnzyme Linked Immunosorbent Assay For The Detection Of LipoarabinomannClass N
OJXDrug Eluting Permanent Left Ventricular (Lv) Pacemaker ElectrodeClass 3
OJZFiller, Recombinant Human Bone Morphogenetic Protein, Collagen ScaffolClass F
OKDFiller, Recombinant Human Bone Morphogenetic Protein, Collagen ScaffolClass F
OKNHyperthermia System, Bladder Cancer Treatment, With ChemotherapyClass 3
OKSLacrimal Stents And Intubation SetsClass U31
OLMDeep Brain Stimulator For Obsessive Compulsive Disorder (Ocd)Class F
OLQCross-Sectional Mammographic Xray SystemClass 3
OLROral Wound DressingClass U43