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CodeDevice nameClass21 CFR510(k) (3y)
BSDAnalyzer, Gas, Nitrogen, Partial Pressure, Blood-Phase, Non-IndwellingClass 3
BWKStimulator, Electro-AcupunctureClass U23
DSQVentricular (Assist) BypassClass 3
DTHSuture, CardiovascularClass 3
DZGSuture, DentalClass 3
EFQGauze/Sponge, InternalClass U271
EPGStimulator, TransdermalClass 3
ESIPolymer, Natural-Absorbable Gelatin MaterialClass 32
EWDProtector, Hearing (Insert)Class U14
EWEProtector, Hearing (Circumaural)Class U1
EZZProsthesis, Vas DeferensClass 31
FAAReplacer, UrethralClass 31
FABReplacer, UreteralClass 3
FACValve, UreterovesicleClass 3
FAGProsthesis, Urethral SphincterClass 32
FAODevice, Cystometric, AirClass 3
FBYCooler, Esophageal And GastricClass 3
FBZCooler, ProstaticClass 3
FRODressing, Wound, DrugClass U707
FZCProsthesis, Arterial Graft, Bovine Carotid ArteryClass 3
HHYProsthesis, Suture, CerclageClass 3
HMNSuture, Nonabsorable, OphthalmicClass 31
HMOSuture, Absorbable, OphthalmicClass 3
HPXLens, Contact (Polymethylmethacrylate)Class U74
HTMStimulator, Osteogenesis, Electric, Battery-Operated, InvasiveClass 3
HWFProsthesis, LigamentClass 3
KGFAdhesive, Tissue For AneurysmorrhaphyClass 31
KGGTissue Adhesive For Use In Embolization Of Brain Arteriovenous MalformClass 3
KGMSilicone, Liquid, InjectableClass 3
KGNWound Dressing With Animal-Derived Material(S)Class U191
KJJCleanser, Root CanalClass U41
KSJSystem, Identification, Hepatitis B AntigenClass 3
KTAMedium, Contrast, RadiologicClass U8
KTJSystem, Test, Alpha-Fetoprotein, RiaClass 3
LAOEnzyme Immunoassay, MethotrexateClass U10
LBKNeurosurgical Ultrasonic InstrumentsClass U7
LCJTissue Expander And AccessoriesClass U55
LCLRadioimmunoassay, PhencyclidineClass U11
LCMEnzyme Immunoassay, PhencyclidineClass U88
LDKDevice, Sensing, Optical ContourClass U8
LEIImplant, Anti-Gastroesophageal RefluxClass 3
LEZAids, Speech Training For The Hearing Impaired (Ac-Powered And PatientClass U3
LFAAids, Speech Training For The Hearing Impaired (Battery-Operated Or NoClass U2
LFBButton, Nasal SeptalClass U12
LFDSaliva, ArtificialClass U50
LFLInstrument, Ultrasonic SurgicalClass U158
LGWStimulator, Spinal-Cord, Totally Implanted For Pain ReliefClass 3
LHDDevice, Fertility Diagnostic, ProceptiveClass U24
LHEController, Closed-Loop Blood GlucoseClass 3
LHYElectrode, Stabilized Epidural SpinalClass 3
LIIMonitor, Intracranial Pressure, ImplantedClass 3
LILMonitor, Penile TumescenceClass U26
LIWFibrillator, AcClass U
LJECatheter, NephrostomyClass U56
LKBPad, Alcohol, Device DisinfectantClass U25
LKKPump, Infusion, Implanted, ProgrammableClass 3
LKNSeparator, Automated, Blood Cell And Plasma, TherapeuticClass U27
LKVEnzyme Immunoassay, Fetal FibronectinClass 3
LKWLaser, NeurosurgicalClass 35
LKXDevice, Thermal, HemorrhoidsClass U18
LLEStimulator, Spinal-Cord, Implanted For Peripheral Vascular DiseaseClass 32
LLFLaser, Neurosurgical, ArgonClass 34
LLPLaser For Pain TherapyClass 3
LLQCap, Cervical, ContraceptiveClass 3
LLXCatheter, Sampling, Chorionic VillusClass 3
LMEMonitor, Blood-Flow, Cerebral, Thermal DiffusionClass 31
LMHImplant, Dermal, For Aesthetic UseClass 3
LMIImplant, Collagen For Non-Aesthetic UseClass 3
LMLLigaments And Tendons, SyntheticClass 3
LMNCeramics, Calcium Triphosphate/Hydroxypatite, Non-Load Bearing UsesClass 3
LMQDevice, Peritoneal Access, Subcutaneous, ImplantedClass 31
LMWSolution, Removal, CarriesClass 3
LMYMonitor, Skin Resistance/Skin Temperature, For Insulin ReactionsClass 3
LMZApplicator, Hyperthermia, InterstitialClass 3
LNBApplicator, Hyperthermia, Deep Heating, UltrasoundClass 3
LNCApplicator, Hyperthermia, Superficial, Rf/MicrowaveClass 3
LNLStimulator, Electrical For Sperm CollectionClass U1
LNMAgent, Bulking, Injectable For Gastro-Urology UseClass 3
LNQIntestinal StimulatorClass F
LNRSystem, Photopheresis, ExtracorporealClass 3
LNYCatheter, Percutaneous, Long Term, IntraspinalClass 3
LOADevice, Testicular HypothermiaClass 3
LOBDilator, Cervical, Synthetic, Osmotic, Pregnancy TerminationClass 3
LOCSystem, Rf/Microwave Hyperthermia, Cancer TreatmentClass 3
LOEStimulator, Invasive Bone GrowthClass 3
LOGCatheter, Balloon For Retinal ReattachmentClass 3
LOHSystem, Identification, Contact LensClass 3
LOILaser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior CapsuloClass 31
LOKKit, Test, Alpha-Fetoprotein For Neural Tube DefectsClass 3
LOTPulse-Generator, Program ModuleClass 3
LOZArtificial HeartClass 3
LPASystem, Esophageal PacingClass 3
LPBCardiac Ablation Percutaneous CatheterClass 3
LPCDevice, Angioplasty, Laser, CoronaryClass 3
LPFProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, CementedClass 3
LPGMaterial, Dressing, Surgical, Polylactic AcidClass 3
LPZContainer, Frozen Donor Tissue StorageClass U6
LQBMedical Computers And Software For Ophthalmic UseClass 32
LQDRecorder, Attention Task PerformanceClass U11
LQEImplant, Corneal, RefractiveClass 3
LQIHepatitis Delta Serological ReagentsClass 3
LQQColumns, Immunoadsorption In Extracorporeal SystemsClass 31
LQSSpermatocele, AlloplasticClass U1
LQYLocator, Root ApexClass U46
LRAHearing Aid, TactileClass U8
LRLCushion, HemorrhoidClass U3
LRQTracheostomy And Nasal Suctioning KitClass 16
LRRFirst Aid Kit With DrugClass N15
LSXController, Closed-Loop, Blood-PressureClass 3
LSYUltrasound, Hyperthermia, Cancer TreatmentClass 3
LSZVentilator, High FrequencyClass 3
LTAFluid, HysteroscopyClass 3
LTCHyaline Membrane Disease AssayClass 31
LTDParaquat AssayClass 32
LTGPaste, Injectable For Vocal Cord AugmentationClass 3
LTIImplant, Intragastric For Morbid ObesityClass 3
LTQCalibrator For Alpha-Fetoprotein In Mid-Pregnancy Maternal SerumClass 3
LTYFluid, Cytological CollectionClass 3
LWAProsthesis, Ligament, PtfeClass 3
LWBStimulator, Functional Neuromuscular, ScoliosisClass 3
LWEBone Marrow Collection/Transfusion KitClass 23
LWMDevice, Electrical Dental AnesthesiaClass U15
LWOPulse-Generator, Single Chamber, Sensor Driven, ImplantableClass 3
LWPImplantable Pulse Generator, Pacemaker (Non-Crt)Class 3
LWQHeart-Valve, MechanicalClass 3
LWRHeart-Valve, Non-Allograft TissueClass 3
LWSImplantable Cardioverter Defibrillator (Non-Crt)Class 3
LWTOccluder, Balloon, Vena-CavaClass 3
LWWPulse-Generator, Single Chamber, SingleClass 3
LWXDevice. Laser Peripheral AngioplastyClass 3
LWZTissue Graft Of Less Than 6mmClass 32
LXATissue Graft Of 6mm And GreaterClass 3
LXCMonitor, Pressure, IntracompartmentalClass U15
LXMManipulator, Plunger-Like JointClass U32
LXQCup, EyeClass U5
LXULaser For Wound HealingClass 3
LXVApparatus, Vestibular AnalysisClass U22
LXWColumn, Adsorption, Low Density, LipoproteinClass 31
LXYProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Class 3
LYIStimulator, Subcortical, Implanted For EpilepsyClass 3
LYJStimulator, Autonomic Nerve, Implanted For EpilepsyClass 3
LYXMedia, Corneal StorageClass U21
LZJProsthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-ConsClass U11
LZQTissue Adhesive For Ophthalmic UseClass 3
LZSExcimer Laser SystemClass 3
LZUPlug, PunctumClass U49
LZWMonitor, Spine CurvatureClass U5
MADCatheter, Percutaneous (Valvuloplasty)Class 3
MAEOccluder, Patent Ductus, ArteriosusClass 3
MAFStent, CoronaryClass 3
MANAssay, InterleukinClass 3
MAODna-Probe, Human ChromosomeClass U
MAQKit, Dna Detection, Human PapillomavirusClass 3
MBDProsthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, PorClass 3
MBJFastener, Fixation, Biodegradable, Hard TissueClass 31
MBQPeripheral Electromagnetic Field (Pemf) To Aid Wound HealingClass 3
MBSFiller, Bone Void, Non-OsteoinductionClass 3
MBXStimulator, Thalamic, Epilepsy, ImplantedClass 3
MCIGraft, Vascular, Hemodialysis Access, Synthetic/Biological CompositeClass 3
MCLKit, Test, In Vitro PeriodontalClass 3
MCMImplant, CochlearClass 3
MCNBarrier, Absorbable, AdhesionClass 3
MCPStimulator, Fetal, AcousticClass 3
MCVSpinal Pedicle Screw, Fixation, Appliance SystemClass 3
MCXCatheter, Coronary, AtherectomyClass 3
MDDDevice, Dermal ReplacementClass 3
MDPSeparator For Therapeutic Purposes, Membrane Automated Blood Cell/PlasClass 3
MDSSensor, Glucose, InvasiveClass 3
MEQSystem, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),TherClass 3
MERStent, Urethral, Prostatic, Permanent Or Semi-PermanentClass 3
MESStent, Urethral, Bulbous, Permanent Or Semi-PermanentClass 3
MFADevice, Removal, Pacemaker Electrode, PercutaneousClass 3
MFEAgent, Injectable, EmbolicClass 3
MFRStimulator, Brain, Implanted, For Behavior ModificationClass F
MGBDevice, Hemostasis, VascularClass 3
MGIAspirator, UltrasonicClass 31
MGPDressing, Wound And Burn, OcclusiveClass U80
MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or BiologicClass U145
MGRDressing, Wound And Burn, InteractiveClass 3
MGXTest System, For Drugs Of AbuseClass 3
MHEImplant, Auditory BrainstemClass 3
MHRTest, Anti-Tumor Cell SusceptibilityClass 3
MHYStimulator, Electrical, Implanted, For Parkinsonian TremorClass 3
MHZStimulator, Vestibular Acceleration, TherapeuticClass 31
MIEHeart-Valve, AllograftClass 3
MIGStrip, Test IsoniazidClass U2
MIHSystem, Endovascular Graft, Aortic Aneurysm TreatmentClass 3
MIKDevice, Ultrasonic, Thermal AblationClass 3
MIPImplanted Fecal Incontinence DeviceClass 3
MIRShunt, Portosystemic, EndoprosthesisClass 3
MJBAntigen, Cancer 549Class 3
MJOProsthesis, Intervertebral DiscClass 3
MJSContrast Media, UltrasoundClass 3
MJTProsthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, CClass 33
MJVDevice, Inflation, Middle EarClass U6
MKDStimulator, Functional Walking Neuromuscular, Non-InvasiveClass 3
MKNCatheter, Balloon, TranscervicalClass 3
MKQProcessor, Cervical Cytology Slide, AutomatedClass 3
MLQInhibitor, Peridural Fibrosis (Adhesion Barrier)Class 3
MLVTranscatheter Septal OccluderClass 3