BEUDAMED
    443 results · 16ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·REFLEX MODELS 8218 AND 822OE; REFLEX DDD MODELS 8223E AND 8224; AND SIMPLEX MODEL 8232 PULSE GENERATORS

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·DIVA FAMILY INCLUDES DIAMOND II, RUBY II, TOPAZ II, JADE 11, VITA DDDR, VITA DDD AND VITA VVIR

    Organ Care System (Ocs) Heart System

    FDA Pre-Market Approval
    FDA Class 3 ·OCS Heart System

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Sequentia™ LT INS (Model 977005), Vanta™ INS with AdaptiveStim™ (Model 977006)

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    FDA Pre-Market Approval
    FDA Class 3 ·Percept™ PC INS with BrainSense™ (Model B35200)

    Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

    FDA Pre-Market Approval
    FDA Class 3 ·Activa®, Percept™ and SenSight™ Deep Brain Stimulation Therapy System

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·DIVA FAMILY (INCLUDES DIAMOND II, RUBY II, TOPAZ II, JADE II, VITA DDDR, VITA DDD AND VITA VVIR) DEMA FAMILY (INCLUDES

    Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

    FDA Pre-Market Approval
    FDA Class 3 ·Organ Care System (OCS™) Liver

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·Diva family(includes Diamond II, Ruby II, Topaz II, Jade II, Vita DDDR, Vita DDD and Vita VVIR) Dema family, Selection A

    Permanent Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·CAPSURE(R) AND CAPSURE(R)SP LEADS

    Permanent Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·CAPSURE(R) AND CAPSURE(R) SP PACING LEADS

    Permanent Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·CARBON TIPPED LEAD MODELS 1085S,1085M,& 1085K

    Permanent Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·SWEET TIP RX STEROID ELUTING LEAD

    Permanent Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·FLEXTEND BIPOLAR, STEROID ELUTING, EXTENDABLE/ RETRACTABLE PACING LEAD

    Permanent Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·THINLINE/FINELINE

    Permanent Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·SUREFIX TM MODEL 5072 LEAD

    Permanent Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·PASSIVE PLUS DX ENDOCARDIAL, STEROID ELUTING, PASSIVE FIXATION PACING LEADS

    Permanent Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·PHILOS FAMILY OF PULSE GENERATORS

    Permanent Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·ENDOCARDIAL PACEMAKER LEAD W/CARBON TIP

    Permanent Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·CARBON TIPPED LEAD ALT.PROD.TRAYS