BEUDAMED
    10,000 results · 41ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Artificial Heart

    FDA Pre-Market Approval
    FDA Class 3 ·SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·AFFINITY/INTEGRITY/VICTORY/ZEPHYR FAMILIES OF PACEMAKERS

    Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·CapSureFix Novus Lead

    Stent, Superficial Femoral Artery, Drug-Eluting

    FDA Pre-Market Approval
    FDA Class 3 ·Eluvia Drug-Eluting Vascular Stent System

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·HeartWare™ Ventricular Assist System (HVAD)

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·DRIVER AND MICRODRIVER CORONARY STENT SYSTEMS

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·XIENCE AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS

    Heart-Valve, Mechanical

    FDA Pre-Market Approval
    FDA Class 3 ·STARR EDWARDS SILASTIC BALL PROSTHESIS MODELS 1260 & 6120

    Drug-Eluting Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·IN PACT Admiral Paclitarel-Coated Balloon Catheter

    Defibrillator, Implantable, Dual-Chamber

    FDA Pre-Market Approval
    FDA Class 3 ·Lumos DR-T/VR-T

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·HEARTWARE VENTRICULAR ASSIST SYSTEM

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS

    Occluder, Patent Ductus, Arteriosus

    FDA Pre-Market Approval
    FDA Class 3 ·AMPLATZER DUCT OCCLUDER

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·KAPPA 700, VITATRON, KAPPA 900, ENPULSE, SIGMA, MEDTRONIC 350 SERIES, ENRHYTHM, AT500

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·LIBERTE CORONARY STENT SYSTEM

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM