BEUDAMED
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    Intracranial Aneurysm Flow Diverter

    FDA Pre-Market Approval
    FDA Class 3 ·Pipeline Flex Embolization Device

    Hepatitis A Test (Antibody And Igm Antibody)

    FDA Pre-Market Approval
    FDA Class 2 ·HAVAB-M (R) EIA

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·PROVIT MODEL VSA02 VERSION 6.1 SOFTWARE BUILD 63 SERVICE RELEASE FOR DEMA, DIVA AND SELECTION AFM FAMILIES OF PULSE GENS

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·TELIGEN PULSE GENERATORS

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)

    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

    FDA Pre-Market Approval
    FDA Class 3 ·Cardiac Resynchronization Therapy Defibrillator (CRT-D)

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Implantable Cardioverter Defibrillator (ICD)

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·MRI Pacemakers

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Accolade Family of Devices Pacemakers, and Cardiac Resynchronization Therapy Pacemakers (CRT-Ps)

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Merlin.net™ MN5000

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·COGNIS PULSE GENERATORS - MODELS N118 & N119

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·HeartMate 3 Left Ventricular Assist System

    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

    FDA Pre-Market Approval
    FDA Class 3 ·Cardiac Resynchronization Therapy - Pacemaker (CRT-P)

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·Merlin.net™ MN5000

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Accolade Family of Devices Pacemakers, and Cardiac Resynchronization Therapy Pacemakers (CRT-Ps)

    Leadless Pacemaker

    FDA Pre-Market Approval
    FDA Class 3 ·AVEIR™ Patient Transmitter, AVEIR™ Patient Transmitter Software, AVEIR™ Patient Trasmitter Wired Electrodes, Merlin.net™

    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

    FDA Pre-Market Approval
    FDA Class 3 ·Merlin.net™ MN5000

    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

    FDA Pre-Market Approval
    FDA Class 3 ·Accolade Family of Devices Pacemakers, and Cardiac Resynchronization Therapy Pacemakers (CRT-Ps)

    Device, Thermal Ablation, Endometrial

    FDA Pre-Market Approval
    FDA Class 3 ·Minerva Endometrial Ablation System

    Sealant, Dural

    FDA Pre-Market Approval
    FDA Class 3 ·SpineSeal Spine Sealant