BEUDAMED
    2,736 results · 38ms · Sources: EU EUDAMED, US FDA

    Ventricular (Assist) Bypass

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

    Ventricular (Assist) Bypass

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

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM

    Ventricular (Assist) Bypass

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

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·HeartMate II Left Ventricular Assist System (LVAS)

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·CentriMag Circulatory Support System

    Ventricular (Assist) Bypass

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

    Ventricular (Assist) Bypass

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

    2021-MDD/QS-023, 2021-MDD/DE-024

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·BNC KOREA, Inc.·1 device

    Sterilizable Handles

    FDA UDI
    Baxter Medical Systems GmbH + Co. KG·00887761967267·Sterilizable Camera Handle, 1 pc

    Sterilizable Handles

    FDA UDI
    Baxter Medical Systems GmbH + Co. KG·00887761967274·Sterilizable ALC Handle, 1 pc

    Sterilizable Handles

    FDA UDI
    Baxter Medical Systems GmbH + Co. KG·00887761967250·Sterilizable Central Handle, 1 pc

    Light, Surgical, Instrument

    FDA classification
    FDA Class 2 ·Light, Surgical, Instrument

    Ventricular (Assist) Bypass

    FDA classification
    FDA Class 3 ·Ventricular (Assist) Bypass

    Spirit

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Active Optical Systems Ltd·1 device

    Body Shape

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Active Optical Systems Ltd·1 device

    Prime

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Top Engineering Sarl·1 device

    Skin Shape

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Top Engineering Sarl·1 device

    Forte - 718

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Top Engineering Sarl·1 device

    Optima

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Active Optical Systems Ltd·1 device