BEUDAMED
    384 results · 45ms · Sources: EU EUDAMED, US FDA

    Temporary Non-Roller Type Left Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella 2.5, Impella CP, Impella CP with SmartAssist

    Temporary Non-Roller Type Right Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella RP, Impella RP with Smart Assist, Impella $.0/LD

    Temporary Non-Roller Type Right Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella RP System

    Temporary Non-Roller Type Left Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0/LD and Impella 5.5 with SmartAssist

    Temporary Non-Roller Type Left Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·IMPELLA

    Temporary Non-Roller Type Left Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella 2.5, Impella CP, Impella CP with SmartAssist, and Impella 5.5 with SmartAssist

    Temporary Non-Roller Type Left Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·IMPELLA 2.5 SYSTEM

    Temporary Non-Roller Type Left Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·IMPELLA CP with Smart Assist

    Temporary Non-Roller Type Left Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella 2.5

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·IPULSE CIRCULATORY SUPPORT SYSTEM

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·42 FR VENTRICULAR CANNULA WITH INTEGRATED SEWING CUFF

    Ventricular (Assist) Bypass

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

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·AB5000/BVS 5000 CIRCULATORY SUPPORT SYSTEM

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·AB PORTABLE DRIVER

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·AB5000 CIRCULATORY SUPPORT SYSTEM

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·IPULSE CIRCULATORY SUPPORT SYSTEM

    Abiomed Europe GmbH

    Importer
    🇩🇪 Germany·1 Manufacturer

    Abiomed Europe GmbH

    Authorized representative
    🇩🇪 Germany·1 Manufacturer·13 Devices

    2817GB415210518A

    Certificate
    MDD Annex V·Abiomed Inc.·DNV MEDCERT GmbH·2 Basic UDI-DIs

    2817GB410190207

    Certificate
    MDD Annex II (excluding section 4)·Abiomed Inc.·DNV MEDCERT GmbH·5 Basic UDI-DIs