BEUDAMED
    6 results · 20ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Enforcement × Classification: Class Iii × Clear all

    Cardiosave Hybrid

    FDA Enforcement
    Class III ·Ongoing·Datascope Corp.·December 24, 2025

    Cardiosave Rescue

    FDA Enforcement
    Class III ·Ongoing·Datascope Corp.·December 24, 2025

    Cardiosave Rescue IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation, Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85

    FDA Enforcement
    Class III ·Ongoing·Datascope Corp.·May 5, 2021

    Cardiosave Hybrid IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation, Model Numbers 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65

    FDA Enforcement
    Class III ·Ongoing·Datascope Corp.·May 5, 2021

    Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX

    FDA Enforcement
    Class III ·Ongoing·Datascope Corp.·June 21, 2023

    Battery Charging Station; Model: 0998-00-0802;

    FDA Enforcement
    Class III ·Ongoing·Datascope Corp.·March 25, 2026