BEUDAMED
    5 results · 16ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class I ×

    Impella RP with SmartAssist; Product Number: 0046-0035;

    FDA Enforcement
    Class I ·Ongoing·Abiomed, Inc.·January 22, 2025

    EMBLEM S-ICD Model A209

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    PROPONENT DR SL (Model L201)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    Model Number U225 VISIONIST CRT-P EL

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025