BEUDAMED
    11 results · 14ms · Sources: EU EUDAMED, US FDA

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    Altrua 2 pacemaker, Models: a) S701 b) S702 c) S722

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021

    Model Number L231, PROPONENT DR EL MRI Pacemaker

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

    Model Number S702, ALTRUA 2 DR SL Pacemaker

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

    Model Number U125, VALITUDE CRT-P EL

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

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    VISIONIST CRT-P pacemaker, Models: a) U225 b) U226 c) U228

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021

    Model Number L121 ESSENTIO DR EL Pacemaker

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

    ACCOLADE DR SL (Model L301)

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

    VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)

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

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024