BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    IRRIGATION/ASPIRATION TUBING SET

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CAMBRIDGE HEART MODEL CH 2000 CARDIAC DIAGNOSTIC SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER

    FDA 510(k)
    FDA Class 2 ·Radiology

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Injury ·ROCHE INSULIN DELIVERY SYSTEMS INC·Product code LZG·November 23, 2010

    TELIGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 11, 2013

    ECHELON LINEAR CUTTER

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 3, 2014

    X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, AB6224, AB6318, AB6320, AB6322, AB6324, AB6418, AB6420, AB6422, AB6424, AB6522, AB6524, AB6A18, AB6A20, AB6A22, AB6A24, AB6C18, AB6C20, AB6C22, and AB6C24.

    FDA Enforcement
    Class II ·Ongoing·Coloplast Manufacturing US, LLC·January 22, 2025