BEUDAMED
    7 results · 27ms · Sources: EU EUDAMED, US FDA

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    NEXXT MATRIXX® SI System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Catalys™ Precision Laser System

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    AneuGuide

    FDA 510(k)
    FDA Class 2 ·Radiology

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·November 11, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 12, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 23, 2013

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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