BEUDAMED
    7 results · 25ms · Sources: EU EUDAMED, US FDA

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    ULTRAZYME PLUS GPT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Embozene Color-Advanced Microspheres

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

    TQ SOLO AND SOLO PRO AND LS50 ACCESSORY AND MR4 MULTI RADIANCE THERAPY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 7, 2014

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·October 10, 2012

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code DYE·August 2, 2010

    3M" Steri-Vac" Gas Sterilizer/Aerators, Model #'s 4XL,5XL, 8XL The 3M" Steri-Vac" Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices. This gas sterilizer/aerator is intended for INDOOR USE ONLY.

    FDA Enforcement
    Class II ·Terminated·3M Company - Health Care Business·April 9, 2014