BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    SANISERV SURGICAL SLUSH SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613327556391·Facial iD MF 6 meshes

    BRUCELLA MEDIA

    FDA 510(k)
    FDA Class 1 ·Microbiology

    OPAL BOND MV

    FDA 510(k)
    FDA Class 2 ·Dental

    ICAST COVERED STENT

    FDA Adverse Event
    Injury ·ATRIUM MEDICAL CORPORATION·Product code JCT·June 10, 2014

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·November 3, 2010

    GORE EXCLUDER AAA ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code MIH·December 19, 2012

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020