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

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    PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM, PRECISION BLOOD GLUCOSE TEST STRIPS, PRECISION XTRA B-KETONE TEST ST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code CGA·July 27, 2016

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·October 19, 2016

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·July 26, 2016

    DURAZYME(R) CPK

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    GE DISCOVERY NM/CT 570C

    FDA 510(k)
    FDA Class 2 ·Radiology

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·February 28, 2013

    VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE

    FDA Adverse Event
    Malfunction ·ETHICON INC.·Product code GAM·August 6, 2014

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC - BROOKFIELD·Product code MMI·February 10, 2011