BEUDAMED
    7 results · 26ms · Sources: EU EUDAMED, US FDA

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    ELEGANCE NEONATAL TSH ELISA

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    QUIDEL HELICOBACTER PYLORI POSTIVE/NEGATIVE CONTR

    FDA 510(k)
    FDA Class 1 ·Microbiology

    QUEST HEART INSULATION PAD

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·December 22, 2010

    CONNECSCR F/DHS/DCS-WRENCH NO. 338.300

    FDA Adverse Event
    Malfunction ·SYNTHES·Product code HXC·January 30, 2013

    SIGMA STAB GVF INS 2.5 8MM

    FDA Adverse Event
    Injury ·DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS 121965·Product code JWH·July 15, 2014

    GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·July 30, 2014