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

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    BODYSCAN

    FDA 510(k)
    FDA Class 1 ·Radiology

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228708181·GC Initial™ MC Enamel E-58, 250g

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556701338·GC Initial™ MC Enamel E-58, 250g

    Craniomaxillofacial Distraction System (CMFD)

    FDA 510(k)
    FDA Class 2 ·Neurology

    MEDILOGAR4, MEDILOGAR12

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    1.1MM THREADED GUIDE WIRE 150MM

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code FZX·June 12, 2014

    HAKIM VALVE

    FDA Adverse Event
    Injury ·CODMAN & SHURTLEFF, INC. MEDOS S.A.·Product code JXG·October 6, 2010

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·December 12, 2012

    B125P Patient Monitor (with E-module slot option), REF 6160000-002

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·December 28, 2022