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

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    SUR-FIT UROSTOMY POUCH W/ACCUSEAL

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209132591·

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209135950·

    DENTSPLY DENTURE CLEANER

    FDA 510(k)
    FDA Class 1 ·Dental

    DEPUY SIGMA XLK TIBIAL INSERTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TELESCOPIC STRUT LONG HOFFMANN LRF LENGTH: 177-277MM (RED)

    FDA Adverse Event
    Injury ·STRYKER TRAUMA SELZACH·Product code KTT·May 30, 2014

    PLM A+ SPANISH DEVIC

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·November 13, 2012

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 11, 2015

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018