BEUDAMED
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    Pristina Serena Bright

    FDA 510(k)
    FDA Class 2 ·Radiology

    CARDIO MED

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AVEX CX2 AND AVEX CXI2 CERAMIC BRACKETS

    FDA 510(k)
    FDA Class 2 ·Dental

    ISOFLEX S

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC, CRMD·Product code NVN·January 13, 2014

    GYNECARE TVT SECUR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code PAH·June 27, 2013

    ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG

    FDA Adverse Event
    Injury ·COOK, INC.·Product code MIH·July 28, 2011

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020