BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    CANDELA INTRODUCER SHEATH SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Dextile Anatomical Mesh

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CONSTELLATION VISION SYSTEM

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·May 14, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·January 12, 2013

    INTEGRIS H5000

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code IZI·November 4, 2010

    Pipeline Flex Embolization Device

    FDA Enforcement
    Class I ·Ongoing·Micro Therapeutics Inc,·September 15, 2021