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

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    XLS-300 XENON LIGHT SOURCE

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

    BIOTRACK THEOPHYLLINE QUALITY CONTROLS

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    PuraStat

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

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·January 14, 2013

    FLEXTEND II

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVN·January 10, 2011

    UNKNOWN_SPINE_PRODUCT

    FDA Adverse Event
    Injury ·STRYKER SPINE-FRANCE·Product code NKB·July 23, 2014

    ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·April 1, 2020