BEUDAMED
    8 results · 27ms · Sources: EU EUDAMED, US FDA

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    VALVOTOMY KNIFE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1

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

    BIOMERIX VASCULAR OCCLUSION DEVICE AND LOADER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HEARTSTART FRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 14, 2014

    HEARTMATE II LVAS

    FDA Adverse Event
    Death ·THORATEC CORP.·Product code DSQ·November 19, 2012

    CONSTELLATION WITH LASER

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·September 22, 2010

    ENDOPLASTIC ELECTROSURGICAL DISSECTOR

    FDA Adverse Event
    Injury ·CAREFUSION, INC·Product code GEI·September 7, 2017

    EV3 Pipeline Flex Embolization Device with Flex Shield Technology

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