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

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    Moda-flx Hemodialysis System and Cartridge

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

    da Vinci SP Surgical System

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

    Glidewell TuffSplint™ Appliance Resin

    FDA 510(k)
    FDA Unclassified ·Unknown

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·September 27, 2023

    ADAPTER SLEEVES 12/14 +5

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·November 6, 2014

    ADAPTER SLEEVE 11/13 +9

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·September 4, 2011

    ACRYSOF RESTOR

    FDA Adverse Event
    Injury ·ALCON - FORT WORTH/ALCON LABORATORIES, INC.·Product code HQL·July 16, 2013

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025