BEUDAMED
    7 results · 22ms · Sources: EU EUDAMED, US FDA

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    HEPARINIZED ARTERIAL SCREEN BLOOD FILTER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    WILSON-COOK BILIARY MOTILITY CATHETER

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

    TENZCARE DUAL-CHANNEL STIMULATOR

    FDA 510(k)
    FDA Class 2 ·Neurology

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·November 16, 2010

    HI SUMMIT

    FDA Adverse Event
    Malfunction ·HOWARD MEDICAL·Product code NXB·January 3, 2013

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 27, 2014

    Pipeline Flex Embolization Device

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