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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    CRANIOFIX AND CRANIOFIX2 TITANIUM CLAMP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    INTRASTENT DOUBLESTRUT XS STENT

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

    ANALYST PANELS + ANALYTICAL TEST ROTOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·November 23, 2016

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·January 14, 2026

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code CGA·July 27, 2016

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code NBW·September 28, 2016

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·December 13, 2016

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·October 26, 2016

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code NPT·April 8, 2013

    BIPOL LEAD MODEL 300

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·March 21, 2011

    BD PARADIGM LINK GLUCOSE MONITOR

    FDA Adverse Event
    Malfunction ·NOVA BIOMEDICAL CORP.·Product code NBW·May 9, 2008

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·January 16, 2017

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·July 26, 2016

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·September 12, 2016

    The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018