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

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    OSTAR USB BLOOD PRESSURE MONITOR WITH SPECTRUM / P200 FOR UPPER ARM, AND M100 FOR WRIST TYPE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CHLORAPREP ONE STEP HI-LITE ORANGE

    FDA Adverse Event
    Malfunction ·CAREFUSION 213, LLC 0113·Product code KXF·October 12, 2021

    WELL LEAD ENDOTRACHEAL TUBE WITH EVACUATION LUMEN-ORAL

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ELECSYS IGE CALCHECK 5

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 14, 2013

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·September 23, 2014

    SM104 MSERIES W5TH WHL

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·April 29, 2011

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L131, ESSENTIO DR EL MRI Pacemaker

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