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

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    EI-CANDIDA ENZYME IMMUNOASSAY EI1001

    FDA 510(k)
    FDA Class 2 ·Microbiology

    CARDIOMEMO

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ANEROID SPHYGMOMANOMETER, MODEL BK2002

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HEARTSTART FRX

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

    2214133-2012-00181

    FDA Adverse Event
    Malfunction ·November 22, 2012

    GREENLIGHT ADDSTAT

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·September 22, 2010

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021