BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    KSEA CALCUSON

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

    LumiCoil Platinum Fiducial Marker

    FDA 510(k)
    FDA Class 2 ·Radiology

    HYALOMATRIX PA

    FDA 510(k)
    FDA Unclassified ·Unknown

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·February 21, 2013

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·August 1, 2014

    FLO-GARD IV SOLUTION ADMIN SET

    FDA Adverse Event
    Malfunction ·Product code FPA·January 28, 2011

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024