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

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    TRACER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ENGSTROM CARESTATION, ENGSTROM PRO

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    OXYGENATOR, BLOOD BOS-10

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MERIT CUSTOM KIT

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·May 15, 2014

    POLYURETHANE CONTRAST INJECTION LINE

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code DXJ·October 8, 2010

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·December 20, 2012

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

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