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

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    BATTERY PACKS (OTHER THAN CV)

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    SERUM, BLOOD UREA NITIOGEN

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Voyant System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    2520274-2013-05357

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code JDW·September 4, 2013

    2520274-2013-05366

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code JDW·September 6, 2013

    2520274-2013-05365

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HSB·September 6, 2013

    2520274-2013-05358

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code HWC·September 6, 2013

    2520274-2013-05356

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code HSB·September 6, 2013

    ENDURANT II

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·June 18, 2014

    HILL-ROM

    FDA Adverse Event
    Malfunction ·HILL-ROM·Product code HDD·October 20, 2010

    UNKNOWN STIMULATOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LGW·December 20, 2012

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

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