BEUDAMED
    8 results · 23ms · Sources: EU EUDAMED, US FDA

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    ERBEFLO 2 Disposable Tubing System

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

    Oticon

    FDA UDI
    Oticon A/S·05707131339201·SIYA 2, MRITE 312 2.4G NFM PB C091

    CARESTREAM DRYVIEW 5850 LASER IMAGER

    FDA 510(k)
    FDA Class 2 ·Radiology

    ARCOS INTERLOCKING DISTAL STEMS

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    E SERIES DEFIBRILLATOR

    FDA Adverse Event
    Death ·ZOLL MEDICAL CORPORATION·Product code MKJ·July 28, 2011

    OPTIFLUX 160NRE DIALYZER FINISHED ASSY.

    FDA Adverse Event
    Malfunction ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FJI·June 21, 2013

    ENDURANT

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·October 21, 2014

    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