BEUDAMED
    7 results · 34ms · Sources: EU EUDAMED, US FDA

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    THE SMITHCOT

    FDA 510(k)
    FDA Class 1 ·General Hospital

    INTRAOPERATIVE RADIATION THERAPY DEVICES

    FDA 510(k)
    FDA Class 2 ·Radiology

    TRIGEMINAL SCISSORS

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·January 16, 2014

    TENDRIL SDX

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 10, 2010

    6800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 5, 2012

    DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·July 30, 2014