BEUDAMED
    7 results · 19ms · Sources: EU EUDAMED, US FDA

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    BIO MEDICUS BIO PUMP MODEL BP-80

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NightGuard Aire Max

    FDA 510(k)
    FDA Class 2 ·Dental

    MODIFICATION TO: AURORA

    FDA 510(k)
    FDA Class 2 ·Radiology

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2014

    DISCOVERY

    FDA Adverse Event
    Injury ·CPI PLANT - ST. PAUL·Product code NVZ·October 4, 2010

    ULTRACISION HARMONIC ACE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·November 30, 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