BEUDAMED
    7 results · 25ms · Sources: EU EUDAMED, US FDA

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    KVM ISOTONIC FLUSH SOLUTION

    FDA 510(k)
    FDA Class 1 ·Hematology

    COR DOT CMV

    FDA 510(k)
    FDA Class 2 ·Microbiology

    VENTREZYME THEOPHYLLINE IMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    DEFIBRILLATION ELECTRODES

    FDA Adverse Event
    Death ·CARDIAC SCIENCE CORPORATION·Product code MKJ·June 11, 2014

    SERVO-I

    FDA Adverse Event
    MAQUET·Product code CBK·October 14, 2010

    ENDURANT II

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