BEUDAMED
    7 results · 20ms · Sources: EU EUDAMED, US FDA

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    CMV ELISA TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SPIN CHEM REAGENT, DETERMINATION OF LDH-

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DELUXE HEAT WRAP/COLD WRAP

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ACCURUS 800CS

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·October 22, 2010

    PINNACLE PELVIC FLOOR REPAIR KITS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·December 31, 2012

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 24, 2014

    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