BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    DIAFLEX NEPHROSTOMY BALLOON DILATOR

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

    Dental Unit

    FDA 510(k)
    FDA Class 1 ·Dental

    PURPLE/BLACK HEPARIN ASSAY CONTROL

    FDA 510(k)
    FDA Class 2 ·Hematology

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 31, 2014

    LIFEVEST WCD 3000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·November 12, 2012

    RF MULTIGEN

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code GXD·August 24, 2010

    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