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

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    VARIOUSLY SIZED STERILE COTTON WOUND DRESSINGS

    FDA 510(k)
    FDA Unclassified ·Unknown

    APLION TOPICAL CARE SYSTEM

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    KATANA Cleaner, KATANA Cleaner (Trial)

    FDA 510(k)
    FDA Class 2 ·Dental

    ACCU-CHEK ® AVIVA COMBO

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code CGD·June 24, 2014

    KINETIX PLUS PTCA GUIDEWIRE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQX·November 4, 2010

    AXON ECLIPSE CONTROLLER

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED, INC.·Product code GWF·December 20, 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