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

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    OMNIGRAPH 4000(ELECTROCARDIOGRAPH)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement

    FDA 510(k)
    FDA Class 2 ·Dental

    SMITH & NEPHEW CONTINUOUS LOOP FIXATION DEVICE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    OT VERIO IQ METER

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

    CONTAK RENEWAL

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·October 4, 2010

    EVAC 70 XTRA

    FDA Adverse Event
    Malfunction ·ARTHROCARE CORPORATION·Product code GEI·November 14, 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