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

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    STARPORT MODEL H3300AA

    FDA 510(k)
    FDA Class 1 ·Radiology

    MODIFICATION TO 3I PATIENT-SPECIFIC DENTAL ABUTMENTS AND OVERDENTURE BARS

    FDA 510(k)
    FDA Class 2 ·Dental

    Ennova Self-adhesive Electrode

    FDA 510(k)
    FDA Class 2 ·Neurology

    OT VERIO IQ METER

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

    ENPATH

    FDA Adverse Event
    Injury ·EXTERNAL MANUFACTURER·Product code LWS·October 4, 2010

    CAPIOX SX OXYGENATOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTN·November 27, 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