BEUDAMED
    11 results · 27ms · Sources: EU EUDAMED, US FDA

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    METRONIC MODEL F7700 HEART VALVE SIZERS

    FDA 510(k)
    FDA Class 1 ·Cardiovascular

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111220937·GUYON SOUND W/THREAD 12FR

    Shoreline ACS

    FDA UDI
    Seaspine Orthopedics Corporation·10889981177676·12mm, 3-Hole Threaded Anterior Plate

    NAR Kit

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209111220·STATION, BLEEDING CONTROL, INDV ADV BCD NYLON -...

    DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN BLUE COLOR

    FDA 510(k)
    FDA Class 1 ·General Hospital

    eSensor Warfarin Sensitivity Saliva Test

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    OT ULTRALINK METER

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

    VITALITY

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

    MEDEX LOGICAL PRESSURE MONITORING SYSTEM

    FDA Adverse Event
    SMITHS MEDICAL ASD, INC.·Product code BYX·November 14, 2012

    Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.

    FDA Enforcement
    Class I ·Terminated·Animas Corporation·April 10, 2013

    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