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

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    LDH-P (LACTIC DEHYDROGENASE) REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Artisan Power

    FDA UDI
    Artisan Power LLC·00819595015241·Replacement Memory Backup Battery for Alaris Me...

    FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168FV

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5

    FDA 510(k)
    FDA Class 2 ·Microbiology

    CAPSURE SP NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·June 10, 2014

    LIBERTE' CORONARY STENT DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code MAF·October 7, 2010

    TOTALCARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·October 29, 2012

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 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