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

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    SPACELABS P.C. CARDIAC OUTPUT/PRESSURE MODULE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    1.5T PEDIATRIC HEAD AND SPINE ARRAY MODEL

    FDA 510(k)
    FDA Class 2 ·Radiology

    Reveal LINQ

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LIFECARE PCA 3 V5.06

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code MEA·April 15, 2014

    ENDOTAK RELIANCE

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVY·October 7, 2010

    EVIA DR-T

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG.·Product code NVZ·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