BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    HITACHI 736

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ES-Series

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFICATION TO XIA 4.5 SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ATTAIN COMMAND

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code DQY·June 10, 2014

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·October 7, 2010

    10MM, 33CM PEEK MONOPOLAR HANDLE

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY SAN JOSE·Product code KOG·October 30, 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