BEUDAMED
    7 results · 17ms · Sources: EU EUDAMED, US FDA

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    MICROSAMPLE COAGULATION ANALYSER, MODEL 110WP

    FDA 510(k)
    FDA Class 2 ·Hematology

    EMPOWR PS Knee System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR MODEL MO701K

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CARELINK

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code KRG·June 10, 2014

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code HXX·December 6, 2012

    ISYMM ASPHERIC INTRAOCULAR LENS

    FDA Adverse Event
    Malfunction ·HOYA SURGICAL OPTICS, INC.·Product code HQL·September 23, 2010

    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