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

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    PERCUTANEOUS INTRODUCER KIT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NOVABONE POROUS-BONE GRAFT SCAFFOLD

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Anzai Respiratory Gating System

    FDA 510(k)
    FDA Class 2 ·Radiology

    ZIMMER TM REVERSE SHOULDER RETENTIVE POLY LINER

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code KWT·April 19, 2017

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

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

    LIGASURE ATLAS HANDSWITCHING 37CM

    FDA Adverse Event
    Malfunction ·COVIDIEN LLC (SHANGHAI)·Product code GEI·November 5, 2012

    98000

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·September 27, 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