BEUDAMED
    9 results · 26ms · Sources: EU EUDAMED, US FDA

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    GIANTURCO-WALLACE TRACHEOBRONCHIAL Z STENT

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690199076·AK3 Congruent Insert Trial Size 4, 11mm

    N.A.

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011891411000·1 case dinamique m, McLaughlin 22 / For furthe...

    Ah!Yes Ob Coco Personal Lubricant

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    KNEEALIGN SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·June 24, 2014

    AUTOMATED PD SET W/CASSETTE4 PRONG

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 4, 2010

    9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 6, 2012

    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012