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

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    ASO SURE PLUS

    FDA 510(k)
    FDA Class 1 ·Microbiology

    STAR Apollo Mapping System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INJEX NEEDLE-FREE INJECTION SYSTEM; ROJEX NEEDLE-FREE INJECTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 30MM

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code KTT·July 15, 2019

    ACRYSOF TORIC

    FDA Adverse Event
    Injury ·ALCON RESEARCH . LTD/HUNTINGTON·Product code HQL·May 8, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 6, 2012

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 5, 2015

    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