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

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    HEMATASTAT H-70

    FDA 510(k)
    FDA Class 2 ·Hematology

    MODIFICATION TO: NANOCROSS 0.14 OTW PTA DILATATION CATHETER, MODELS AB14W020210090, AB14W020210150

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    IS-III active System_S-narrow Type

    FDA 510(k)
    FDA Class 2 ·Dental

    DRIVING CAP/THREADED

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code LXH·February 7, 2022

    GREENLIGHT ADDSTAT

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·October 28, 2010

    PROMOTE PLUS CRT-D

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL INC. CRMD·Product code NIK·January 13, 2014

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·December 31, 2012

    DRIVING CAP/THREADED

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code LXH·September 12, 2025

    DRIVING CAP/THREADED

    FDA Adverse Event
    Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code LXH·May 7, 2019

    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