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

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    THE TURBOX ANALYSER SYSTEM COMPLEMENT C3 AND C4

    FDA 510(k)
    FDA Class 2 ·Immunology

    FlexCare 8906-75 200*75*13cm

    Device
    EU MDR · Eu Md Class 1 ·Vevia Finland Oy·On the market

    Dimension EXL High-Sensitivity Troponin I (TNIH) Assay

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SMITH & NEPHEW, INC. VLP FOOT PLATING, SCREW SYSTEM AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COONRAD/MORREY PIN/BUSHING REPLACEMENT KIT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JDC·June 2, 2014

    SM204 M-SERIES W/BIG WHEEL

    FDA Adverse Event
    Malfunction ·STRYKER CORP, MEDICAL DIVISION·Product code FPO·November 1, 2010

    ALIGN TO URETHRAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·BARD SHANNON LIMITED·Product code FTL·December 21, 2012

    STARDRIVE SCREWDRIVER SHAFT T8 55MM

    FDA Adverse Event
    Malfunction ·SYNTHES HAGENDORF·Product code HXX·November 15, 2016

    Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·July 22, 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