BEUDAMED
    7 results · 21ms · Sources: EU EUDAMED, US FDA

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    CapKlenZ

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NEXUS PRESSURE RATED EXTENSION SETS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SFI-BAR IMPLANT ADAPTER STRAUMANN, SFI-BAR IMPLANT ADAPTER FOR NEOSS IMPLANT

    FDA 510(k)
    FDA Class 2 ·Dental

    SURFLASH PLUS SAFETY IV CATHETER

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION - KOFU·Product code FOZ·October 22, 2014

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·August 5, 2011

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·June 18, 2013

    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