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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    UNI-PUMP 200

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Active™

    FDA UDI
    NEXUS SPINE, L.L.C.·B6788210390·Cervical Tray Fully Assembled - Active System

    BOWTI ANTERIOR BUTTRESS STAPLE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM

    FDA 510(k)
    FDA Class 1 ·Microbiology

    QUATTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL NEUROMODULATION·Product code GZB·May 7, 2014

    FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC., USA·Product code NBW·October 18, 2007

    REPLY

    FDA Adverse Event
    Injury ·SORIN CRM S.R.L.·Product code NVZ·October 26, 2012

    Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.

    FDA Enforcement
    Class II ·Terminated·STERILMED, INC.·December 16, 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