BEUDAMED
    8 results · 29ms · 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.

    CORTISOL RIA KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Tranquil-L™

    FDA UDI
    NEXUS SPINE, L.L.C.·B6788228920·Curette #2 Ang, 9" Handle

    MTA2 ROOT AND PULP MATERIALS

    FDA 510(k)
    FDA Class 2 ·Dental

    ASCENSION SILLICONE MCP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    3M STERI-VAC STERILIZER/AERATOR 5XL

    FDA Adverse Event
    Other ·3M HEALTH CARE·Product code FLF·October 24, 2012

    SYMBIQ DCHANNEL 3.01

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·February 5, 2014

    PRIMABELLA

    FDA Adverse Event
    Other ·NEUROWAVE MEDICAL TECHNOLOGIES·Product code GZJ·August 27, 2010

    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