BEUDAMED
    7 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.
    Filters Regulation: Us FDA ×

    TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER

    FDA 510(k)
    FDA Class 2 ·Immunology

    STERILE WATER FOR RESPIRATORY THERAPY

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    KOWA VX-10 A

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    PENTA

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL - NEUROMODULATION·Product code GZB·June 9, 2014

    ECHELON*FLEX60 ARTICULATING

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code GDW·November 5, 2010

    LINOX SMART SD 65/18

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code LWS·November 21, 2012

    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