BEUDAMED
    11 results · 18ms · 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.

    IV START TRAY

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TEGO CONNECTOR

    FDA Adverse Event
    Malfunction ·ICU MEDICAL, INC.·Product code FPA·December 15, 2014

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172971659·

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172972274·

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172971642·

    PBS, PBSW WITH CATIONS AND PHENOL RED

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    QUICK SAMPLER HOLDER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    GEMSTAR PAIN MGE SNG

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·April 9, 2014

    AUTOCLAVABLE INTERNAL HANDLES (MSERIES)

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORP.·Product code LDD·October 4, 2012

    PRECISION LINK

    FDA Adverse Event
    Malfunction ·Product code NBW·August 30, 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