BEUDAMED
    8 results · 21ms · 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 ×

    INTRAVASCULAR ADMINISTRATION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Elos Accurate Hybrid Base

    FDA 510(k)
    FDA Class 2 ·Dental

    DEVILBISS INTELLIPAP/SLEEPCUBE BILEVEL S/ST

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CER OPTION TYPE 1 TPR SLEVE +6

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·April 18, 2019

    ESSURE

    FDA Adverse Event
    Injury ·BAYER·Product code HHS·June 24, 2014

    HOMECHOICE CYCLER-REFURBISHED

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·November 5, 2010

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 31, 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