BEUDAMED
    9 results · 20ms · 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 ×

    REVERSIBLE HYDROCOLLOID IMPRESSION MAT

    FDA 510(k)
    FDA Class 2 ·Dental

    IMAGEDESK

    FDA 510(k)
    FDA Class 2 ·Radiology

    WOUND PROTECTOR

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Lens, Contact (Polymethylmethacrylate)

    FDA Pre-Market Approval
    FDA Unclassified ·PARAPERM O2 CONTACT LENS CLEAR & BLUE

    Lens, Contact (Polymethylmethacrylate)

    FDA Pre-Market Approval
    FDA Unclassified ·PARAPERM O2 CONTACT LENS CLEAR & BLUE

    X SERIES OPERT DEFIBRILLATOR PAD

    FDA Adverse Event
    Malfunction ·ZOLL·Product code MKJ·May 15, 2014

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·November 5, 2012

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 4, 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