BEUDAMED
    10 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.

    OLLI 565

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEGA PLUS MIS SPINE SYSTEM

    FDA UDI
    BK MEDITECH CO.,LTD.·08809916493034·Multi-Axial Fenestrated Screw, Ø10.5 x 40mm, Ø5...

    REGENECARE WOUND GEL

    FDA 510(k)
    FDA Unclassified ·Unknown

    BIOBOLT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SCS LEAD

    FDA Adverse Event
    Malfunction ·NEURO - VILLALBA·Product code LGW·December 12, 2011

    COMPLETE DOUBLE MOIST

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS INC.·Product code LPN·April 30, 2012

    COOK CELECT NAVALIGN FEMORAL VENA CAVA FILTER SET

    FDA Adverse Event
    Malfunction ·WILLIAM COOK EUROPE·Product code DTK·April 10, 2014

    TARGIS SYSTEM

    FDA Adverse Event
    Injury ·UROLOGIX, INC.·Product code MEQ·August 25, 2010

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    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