BEUDAMED
    10 results · 26ms · Sources: EU EUDAMED, US FDA

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    Vertaplex® High Viscosity (HV) Radiopaque Bone Cement

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HNM Women Care

    FDA UDI
    HNM STAINLESS, LLC.·00812171028420·PESSARY, GELLHORN #4, 2.5"

    HEATLUX

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    VALO CORDLESS

    FDA 510(k)
    FDA Class 2 ·Dental

    RINGLOC-X E1 H/W 56/32MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LPH·April 11, 2025

    EXAM GLOVES NITRILE

    FDA Adverse Event
    KIMBERLY-CLARK HEALTH CARE·Product code FMC·June 6, 2013

    LANDMARX EVOLUTION

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·June 22, 2011

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 9, 2008

    TORNIER PERFORM ANATOMIC AUG MED RIGHT GLENOID 15 DG

    FDA Adverse Event
    Injury ·TORNIER INC·Product code KWS·March 8, 2024

    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