BEUDAMED
    11 results · 19ms · Sources: EU EUDAMED, US FDA

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    DISPOSABLE THERMOMETER COVERS AND SHEATHS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    FRIENDSHIP MEDICAL DISPOSABLE PRE-GELLED AG / AGCL SURFACE ELECTRODE

    FDA 510(k)
    FDA Class 2 ·Neurology

    MODIFICATION TO: VIEWGT ELECTRONIC PORTAL IMAGING DEVICE (EPID)

    FDA 510(k)
    FDA Class 2 ·Radiology

    TECNIS 1-PIECE

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code HQL·May 14, 2013

    ARCHITECT TOTAL T3

    FDA Adverse Event
    Malfunction ·A.I.D.D LONGFORD·Product code CDP·September 23, 2014

    ZOOM CRITICAL CARE BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·April 29, 2011

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·August 8, 2022

    SMR REVERSE FINNED HUMER. BODY

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A·Product code PHX·June 14, 2023

    Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000

    FDA Enforcement
    Class I ·Ongoing·Covidien·November 8, 2023

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 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