BEUDAMED
    7 results · 25ms · Sources: EU EUDAMED, US FDA

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    CODMAN PEDIATRIC HORSESHOE HEADREST

    FDA 510(k)
    FDA Class 1 ·Neurology

    ADVANCED HIP ASSESSMENT SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Radiology

    NUVANT, MOBILE CARDIAC TELEMETRY

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SUPREME QUAD CRD-2

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC.·Product code DRF·June 30, 2014

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·November 24, 2010

    INSIGNIA

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·January 11, 2013

    Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: FlexVision PC Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10/10 722005 722011 722027; Allura Xper FD20 722006 722012 722028; Allura Xper FD20 Biplane 722008 722013; Allura Xper FD20 Biplane OR Table 722025; Allura Xper FD20 OR Table 722023 722035; Allura Xper FD20/10 722029; Allura Xper FD20/15 722058; Allura Xper FD20/15 OR Table 722059; Allura Xper FD20/20 722038; Allura Xper FD20/20 OR Table 722039;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024