BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    LIBERATOR/STROLLER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    TATTOOSTAR FAMILY

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with Stylet

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

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    FDA Adverse Event
    Injury ·THORATEC CORP.·Product code DSQ·April 7, 2014

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·September 26, 2012

    HAND PLATING SYSTEM 1.6MM T PLATE

    FDA Adverse Event
    Other ·OSTEOMED LP·Product code HRS·July 9, 2010

    LOFRIC ELLE

    FDA Adverse Event
    Malfunction ·WELLSPECT HEALTHCARE·Product code EZD·August 1, 2025

    LOFRIC ELLE

    FDA Adverse Event
    Malfunction ·WELLSPECT HEALTHCARE·Product code EZD·September 3, 2025

    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