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

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    NYLON LINER GLOVES

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    VARIAX

    FDA UDI
    Stryker GmbH·07613327125818·Posterior Medial Elbow Plate Insert

    PADLOCK CLIP EFTR Kit (00713229)

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

    ACON OPI ONE STEP OPIATE TEST STRIP AND ACON OPI ONE STEP OPIATE TEST DEVICE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ACRYSOF

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·June 19, 2014

    RENAL - DISPOSABLE

    FDA Adverse Event
    Injury ·Product code KDJ·December 29, 2010

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·February 2, 2013

    Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.

    FDA Enforcement
    Class II ·Terminated·Capintec Inc·April 1, 2020

    Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), 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 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), 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), Cardio Vascular-Allura (722400);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 27, 2026