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

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    WELCH ALLYN XENON 300 LIGHT SOURCE

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

    IMMUFUGE DISP. LINER

    FDA 510(k)
    FDA Class 1 ·Hematology

    PATHWAY

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 25, 2014

    TI ANTERIOR TENSION BAND PLATE

    FDA Adverse Event
    Injury ·SYNTHES (USA) ELMIRA·Product code KWQ·February 22, 2013

    RESTORE ADVANCED RECHARGEABLE

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·February 2, 2011

    Colonoscope, Model Number CF-HQ190L.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·March 6, 2024

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021