BEUDAMED
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    RayStation 11B

    FDA 510(k)
    FDA Class 2 ·Radiology

    KeyPrint

    FDA UDI
    Keystone Industries·H66841101411·KeySplint Hard Pink 1kg

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613154546275·Screwdriver Blade F.2.0/2.3mm, MP Screws

    MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    KENSEY NASH BONE VOID FILLER XC

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BARRIGEL INJECTABLE GEL

    FDA Adverse Event
    Malfunction ·PALETTE LIFE SCIENCES·Product code OVB·June 24, 2024

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 3, 2014

    AC POWER MODULE

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·August 11, 2011

    QUADRA ASSURA CRT-D, DF4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 11, 2013

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025