BEUDAMED
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    ABSORBER, ANESTHESIA CIRCLE SYS, CO2

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    XCage™ Interbody Fusion System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SURGICOUNT SAFETY-SPONGE SYSTEM

    FDA 510(k)
    FDA Class 1 ·General Hospital

    APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code KTW·April 18, 2014

    CARTO XP EP NAVIGATION SYSTEM

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER (ISRAEL), LTD.·Product code DQK·June 1, 2007

    CE INFUSOR LV 5, 12 PACK

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·July 16, 2010

    Model Number U228, VISIONIST CRT-P EL MRI

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