BEUDAMED
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    PathLoc Lumbar Interbody Fusion Cage System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ISOLA POLYAXIAL WASHER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PHYSIOLOGICAL MONITOR, PATIENT MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code FTL·May 30, 2013

    CAPSURE SP NOVUS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 16, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 25, 2014

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023