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

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    CALCIUM ASSAY KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HAnano InterFuse(R) Modular Interbody

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    G.R.A.M. SLIDE

    FDA 510(k)
    FDA Class 1 ·Microbiology

    SPECIFIC DEVICE NOT REPORTED

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·September 11, 2024

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·February 20, 2014

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·November 21, 2012

    SIGMA PLI XLK INS 2.5 8MM

    FDA Adverse Event
    Injury ·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code JWH·September 17, 2010

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017