BEUDAMED
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    RESPIRE DISPOSABLE PULMONARY RESUSCITATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450495773·

    Selectra 3D Outer Guiding Catheters

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    1.5T GEM FLEX COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code CBK·May 14, 2014

    ABSOLUTE .035 SELF EXPANDING STENT SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR - VASCULAR SOLUTIONS·Product code FGE·November 12, 2010

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·December 21, 2012

    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