BEUDAMED
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    HENSCHKE AFTERLOADING APPLICATOR

    FDA 510(k)
    FDA Class 1 ·Radiology

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00613994287809·CASE 9871217 PLASTIC LID

    LIFESCAN ONE TOUCH ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN·Product code NBW·May 25, 2009

    DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BLADDERSCAN BVI 9400 ULTRASOUND

    FDA 510(k)
    FDA Class 2 ·Radiology

    COOK CELECT PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET

    FDA Adverse Event
    Injury ·WILLIAM COOK EUROPE·Product code DTK·December 14, 2020

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code CBK·April 16, 2014

    OLYMPUS EVIS EXERA COLONOVIDEOSCOPE

    FDA Adverse Event
    Injury ·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code FDF·October 11, 2010

    OT VERIO TEST STRIPS

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 12, 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