BEUDAMED
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    VIGGO INSUFLON

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Cios Select

    FDA 510(k)
    FDA Class 2 ·Radiology

    AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    REALSEAL

    FDA Adverse Event
    Injury ·SYBRONENDO·Product code EKM·June 18, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·December 20, 2012

    6800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 11, 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

    Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 24, 2021