BEUDAMED
    8 results · 33ms · Sources: EU EUDAMED, US FDA

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    IDI ISOTONIC DILUENT

    FDA 510(k)
    FDA Class 1 ·Hematology

    LED Light Therapy Mask (RT01)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    BULLDOG BIOPSY VALVE, OLYMPUS AND FUJINON;PENTAX COMPATIBLE;DISPOSABLE RRIGATING ADAPTOR, STERILE AND NON-STERILE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 31, 2014

    ZELTIQ EZ APP 8.0

    FDA Adverse Event
    Injury ·ZELTIQ AESTHETICS INC.·Product code OOK·November 12, 2012

    IAB: 8 FR - 30 CC

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code DSP·August 27, 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

    Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.

    FDA Enforcement
    Class II ·Terminated·STERILMED, INC.·December 16, 2015