BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    Powder Free Nitrile Examination Gloves, Blue Chemotest

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CHILLIT

    FDA 510(k)
    FDA Class 2 ·Dental

    EVADYNE TEMPORARY CROWN AND BRIDGE RESIN

    FDA 510(k)
    FDA Class 2 ·Dental

    EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·October 29, 2014

    DORSAL SMARTLOCK DR PLATE, STANDARD, LEFT

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS FREIBURG·Product code HRS·August 6, 2011

    THINLINE II

    FDA Adverse Event
    Injury ·GUIDANT ANGLETON/ST. PAUL·Product code NVN·July 8, 2013

    StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-TRL-BO US and 2. FR4A-TR-BO - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.

    FDA Enforcement
    Class II ·Ongoing·Stimwave Technologies Inc·September 9, 2020