BEUDAMED
    4 results · 21ms · Sources: EU EUDAMED, US FDA

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    BREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS Utilized as a walking aid.

    FDA Recall
    Open, Classified ·Breg Inc·Product code ITJ·September 13, 2023

    with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, 006653, an accessory to ventilator device, Vivo 45LS. intended for partial insertion into a patient's mouth (in between the lips) to facilitate access to the respiratory system.

    FDA Recall
    Open, Classified ·Breas Medical, Inc.·Product code NOU·October 13, 2023

    Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation Model Number: 230000 If the recalled product is a software, include version number: firmware versions 5.0.5 or earlier

    FDA Recall
    Open, Classified ·Breas Medical, Inc.·Product code NOU·June 2, 2022

    Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for patients who require invasive or non-invasive mechanical ventilation, Model/Catalog Number: 230000 (230016, 230216)

    FDA Recall
    Open, Classified ·Breas Medical, Inc.·Product code NOU·July 25, 2024