BEUDAMED
    4 results · 10ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

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

    FDA Enforcement
    Class II ·Ongoing·Breg Inc·November 15, 2023

    Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometric chemistry analyzer for clinical use. It is an in-vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids with Catalog Number C11137.

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·July 10, 2024

    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 Enforcement
    Class II ·Ongoing·Breas Medical, Inc.·December 6, 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 Enforcement
    Class II ·Ongoing·Breas Medical, Inc.·July 20, 2022