5 results
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30ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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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
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 Enforcement
Class I
·Ongoing·Breas Medical, Inc.·September 11, 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