2 results
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites Catalog Number: 301012
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·December 20, 2023
PVA, PREVENT is an FDA-authorized emergency ventilator designed to treat patients suffering from COVID-19 respiratory failure. This motorized device automatically compresses a resuscitator bag to provide air to the lungs of a COVID-19 patient, eliminating the human error and fatigue that results from manual actuation. PREVENT is indicated for emergency resuscitation with appropriate patient monitoring on adult patients that require mechanical respiratory support.
FDA Enforcement
Class II
·Ongoing·Precision Valve & Automation,Inc·August 26, 2020