2 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Cepheid Xpert MRSA/MRSA NxG Control Panel (Catalog #8195) UDI: 70845357041226 Product Usage: On April 9, 2019, Microbiologics sent ACTION REQUIRED: MEDICAL DEVICE CORRECTION emails to their direct US consignees requesting them to complete a MEDICAL DEVICE CORRECTION FORM indicating how much product they had on hand.
FDA Enforcement
Class II
·Ongoing·Microbiologics Inc·June 12, 2019
Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)
FDA Enforcement
Class III
·Ongoing·Invacare Corporation·July 20, 2022