3 results
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20ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Cobas 8000 Modular Analyzer Series, Model/Catalog/Part Number: 05641489001. The Cobas 8000 is a fully automated system for clinical chemistry analysis.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·December 12, 2012
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025