2 results
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18ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbished (386220); (3) Access 2 Immunoassay Analyzer, Refurbished (A65531) ; and (4) Access 2 Section, DxC 600i Packaged(A25640).
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·March 22, 2023