6 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Power Express, REF B90918
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Biomedical GmbH·September 11, 2024
PE Centrifuge Temperature Controlled, REF: B36366, a component of the Power Express.
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Biomedical GmbH·September 11, 2024
PE Centrifuge, REF: B36365, a component of the Power Express
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Biomedical GmbH·September 11, 2024
DxA 5000; Catalog Number:B50516; UDI:15099590707118 - Product Usage: The DxA 5000 is a high-speed, modular, automated sample handling system that performs pre-analytical and post-analytical sample processing and storage. The automation system also sorts, routes, and presents sample tubes to analyzers for analysis. The DxA 5000 also consolidates a variety of analytical instruments, such as an Immunoassay analyzer, into a unified workstation on a track system.
FDA Enforcement
Class II
·Terminated·Beckman Coulter Biomedical GmbH·September 30, 2020
Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Biomedical GmbH·July 26, 2023
Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Biomedical GmbH·July 26, 2023