2 results
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20ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·February 18, 2015
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·February 26, 2020