2 results
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9ms
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Sources: EU EUDAMED, US FDA
ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number: 11327600
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·June 10, 2020
PrepIT Q2A Kit, Model PT-Q2A-96 containing component reagent AG (PT-QAG-96) 1.4mL and ST (PT-QST-96) 2.9mL - Product Usage: used for the removal of SDS and other inhibitors from samples collected using DNA Genotek oral sample collection kits.
FDA Enforcement
Class III
·Terminated·DNA Genotek Inc.·September 30, 2020