4 results
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19ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Various neurology packs
FDA Enforcement
Class II
·Ongoing·American Contract Systems, Inc.·September 14, 2022
Various convenience packs
FDA Enforcement
Class II
·Ongoing·American Contract Systems, Inc.·September 14, 2022
Various Angiography/Cath Lab packs/trays
FDA Enforcement
Class II
·Ongoing·American Contract Systems, Inc.·September 14, 2022
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012