2 results
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6ms
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Sources: EU EUDAMED, US FDA
TECNIS Toric 1-Piece IOL, Model Number: ZCT150 +23.5D SE 1.50D CYL - Product Usage: intended to be placed in the capsular bag.
FDA Enforcement
Class II
·Terminated·Johnson & Johnson Surgical Vision Inc·March 10, 2021
Cortisol Saliva Luminescence Immunoassay The IBL International Cortisol Saliva Luminescence immunoassay is intended for the in-vitro diagnostic quantitative determination of Cortisol in human saliva and for use as an aid in the diagnosis and treatment of adrenal disorders. The device is not intended for point-of-care settings.
FDA Enforcement
Class II
·Terminated·Tecan US, Inc.·September 5, 2018