2 results
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12ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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Olympus Scientific Solutions Americas Corporation (OSSA) VANTA XRF Analyzer. Model Vanta VCR and Vanta VMR Analytical X-ray systems
FDA Recall
Terminated
·Olympus Scientific Solutions Americas·Product code RBY·January 7, 2017
Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an optional accessory of Thoratec HeartMate 3 Left Ventricular Assist System - Product Usage: The HeartMate 3 Coring Tool is intended for use with the HeartMate 3 Left Ventricular Assist System (LVAS). The Coring Tool provides a means to resect a plug of myocardium from the left ventricle, which allows for HeartMate 3 inflow cannula insertion.
FDA Enforcement
Class II
·Terminated·Thoratec Corp.·May 1, 2019