3 results
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11ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Bivona Aire-Cuf Endotracheal Tube
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·November 3, 2021
Medtronic Custom Packs and Total System Packs. Pack can contain a number of different components specified by the customer and individualized for their bypass circuit set up requirements. Intersept Custom Tubing Pack, Sterile and nonpyrogenic Fluid Path: Do not use if package is opened or damaged. For Single Use Only. Manufacturer: Medtronic , Inc. Minneapolis, MN 55432-5604 USA
FDA Recall
Terminated
·Medtronic Perfusion Systems·Product code DWE·March 25, 2005
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014