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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 10 of 11 Results
510(K) Number: K050438
 
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Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958. 2 06/26/2017 Medtronic Navigation, Inc.
MACH Cranial Treon. The software application is sent in CD format with an IFU, wrapped in plastic wi... 2 08/02/2016 Medtronic Navigation, Inc.
Synergy Cranial S7. The software application is sent in CD format with an IFU, wrapped in plastic wi... 2 08/02/2016 Medtronic Navigation, Inc.
P/N: 9734856, SCREWDRIVER, 9734856, SOLERA STD MAST; P/N: 9734857, SCREWDRIVER, 9734857, SOLERA RDN ... 2 09/30/2015 Medtronic Navigation, Inc.
The Vertex Max Drill Tube is a component within the Navigated Vertex Max Drill Guide Set (item 97333... 2 11/29/2012 Medtronic Navigation, Inc.
DICOM Query/Retrieve, version 1.1.4. Individual part # 9733808, or as part of a system order, DICOM ... 2 07/11/2011 Medtronic Navigation, Inc.
Polaris Spectra Position Sensor Unit, a component of the StealthStation S7 System, Medtronic Navigat... 2 03/04/2011 Medtronic Navigation, Inc
Vertex Max Drill Tube, Catalog Number 9733140, a component of the Navigated Vertex Max Drill Guide K... 2 02/04/2011 Medtronic Navigation, Inc
Polaris Spectra System Control Unit, a component of the StealthStation S7 System. Medtronic Navigati... 2 12/17/2010 Medtronic Navigation, Inc
Vertex Max Drill Guide, Catalog Number 9732355, to be used with a Medtronic Computer-Assisted Surger... 2 10/26/2010 Medtronic Navigation, Inc
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