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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 10 of 500 Results *
Date Classified to: 07/04/2014 510(K) Number: K101558
 
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Product Description
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Lotus TAVR 25mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Sterile Ma... 1 Jan-13-2015 Boston Scientific Corporation
Lotus TAVR 23mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Sterile Ma... 1 Jan-13-2015 Boston Scientific Corporation
Lotus TAVR 27mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Sterile Ma... 1 Jan-13-2015 Boston Scientific Corporation
INRatio Monitors - 0100004 Alere INRatio PT/INR System Professional - 0100007 INRatio Prothrombin ... 1 Jan-03-2015 Alere San Diego, Inc.
Alere INRatio PT/INR Test Strips, Alere INRatio PT/INR System Professional - 0100071 Alere INRatio... 1 Jan-03-2015 Alere San Diego, Inc.
INRatio 2 Monitors - 0200431 Alere INRatio 2 PT/INR Professional Testing System - 0200432 Alere IN... 1 Jan-03-2015 Alere San Diego, Inc.
ADULT Radiotranslucent Electrode, Part number T100LO-PHILIPS, Rx ONLY, For use with Philips HeartSta... 1 Dec-24-2014 Heart Sync, Inc.
ADULT/CHILD Radiotransparent Electrode, Part number C100AC-PHILIPS, Rx ONLY, For use with Philips He... 1 Dec-24-2014 Heart Sync, Inc.
ADULT Radiotransparent Electrode, Part number C100-PHILIPS, Rx ONLY, For use with Philips HeartStart... 1 Dec-24-2014 Heart Sync, Inc.
ADULT/CHILD Radiotranslucent Electrode, Part number T100AC-PHILIPS, Rx ONLY, For use with Philips He... 1 Dec-24-2014 Heart Sync, Inc.

*   The maximium 500 devices meeting your search criteria returned. Please narrow your search.
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