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U.S. Department of Health and Human Services

MAUDE - Manufacturer and User Facility Device Experience

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Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
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7 records meeting your search criteria returned- Product Code: LOZ Product Problem: Material Rupture Report Date From: 01/1/2007
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ManufacturerBrand NameDate Report Received
SYNCARDIA SYSTEMS, LLC SYNCARDIA 70CC TAH-T 11/01/2016
SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM ONBOARD BATTERY 10/07/2016
SYNCARDIA SYSTEMS, LLC SYNCARDIA 70CC TAH-T 04/14/2016
SYNCARDIA SYSTEMS, INC. SYNCARDIA 70CC TAH-T CANNULA 04/08/2016
SYNCARDIA SYSTEMS, INC. SYNCARDIA 70CC TAH-T CANNULA 04/04/2016
SYNCARDIA SYSTEMS, LLC SYNCARDIA 70CC TEMPORARY TOTAL ARTIFICIA 02/24/2016
SYNCARDIA SYSTEMS, INC. SYNCARDIA 70CC TAH-T CANNULA 10/09/2015
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