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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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10 records meeting your search criteria returned- Product Code: LOZ Product Problem: Failure of Device to Self-Test Report Date From: 01/1/2007
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ManufacturerBrand NameDate Report Received
SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION 2 DRIVER 04/23/2018
SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION 2 DRIVER 01/05/2018
SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM DRIVER 12/05/2017
SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM DRIVER 12/05/2017
SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION 2 DRIVER 10/09/2017
SYNCARDIA SYSTEMS, INC. SYNCARDIA COMPANION EXTERNAL LI-BATTERY 05/08/2015
SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM DRIVER 04/01/2015
SYNCARDIA SYSTEMS, INC. SYNCARDIA COMPANION 2 DRIVER 03/20/2015
SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM DRIVER 01/15/2015
SYNCARDIA SYSTEMS, INC. SYNDARDIA COMPANION 2 DRIVER 12/05/2014
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