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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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5 records meeting your search criteria returned- Product Code: LOZ Product Problem: Application Interface Becomes Non-Functional Or Program Exits Abnormally Report Date From: 01/1/2009
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ManufacturerBrand NameDate Report Received
SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION 2 DRIVER 09/08/2017
SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION 2 DRIVER 06/27/2017
SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION HOSPITAL CART 02/13/2017
SYNCARDIA SYSTEMS, INC. SYNCARDIA COMPANION 2 DRIVER 05/05/2015
SYNCARDIA SYSTEMS, INC. SYNCARDIA CSS CONSOLE MONITOR 04/15/2015
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