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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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8 records meeting your search criteria returned- Product Code: LOZ Product Problem: Self-Activation or Keying Report Date From: 01/1/2009
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ManufacturerBrand NameDate Report Received
SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION 2 DRIVER 05/11/2018
SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION 2 DRIVER 12/08/2017
SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM ONBOARD BATTERY 12/07/2016
SYNCARDIA SYSTEMS, INC. SYNCARDIA COMPANION 2 DRIVER 05/26/2016
SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM DRIVER 09/17/2015
SYNCARDIA SYSTEMS, INC. SYNCARDIA COMPANION 2 DRIVER 10/20/2014
SYNCARDIA SYSTEMS, INC. SYNCARDIA COMPANION 2 DRIVER 02/26/2014
SYNCARDIA SYSTEMS, INC. SYNCARDIA COMPANION 2 DRIVER 01/31/2014
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