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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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9 records meeting your search criteria returned- Product Code: LOZ Product Problem: Material Too Rigid or Stiff Report Date From: 01/1/2009
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ManufacturerBrand NameDate Report Received
SYNCARDIA SYSTEMS, LLC SYNCARDIA 70CC TEMPORARY TOTAL ARTIFICIA 12/04/2020
SYNCARDIA SYSTEMS, LLC SYNCARDIA 70CC TEMPORARY TOTAL ARTIFICIA 09/08/2020
SYNCARDIA SYSTEMS, LLC SYNCARDIA 70CC TEMPORARY TOTAL ARIFICIAL 11/28/2018
SYNCARDIA SYSTEMS, LLC SYNCARDIA 70CC TAH-T 12/04/2017
SYNCARDIA SYSTEMS, LLC SYNCARDIA 70CC TAH-T 09/12/2016
SYNCARDIA SYSTEMS, INC. SYNCARDIA 70CC TAH-T CANNULA 04/08/2016
SYNCARDIA SYSTEMS, INC. SYNCARDIA 70CC TEMPORARY TOTAL ARTIFICIA 02/22/2016
SYNCARDIA SYSTEMS, INC. SYNCARDIA 70CC TAH-T CANNULA 03/12/2015
SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM DRIVER 03/12/2015
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