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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
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15 records meeting your search criteria returned- Product Code: GJS Product Problem: Device Operates Differently Than Expected Report Date From: 01/1/2007
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ManufacturerBrand NameDate Report Received
ROCHE COAGUCHECK INR MONITOR 03/05/2018
ROCHE ROCHE 02/15/2018
SIEMENS HEALTHCARE DIAGNOSTICS XPRECIA STRIDE COAGULATION SYSTEM 12/01/2016
ROCHE DIAGNOSTICS COAGUCHEK XS PLUS KIT USA 02/08/2016
ALERE ALERE INRATIO PT/INR MONITOR SYSTEM 04/15/2015
ALERE ALERE INRATIO PT/INR MONITORING SYSTEM 01/14/2015
ALERE SAN DIEGO, INC. ALERE INRATIO PT/INR MONITORING SYSTEM 12/17/2014
ALERE SAN DIEGO, INC. KIT, TRIAGE, CARDIAC TNI 11/18/2014
ALERE SAN DIEGO, INC. INRATIO PT/INR TEST STRIPS 07/10/2014
ALERE ALERE TEST STRIPS 05/19/2014
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