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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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6 records meeting your search criteria returned- Product Code: GJS Product Problem: Defective Device Report Date From: 01/1/2009
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ManufacturerBrand NameDate Report Received
ROCHE DIAGNOSTIC OPERATIONS INC COAGUCHEK TEST STRIPS 11/23/2018
ROCHE DIAGNOSTICS OPERATIONS, INC. COAGUCHEK XS 11/20/2018
ROCHE DIAGNOSTICS GMBH COAGUCHEK XS PT TEST 11/19/2018
ALERE ALERE 01/29/2015
ALERE ALERE TEST STRIPS 05/19/2014
HEMOSENSE INC INRATIO 03/27/2014
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