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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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3 records meeting your search criteria returned- Product Code: GJS Product Problem: Labelling, Instructions for Use or Training Problem Report Date From: 01/1/2009
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ManufacturerBrand NameDate Report Received
ROCHE DIAGNOSTICS GMBH ROCHE COAGUCHEK XS, COAGUCHEK XS PLUS 11/13/2019
ROCHE DIAGNOSTICS GMBH COAGUCHEK XS PRO SYSTEMS 11/13/2019
ROCHE DIAGNOSTICS COAGUCHEK ® XS SYSTEM 08/15/2016
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