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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
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

 
 
9 records meeting your search criteria returned- Product Code: GJS Product Problem: Thermal Decomposition of Device Report Date From: 01/1/2007
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ManufacturerBrand NameDate Report Received
ROCHE DIAGNOSTICS COAGUCHEK ® XS SYSTEM 03/20/2020
ROCHE DIAGNOSTICS COAGUCHEK ® XS SYSTEM 06/15/2018
ROCHE DIAGNOSTICS COAGUCHEK ® XS SYSTEM 06/12/2018
ROCHE DIAGNOSTICS COAGUCHEK ® XS SYSTEM 01/02/2018
ROCHE DIAGNOSTICS COAGUCHEK XS PRO HANDHELD BASIC MODULE 08/22/2016
ROCHE DIAGNOSTICS COAGUCHEK XS PRO KIT 08/22/2016
ROCHE DIAGNOSTICS COAGUCHEK ® XS SYSTEM 11/24/2015
ROCHE DIAGNOSTICS COAGUCHEK ® XS PLUS SYSTEM 03/16/2015
ROCHE DIAGNOSTICS COAGUCHEK ® XS SYSTEM 02/10/2014
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