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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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53 records meeting your search criteria returned- Product Code: GJS Product Problem: Adverse Event Without Identified Device or Use Problem Report Date From: 01/1/2015
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ManufacturerBrand NameDate Report Received
ROCHE DIAGNOSTICS COAGUCHEK ® XS SYSTEM 08/28/2019
ROCHE DIAGNOSTICS COAGUCHEK ® XS SYSTEM 03/08/2019
ALERE SAN DIEGO, INC INRATIO PT/INR TEST STRIPS 12/04/2018
ROCHE DIAGNOSTICS COAGUCHEK ® XS SYSTEM 10/10/2018
ALERE SAN DIEGO, INC INRATIO PT/INR TEST STRIPS 09/28/2018
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS DADE INNOVIN 09/07/2018
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS DADE INNOVIN 06/22/2018
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS DADE INNOVIN 05/18/2018
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS DADE INNOVIN 04/26/2018
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS DADE INNOVIN 02/07/2018
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