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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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15 records meeting your search criteria returned- Product Code: GHH Report Date From: 1/1/2015 Report Date To: 12/31/2015
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ManufacturerBrand NameDate Report Received
BBI SOLUTIONS OEM LTD CLEARVIEW SIMPLIFY D-DIMER 12/02/2015
ROCHE DIAGNOSTICS TINA-QUANT D-DIMER 10/14/2015
ALERE SAN DIEGO, INC. TRIAGE D-DIMER PANEL 10/05/2015
ROCHE DIAGNOSTICS TINA-QUANT D-DIMER 09/22/2015
ROCHE DIAGNOSTICS ROCHE CARDIAC D-DIMER 09/02/2015
ROCHE DIAGNOSTICS ROCHE CARDIAC D-DIMER 08/28/2015
ROCHE DIAGNOSTICS ROCHE CARDIAC D-DIMER 08/13/2015
ALERE SAN DIEGO, INC. TRIAGE D-DIMER PANEL 07/28/2015
ROCHE DIAGNOSTICS ROCHE CARDIAC D-DIMER 07/23/2015
ROCHE DIAGNOSTICS ROCHE CARDIAC D-DIMER 07/01/2015
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