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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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9 records meeting your search criteria returned- Product Code: GCA Product Problem: Material Fragmentation Report Date From: 01/1/2015
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ManufacturerBrand NameDate Report Received
COOK ENDOSCOPY FUSION QUATTRO EXTRACTION BALLOON 09/05/2019
COOK ENDOSCOPY FUSION EXTRACTION BALLOON WITH MULTIPLE 07/02/2019
COOK ENDOSCOPY FUSION QUATTRO EXTRACTION BALLOON 03/04/2019
COOK ENDOSCOPY FUSION QUATTRO EXTRACTION BALLOON 03/04/2019
COOK ENDOSCOPY TRI-EX EXTRACTION BALLOON WITH MULTIPLE 07/23/2018
COOK ENDOSCOPY FUSION EXTRACTION BALLOON WITH MULTIPLE 07/10/2018
COOK ENDOSCOPY FUSION QUATTRO EXTRACTION BALLOON 03/16/2018
COOK INC ULTRATHANE MAC-LOC LOCKING LOOP BILIARY 02/06/2018
COOK ENDOSCOPY FUSION EXTRACTION BALLOON WITH MULTIPLE 06/29/2016
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