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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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7 records meeting your search criteria returned- Product Code: OTO Product Problem: Defective Device Report Date From: 01/1/2015
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ManufacturerBrand NameDate Report Received
COLOPLAST MANUFACTURING US, LLC. RESTORELLE 04/22/2019
COLOPLAST RESTORELLE L MESH 04/25/2016
COLOPLAST RESTORELLE Y CONTOUR MESH 04/25/2016
BOSTON SCIENTIFIC - MARLBOROUGH UPSYLON¿ 03/17/2016
BOSTON SCIENTIFIC - MARLBOROUGH UPSYLON¿ 03/17/2016
BOSTON SCIENTIFIC BOSTON SCIENTIFIC 01/28/2016
BOSTON SCIENTIFIC BOSTON SCIENTIFIC 01/27/2016
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