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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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6 records meeting your search criteria returned- Product Code: OTO Product Problem: Device Appears to Trigger Rejection Report Date From: 01/1/2015
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ManufacturerBrand NameDate Report Received
C.R. BARD, INC. (COVINGTON) -1018233 ALYTE Y-MESH GRAFT 06/26/2020
Unknown Manufacturer RESTORELLE Y 06/19/2020
COLOPLAST CORP RESTORELLE - UNKNOWN 03/06/2020
Unknown Manufacturer SURGICAL MESH 01/31/2020
COLOPLAST A/S RESTORELLE 11/27/2019
COLOPLAST CORP RESTORELLE FLAT MESH 08/29/2019
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