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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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52 records meeting your search criteria returned- Product Code: HRX Product Problem: Peeled/Delaminated Report Date From: 01/1/2016
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ManufacturerBrand NameDate Report Received
DEPUY MITEK LLC US BARREL BURR 4.0MM 5PK 12/10/2019
DEPUY MITEK LLC US AGGRESSIVE 4.0MM 5PK 11/20/2019
DEPUY MITEK LLC US AGGRESSIVE 4.0MM 5PK 11/20/2019
DEPUY MITEK LLC US AGGRESSIVE 4.0MM 5PK 11/19/2019
DEPUY MITEK LLC US ULTRA AGGRESSIVE PLUS 5.0 5PK 11/18/2019
DEPUY MITEK LLC US FULL RADIUS 4.0MM 5PK 09/30/2019
DEPUY MITEK LLC US ULTRA AGGRESSIVE PLUS 4.0MM 5PK 09/23/2019
DEPUY MITEK LLC US ULTRA AGGRESSIVE PLUS 4.0MM 5PK 09/23/2019
DEPUY MITEK LLC US ULTRA AGGRESSIVE PLUS 5.0 5PK 08/05/2019
DEPUY MITEK LLC US OMNICUT 4.2 RES BLADE 5PK DUO+ 07/22/2019
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