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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
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

 
 
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19 records meeting your search criteria returned- Product Code: HWC Product Problem: Material Split, Cut or Torn Report Date From: 01/1/2015
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ManufacturerBrand NameDate Report Received
DEPUY MITEK LLC US MINI QA+ #2/0 ETH V-5 *EA 09/25/2019
DEPUY MITEK LLC US 4.5 HEALIX TI ANCHOR W/OCORD 09/24/2019
DEPUY MITEK LLC US 5.5 HEALIX ADVANCE PEEK W/OC&ND 09/24/2019
DEPUY MITEK LLC US 5.5 HEALIX TI ANCHR W/OC +NDLS 07/08/2019
DEPUY MITEK LLC US 5.5 HEALIX ADVANCE PEEK W/OC 06/26/2019
DEPUY MITEK LLC US FASTIN RC 5MM OCORD W/O NDLS 06/26/2019
WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM CANNULATED SCREW PARTIALLY THREADE 06/21/2019
DEPUY MITEK LLC US 5.5 HEALIX ADVANCE PEEK W/OC 06/03/2019
DEPUY MITEK LLC US 5.5 HEALIX ADVANCE PEEK W/OC 06/03/2019
DEPUY MITEK LLC US 5.5 HEALIX ADVANCE PEEK W/OC 06/03/2019
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