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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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276 records meeting your search criteria returned- Product Code: HTN Product Problem: Break Report Date From: 01/1/2007
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ManufacturerBrand NameDate Report Received
ACUMED, LLC ACU-SINCH KNOTLESS SYS W/INSRTR 3.5 KIT 09/29/2022
SYNTHES GMBH FIBULINK(R) SYNDESMOSIS REPAIR KIT/SS 09/20/2022
SYNTHES GMBH WASHER 13.0MM 09/16/2022
ACUMED, LLC ACU-SINCH KNOTLESS SYS W/INSRTR 3.5 KIT 09/16/2022
WRIGHTS LANE SYNTHES USA PRODUCTS LLC WASHER 13.0MM 08/29/2022
MONUMENT DEPUY SYNTHES PRODUCTS INC FIBULINK® SYNDESMOSIS REPAIR KIT/SS 08/04/2022
ACUMED, LLC ACU-SINCH KNOTLESS SYS W/INSRTR 3.5 KIT 07/21/2022
ACUMED, LLC ACU-SINCH KNOTLESS SYS W/INSRTR 3.5 KIT 07/21/2022
MONUMENT DEPUY SYNTHES PRODUCTS INC FIBULINK® SYNDESMOSIS REPAIR KIT/SS 07/19/2022
ARTHREX, INC. ACUTE AC REPAIR KIT 07/11/2022
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