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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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99 records meeting your search criteria returned- Product Code: HWE Product Problem: Adverse Event Without Identified Device or Use Problem Report Date From: 01/1/2009
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ManufacturerBrand NameDate Report Received
TORNIER S.A.S. PERFORM ALIGNMENT PIN SMOOTH SINGLE USE 03/14/2024
TREACE MEDICAL CONCEPTS, INC 3.5MM TRANSVERSE SCREWS 10/05/2023
SMITH & NEPHEW, INC. UNKNOWN JOINT REPAIR DEVICE 07/12/2023
SMITH & NEPHEW, INC. UNKNOWN ARTHROSCOPY & TECHNOLOGY DEVICE 07/12/2023
TORNIER INC UNKNOWN_WRIGHT TORNIER-BLOOMINGTON_PRODU 05/26/2023
STRYKER INSTRUMENTS-A DIVISION OF STRYKE SYSTEM 8 SABO SAGITTAL SAW 02/14/2023
TREACE MEDICAL CONCEPTS, INC. 1.6MM K-WIRE X 6IN LNG 12/03/2022
STRYKER INSTRUMENTS-A DIVISION OF STRYKE STERNUM BLADE GUARD 09/22/2022
STRYKER INSTRUMENTS-A DIVISION OF STRYKE STERNUM BLADE GUARD 09/07/2022
STRYKER INSTRUMENTS-A DIVISION OF STRYKE STERNUM BLADE GUARD 09/01/2022
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