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U.S. Department of Health and Human Services

MAUDE - Manufacturer and User Facility Device Experience

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510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
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17 records meeting your search criteria returned- Product Code: MLV Product Problem: Fracture Report Date From: 01/1/2009
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ManufacturerBrand NameDate Report Received
W. L. GORE & ASSOCIATES, INC. GORE® CARDIOFORM ASD OCCLUDER 12/15/2023
ABBOTT MEDICAL AMPLATZER SEPTAL OCCLUDER 11/13/2023
W. L. GORE & ASSOCIATES, INC. GORE® CARDIOFORM ASD OCCLUDER 08/02/2023
ABBOTT MEDICAL AMPLATZER TALISMAN PFO OCCLUDER 06/13/2023
W. L. GORE & ASSOCIATES, INC. GORE® CARDIOFORM ASD OCCLUDER 04/12/2023
W. L. GORE & ASSOCIATES, INC. GORE® CARDIOFORM SEPTAL OCCLUDER 03/08/2022
W. L. GORE & ASSOCIATES, INC. GORE® CARDIOFORM ASD OCCLUDER 11/15/2021
W. L. GORE & ASSOCIATES, INC. GORE CARDIOFORM SEPTAL OCCLUDER 05/05/2021
AGA MEDICAL CORPORATION AMPLATZER AMULET 07/13/2020
W.L. GORE & ASSOCIATES GORE HELEX SEPTAL OCCLUDER 12/03/2019
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