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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
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37 records meeting your search criteria returned- Product Code: OZT Product Problem: Adverse Event Without Identified Device or Use Problem Report Date From: 01/1/2019
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ManufacturerBrand NameDate Report Received
EDWARDS LIFESCIENCES EDWARDS TRANSFEMORAL BALLOON CATHETER 03/31/2024
EDWARDS LIFESCIENCES LLC EDWARDS TRANSFEMORAL BALLOON CATHETER 02/16/2024
EDWARDS LIFESCIENCES EDWARDS TRANSFEMORAL BALLOON CATHETER 01/05/2024
EDWARDS LIFESCIENCES EDWARDS TRANSFEMORAL BALLOON CATHETER 11/13/2023
EDWARDS LIFESCIENCES EDWARDS TF BAV CATHETER 08/25/2023
EDWARDS LIFESCIENCES ASCENDRA BAVC 08/15/2023
LOMA VISTA LOMA VISTA BALLOON 08/12/2023
NUMED, INC. NUCLEUS AORTIC 20 MM 08/12/2023
EDWARDS LIFESCIENCES EDWARDS TRANSFEMORAL BALLOON CATHETER 06/09/2023
EDWARDS LIFESCIENCES EDWARDS TRANSFEMORAL BALLOON CATHETER 01/27/2023
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