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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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11 records meeting your search criteria returned- Product Code: OAE Product Problem: Defective Device Report Date From: 01/1/2009
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ManufacturerBrand NameDate Report Received
BOSTON SCIENTIFIC CORPORATION SMARTFREEZE 03/27/2024
BOSTON SCIENTIFIC CORPORATION INTELLANAV STABLEPOINT OPEN-IRRIGATED 03/01/2024
BOSTON SCIENTIFIC CORPORATION INTELLANAV OI 06/22/2023
BOSTON SCIENTIFIC CORPORATION INTELLANAV STABLEPOINT OPEN-IRRIGATED 09/20/2022
BOSTON SCIENTIFIC CORPORATION INTELLANAV STABLEPOINT OPEN-IRRIGATED 06/14/2022
BOSTON SCIENTIFIC CORPORATION INTELLANAV STABLEPOINT OPEN-IRRIGATED 08/18/2021
MEDTRONIC, INC. ARCTIC FRONT ADVANCE PRO 08/13/2020
ST. JUDE MEDICAL, INC. TACTICATH 03/08/2019
MEDTRONIC, INC. ARCTIC FRONT ADVANCE 07/29/2016
ST. JUDE MEDICAL TACTICATH QUARTZ 06/08/2016
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