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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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16 records meeting your search criteria returned- Product Code: FDI Product Problem: Material Split, Cut or Torn Report Date From: 01/1/2019
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ManufacturerBrand NameDate Report Received
BOSTON SCIENTIFIC CORPORATION ULTRATOME XL 11/28/2023
BOSTON SCIENTIFIC CORPORATION ULTRATOME XL 09/19/2023
BOSTON SCIENTIFIC CORPORATION ULTRATOME XL 01/31/2023
BOSTON SCIENTIFIC CORPORATION RESCUENET 01/30/2023
BOSTON SCIENTIFIC CORPORATION CAPTIVATOR 11/22/2022
BOSTON SCIENTIFIC CORPORATION CAPTIVATOR II 07/27/2022
BOSTON SCIENTIFIC CORPORATION CAPTIVATOR 05/19/2022
BOSTON SCIENTIFIC CORPORATION CAPTIVATOR 05/10/2022
BOSTON SCIENTIFIC CORPORATION RESCUENET 03/30/2022
BOSTON SCIENTIFIC CORPORATION ULTRATOME XL 12/15/2021
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