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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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5 records meeting your search criteria returned- Product Code: KRA Product Problem: Contamination Report Date From: 01/1/2017
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ManufacturerBrand NameDate Report Received
BOSTON SCIENTIFIC CORPORATION RENEGADE HI-FLO 05/16/2022
BOSTON SCIENTIFIC CORPORATION ANGIOJET ZELANTEDVT 10/04/2021
BOSTON SCIENTIFIC CORPORATION RENEGADE HI-FLO FATHOM SYSTEM 11/05/2020
BOSTON SCIENTIFIC CORPORATION RENEGADE HI-FLO FATHOM SYSTEM 08/26/2020
BOSTON SCIENTIFIC CORPORATION RENEGADE HI-FLO KIT 05/02/2019
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