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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: Unsealed Device Packaging 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 ANGIOJET SOLENT OMNI 09/02/2021
COOK INC CXI SUPPORT CATHETER 04/01/2021
BOSTON SCIENTIFIC CORPORATION ANGIOJET ZELANTEDVT 12/13/2019
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