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U.S. Department of Health and Human Services

MAUDE - Manufacturer and User Facility Device Experience

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12 records meeting your search criteria returned- Product Code: LOX Product Problem: Material Fragmentation Report Date From: 01/1/2016
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ManufacturerBrand NameDate Report Received
ABBOTT VASCULAR ABBOTT VASCULAR 3.0X12 NCTREK RX BALLOON 05/28/2021
KANEKA CORPORATION KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZER 12/21/2020
KANEKA CORPORATION KANEKA PTCA CATHETER CO-R8 (TASUKI) 12/13/2020
KANEKA CORPORATION KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZER 09/30/2020
MEDTRONIC IRELAND MEDTRONIC EUPHORA BALLOON RX 3.00MM X 15 08/06/2020
BOSTON SCIENTIFIC CORPORATION NC EMERGE 07/01/2020
ABBOTT VASCULAR ABBOTT VASCULAR 11/18/2019
MEDTRONIC, INC. 1.25MM X 15MM SPRINTER LEGEND, OTW 08/24/2018
ABBOTT VASCULAR ABBOTT VASCULAR TREK BALLOON DILATATION 07/24/2018
KANEKA CORPORATION KANEKA PTCA CATHETER CO-R6 (RAIDEN3) 03/12/2018
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