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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: LIT Product Problem: Material Fragmentation Report Date From: 01/1/2017
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ManufacturerBrand NameDate Report Received
KANEKA CORPORATION CROSPERIO RX 03/30/2022
KANEKA CORPORATION SHIDEN 01/06/2022
KANEKA CORPORATION SENRI 12/21/2021
MEDTRONIC / COVIDIEN LLC COVIDIEN EV3 RAPID CROSS 2.50-2.00MM X 2 12/16/2021
KANEKA CORPORATION SHIDEN 09/02/2021
MEDTRONIC MEXICO ADMIRAL XTREME OTW 05/23/2018
CLEARSTREAM TECHNOLOGIES LTD. SLEEK RX 10/17/2017
MEDTRONIC MEXICO PACIFIC XTREME 07/12/2017
CLEARSTREAM TECHNOLOGIES LTD. SLEEK RX 06/14/2017
ABBOTT VASCULAR INC. ARMADA 04/25/2017
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