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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
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8 records meeting your search criteria returned- Product Code: KDI Product Problem: Use of Incorrect Control/Treatment Settings Report Date From: 01/1/2007
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ManufacturerBrand NameDate Report Received
BAXTER HEALTHCARE CORPORATION PRISMAFLEX MACHINES 08/18/2023
BAXTER HEALTHCARE CORPORATION PRISMAX MACHINES 08/18/2023
BAXTER HEALTHCARE CORPORATION PRISMAX MACHINES 08/17/2023
OUTSET MEDICAL, INC. TABLO HEMODIALYSIS SYSTEM 08/11/2023
SHIBUYA (SBY) SURDIAL X 08/04/2021
BAXTER HEALTHCARE CORPORATION PRISMAX 05/07/2021
CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX 11/28/2017
FRESENIUS MEDICAL CARE NORTH AMERICA 2008T HEMODIALYSIS MACHINE WITH CDX 05/15/2014
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