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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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30 records meeting your search criteria returned- Product Code: KDI Product Problem: No Audible Alarm Report Date From: 01/1/2007
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ManufacturerBrand NameDate Report Received
BAXTER HEALTHCARE CORPORATION PRISMAFLEX 02/04/2020
BAXTER HEALTHCARE CORPORATION PRISMAFLEX 01/29/2020
BAXTER HEALTHCARE CORPORATION PRISMAFLEX 01/28/2020
BAXTER HEALTHCARE CORPORATION PRISMAFLEX 12/03/2019
NXSTAGE MEDICAL, INC. NXSTAGE CRRT 01/03/2019
CONCORD MANUFACTURING 2008T HEMODIALYSIS SYSTEM W/BIBAG 02/05/2018
CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX 11/22/2017
FRESENIUS 2008T 2008T 06/03/2016
FRESENIUS MEDICAL CARE NORTH AMERICA 2008T HEMODIALYSIS SYS., WITH CDX 09/02/2015
FRESENIUS MEDICAL CARE NORTH AMERICA U2008T HEMODIALYSIS SYS. WITH CDX AS OPT 07/24/2014
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