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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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26 records meeting your search criteria returned- Product Code: KDI Product Problem: Therapeutic or Diagnostic Output Failure Report Date From: 01/1/2017
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ManufacturerBrand NameDate Report Received
BAXTER HEALTHCARE CORPORATION REVACLEAR 300 04/09/2021
NXSTAGE MEDICAL, INC. NXSTAGE 03/30/2021
BAXTER HEALTHCARE CORPORATION PRISMAXPRISMAX SYSTEM 03/09/2021
NIKKISO CO.,LTD DBB-06 HEMODIALYSIS DELIVERY SYSTEM 12/10/2020
FRESENIUS USA, INC. 2008 SERIES HEMODIALYSIS MACHINES 11/17/2020
BAXTER HEALTHCARE CORPORATION PRISMAXPRISMAX SYSTEM 10/20/2020
BAXTER HEALTHCARE CORPORATION PRISMAXPRISMAX SYSTEM 10/14/2020
NXSTAGE MEDICAL, INC. SYSTEM ONE S 08/03/2020
GAMBRO DASCO SPA PHOENIX 06/19/2020
GAMBRO AB PRISMAFLEX 05/01/2020
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