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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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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
OUTSET MEDICAL, INC. TABLO HEMODIALYSIS SYSTEM 04/29/2022
OUTSET MEDICAL, INC. TABLO(R) HEMODIALYSIS SYSTEM 04/05/2022
BAXTER HEALTHCARE CORPORATION PRISMAFLEX 02/18/2022
OUTSET MEDICAL, INC. TABLO(R) HEMODIALYSIS SYSTEM 12/21/2021
NXSTAGE MEDICAL, INC. NXSTAGE 11/24/2021
NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE 10/11/2021
GAMBRO INDUSTRIES PRISMAFLEX 05/05/2021
NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE 04/30/2021
CHF SOLUTIONS INC. AQUADEX SMARTFLOW CONSOLE 04/29/2021
CHF SOLUTIONS, INC. AQUADEX SMARTFLOW CONSOLE 04/16/2021
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