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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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10 records meeting your search criteria returned- Product Code: KDI Product Problem: Defective Alarm Report Date From: 01/1/2018
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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
OUTSET MEDICAL, INC. TABLO(R) HEMODIALYSIS SYSTEM 04/04/2022
GAMBRO DASCO S.P.A., MONITORS DIVISION PHOENIX 02/24/2022
BAXTER HEALTHCARE CORPORATION PRISMAFLEX 12/20/2021
NXSTAGE MEDICAL, INC. NXSTAGE CARTRIDGE EXPRESS 06/28/2021
CHF SOLUTIONS, INC. AQUADEX FLEXFLOW SYSTEM 10/17/2018
CHF SOLUTIONS, INC. AQUADEX FLEXFLOW SYSTEM 10/17/2018
B. BRAUN AVITUM AG - MELSUNGEN DIALOG+®  03/01/2018
B. BRAUN AVITUM AG - MELSUNGEN DIALOG+®  01/24/2018
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