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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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12 records meeting your search criteria returned- Product Code: KDI Product Problem: Use of Device Problem Report Date From: 01/1/2017
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ManufacturerBrand NameDate Report Received
OUTSET MEDICAL, INC. TABLO X HEMODIALYSIS SYSTEM 04/22/2022
SHIBUYA (SBY) SURDIAL X 08/04/2021
NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE 10/22/2020
B. BRAUN AVITUM AG DAILOG DAILYSIS MACHINE 08/24/2020
OUTSET MEDICAL, INC. TABLO HEMODIALYSIS SYSTEM 06/11/2019
OGDEN MANUFACTURING PLANT OPTIFLUX 160NRE DIALYZER FINISHED ASSY. 06/12/2018
B. BRAUN AVITUM AG - MELSUNGEN DIALOG+®  10/27/2017
NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE 09/13/2017
GAMBRO LUNDIA AB PRISMAFLEX 06/29/2017
GAMBRO LUNDIA AB PRISMAFLEX 03/31/2017
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