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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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111 records meeting your search criteria returned- Product Code: KDI Patient Problem: Insufficient Information Report Date From: 01/1/2017
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ManufacturerBrand NameDate Report Received
BAXTER HEALTHCARE CORPORATION PRISMAX 03/05/2021
BAXTER HEALTHCARE CORPORATION PRISMAX 03/03/2021
CONCORD MANUFACTURING 2008T HD SYS. CDX W/BIBAG BLUE STAR 02/26/2021
NXSTAGE MEDICAL, INC. SYSTEM ONE S 02/26/2021
BAXTER HEALTHCARE CORPORATION PRISMAX SYSTEM 02/03/2021
FRESENIUS USA MANUFACTURING, INC. FRESENIUS 160NR OPTIFLUX DIALYZERS 01/29/2021
FRESENIUS USA MANUFACTURING, INC. FRESENIUS 160NR OPTIFLUX DIALYZERS 01/29/2021
FRESENIUS USA MANUFACTURING, INC. FRESENIUS 160NR OPTIFLUX DIALYZERS 01/29/2021
NIKKISO CO.,LTD DBB-06 HEMODIALYSIS DELIVERY SYSTEM 12/25/2020
NIKKISO CO.,LTD DBB-06 HEMODIALYSIS DELIVERY SYSTEM 12/25/2020
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