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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
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

 
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103 records meeting your search criteria returned- Product Code: KDI Product Problem: Device Displays Incorrect Message Report Date From: 01/1/2017
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ManufacturerBrand NameDate Report Received
NXSTAGE MEDICAL, INC. DIALYZER, HIGH PERMEABILITY WITH OR WITH 05/03/2018
BAXTER HEALTHCARE - LUND MONITORS PRISMAFLEX 04/09/2018
BAXTER HEALTHCARE - LUND MONITORS PRISMAFLEX 04/09/2018
GAMBRO AB PRISMAFLEX 04/03/2018
GAMBRO INDUSTRIES PRISMAFLEX MONITOR 03/30/2018
BAXTER HEALTHCARE - MEDOLLA MODENA MONIT PHOENIX 03/23/2018
FRESENIUS MEDICAL CARE NORTH AMERICA OPTIFLUX F160 02/22/2018
GAMBRO DIALYSATOREN GMBH REVACLEAR 02/15/2018
BAXTER HEALTHCARE - LUND MONITORS PRISMAFLEX 12/22/2017
NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE 12/20/2017
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