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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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45 records meeting your search criteria returned- Product Code: KDI Product Problem: Device Alarm System Report Date From: 01/1/2017
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ManufacturerBrand NameDate Report Received
BAXTER HEALTHCARE - MEYZIEU PRISMAFLEX HF1400 05/14/2020
NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE 04/03/2020
NXSTAGE MEDICAL, INC DIALYZER, HIGH PERMEABILITY WITH OR WITH 03/31/2020
NXSTAGE MEDICAL, INC. DIALYZER, HIGH PERMEABILITY WITH OR WITH 03/20/2020
GAMBRO AB PRISMAFLEX 03/18/2020
GAMBRO LUNDIA AB PRISMAFLEX 12/05/2019
NIPRO CORPORATION (ODATE) NIPRO CELLENTIA DIALYZER 08/14/2019
NIPRO CORPORATION (ODATE) NIPRO CELLENTIA DIALYZER 07/19/2019
NXSTAGE MEDICAL, INC. NXSTAGE CARTRIDGE EXPRESS 07/08/2019
NXSTAGE MEDICAL, INC. NXSTAGE MEDICAL PEDIATRIC MEDICAL, INC. 06/25/2019
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