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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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14 records meeting your search criteria returned- Product Code: KDI Product Problem: Defective Device Report Date From: 01/1/2017
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ManufacturerBrand NameDate Report Received
GAMBRO DASCO SPA PHOENIX 04/18/2022
BAXTER HEALTHCARE CORPORATION THERMAXTHERMAX BLOOD WARMER 01/06/2022
NXSTAGE MEDICAL, INC. NXSTAGE CARTRIDGE EXPRESS 12/23/2021
GAMBRO INDUSTRIES PRISMAFLEX SET 09/08/2021
NXSTAGE MEDICAL, INC. NXSTAGE CARTRIDGE EXPRESS 08/31/2021
NXSTAGE MEDICAL, INC. NXSTAGE 03/15/2021
BAXTER HEALTHCARE CORPORATION PRISMAX CRRT MACHINE/BAXTER 12/04/2020
BAXTER HEALTHCARE CORPORATION PRISMAX CRRT MACHINE/BAXTER 12/04/2020
FRESENIUS USA, INC. FRESENIUS 2008T BLUESTAR BIGBAG DIALYSIS 10/20/2020
BAXTER HEALTHCARE CORPORATION PRISMAXPRISMAX SYSTEM 10/20/2020
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