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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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402 records meeting your search criteria returned- Product Code: KDI Product Problem: Leak/Splash Report Date From: 01/1/2017
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ManufacturerBrand NameDate Report Received
OUTSET MEDICAL, INC. TABLO HEMODIALYSIS SYSTEM 04/29/2022
BAXTER HEALTHCARE CORPORATION PRISMAFLEX SETS TPE 04/07/2022
BAXTER HEALTHCARE CORPORATION PRISMAFLEX SETS (ST) 03/16/2022
BAXTER HEALTHCARE CORPORATION REVACLEAR 300 DIALYZER 03/10/2022
BAXTER HEALTHCARE CORPORATION PRISMAFLEX SETS (HF) 02/28/2022
BELLCO SRL CLEARUM HS 02/03/2022
BAXTER HEALTHCARE CORPORATION PRISMAFLEX M100 FILTER 01/11/2022
BAXTER HEALTHCARE CORPORATION AK 96 01/11/2022
NXSTAGE MEDICAL, INC. NXSTAGE CARTRIDGE EXPRESS 12/23/2021
BAXTER HEALTHCARE CORPORATION PRISMAFLEX M150 12/21/2021
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