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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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28 records meeting your search criteria returned- Product Code: KDI Product Problem: Improper Flow or Infusion Report Date From: 01/1/2017
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ManufacturerBrand NameDate Report Received
OUTSET MEDICAL, INC. TABLO(R) HEMODIALYSIS SYSTEM 04/05/2022
BAXTER HEALTHCARE CORPORATION PRISMAX 02/14/2022
BAXTER HEALTHCARE CORPORATION PRISMAX 02/07/2022
OUTSET MEDICAL INC. OUTSET MEDICAL TABLO 11/26/2021
BAXTER HEALTHCARE CORPORATION AK 98 11/15/2021
BAXTER HEALTHCARE CORPORATION PRISMAX 11/15/2021
BAXTER HEALTHCARE CORPORATION PRISMAX 11/11/2021
BAXTER HEALTHCARE CORPORATION GAMBRO PHOENIX 07/22/2021
GAMBRO INDUSTRIES PRISMAFLEX 05/05/2021
BAXTER HEALTHCARE CORPORATION PRISMAFLEX ST150 04/19/2021
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