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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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87 records meeting your search criteria returned- Product Code: KDI Product Problem: Improper or Incorrect Procedure or Method 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 PRISMAX MACHINES 04/04/2022
BAXTER HEALTHCARE CORPORATION PRISMAFLEX M100 01/05/2022
BAXTER HEALTHCARE CORPORATION PRISMAX 12/29/2021
BAXTER HEALTHCARE CORPORATION AK 98 12/28/2021
Unknown Manufacturer KIDNEY DIALYSIS 10/29/2021
NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE 10/27/2021
BAXTER HEALTHCARE CORPORATION AK 96 10/21/2021
BAXTER HEALTHCARE CORPORATION NI 08/18/2021
BAXTER HEALTHCARE CORPORATION PRISMAFLEX SEPXIRIS150 08/05/2021
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