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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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6 records meeting your search criteria returned- Product Code: GKZ Product Problem: High Readings Report Date From: 01/1/2009
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ManufacturerBrand NameDate Report Received
KAKOGAWA FACTORY SYSMEX XS-1000IAL 12/20/2022
SYSMEX CORPORATION, I SQUARE SYSMEX XN-10 06/20/2022
ABBOTT DIAGNOSTICS DIVISION CELL-DYN RUBY ANALYZER 06/07/2019
BECKMAN COULTER COULTER LH500 HEMATOLOGY ANALYZER 03/31/2016
BECKMAN COULTER COULTER LH780 HEMATOLOGY ANALYZER 03/18/2016
BECKMAN COULTER LH 500 HEMATOLOGY ANALYZER 02/04/2014
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