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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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8 records meeting your search criteria returned- Product Code: GKZ Product Problem: Computer Software Problem Report Date From: 01/1/2009
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ManufacturerBrand NameDate Report Received
ABBOTT LABORATORIES CELL-DYN RUBY SYSTEM 03/21/2022
SIEMENS HEALTHCARE DIAGNOSTICS INC ADVIA 120 HEMATOLOGY SYSTEM WITH AUTOSAM 02/27/2019
ABBOTT DIAGNOSTICS DIVISION CELL-DYN SAPPHIRE ANALYZER 10/23/2018
SYSMEX CORPORATION XN-10 12/02/2016
SYSMEX CORPORATION XN-10 06/02/2016
BECKMAN COULTER UNICEL DXH 600 COULTER CELLULAR ANALYSIS 11/17/2015
BECKMAN COULTER COULTER LH 500 HEMATOLOGY ANALYZER 11/02/2015
BECKMAN COULTER COULTER LH 780 HEMATOLOGY ANALYZER 04/27/2015
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