38 results
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61ms
·
Sources: EU EUDAMED, US FDA
Filters
FDA Adverse Event
×
SYSMEX XE-2100
FDA Adverse Event
Malfunction
·SYSMEX AMERICA, INC·Product code GKZ·February 23, 2010
SYSMEX WORK AREA MANAGEMENT SYSTEM (MDDS)
FDA Adverse Event
Malfunction
·SYSMEX AMERICA INC.·Product code OUG·September 11, 2015
HEMATOLOGY ANALYZER
FDA Adverse Event
Other
·SYSMEX AMERICA, INC.·Product code GKZ·March 1, 2004
SYSMEX WORK AREA MANAGER (WAM)
FDA Adverse Event
Malfunction
·SYSMEX AMERICA, INC.·Product code OUG·March 28, 2012
SYSMEX WORK AREA MANAGER SYSTEM
FDA Adverse Event
Malfunction
·SYSMEX AMERICA INC.·Product code OUG·September 10, 2015
SYSMEX XT
FDA Adverse Event
Malfunction
·SYSMEX AMERICA, INC.·Product code GKL·April 10, 2007
UDM-IPU
FDA Adverse Event
Malfunction
·SYSMEX AMERICA INC.·Product code OUG·July 1, 2024
SYSMEX UF-1000I
FDA Adverse Event
SYSMEX AMERICA, INC.·Product code LKM·February 6, 2014
SYSMEX XN-10
FDA Adverse Event
Malfunction
·SYSMEX AMERICA INC.·Product code GKZ·September 22, 2014
CARESPHERE WORKFLOW SOLUTION
FDA Adverse Event
Malfunction
·SYSMEX AMERICA INC.·Product code JQP·February 9, 2023
*
FDA Adverse Event
Malfunction
·SYSMEX AMERICA, INC.·Product code GKZ·March 20, 2009
SYSMEX
FDA Adverse Event
Malfunction
·SYSMEX AMERICA, INC.·Product code GKZ·March 15, 2016
SYSMEX WORK AREA MANAGEMENT SYSTEM (MDDS)
FDA Adverse Event
Injury
·SYSMEX AMERICA INC.·Product code OUG·March 10, 2016
SYSMEX WORK AREA MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·SYSMEX AMERICA INC.·Product code OUG·January 29, 2016
SYSMEX WORK AREA MANAGER SYSTEM
FDA Adverse Event
Injury
·SYSMEX AMERICA INC.·Product code OUG·January 12, 2017
XN HEMATOLOGY ANALYZER SORTER
FDA Adverse Event
Injury
·SYSMEX AMERICA, INC.·Product code GKZ·December 30, 2024
SYSMEX WORK AREA MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·SYSMEX AMERICA INC.·Product code OUG·April 21, 2016
SYSMEX WORK AREA MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·SYSMEX AMERICA INC.·Product code OUG·March 17, 2020
SYSMEX HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·SYSMEX AMERICA, INC.·Product code GKZ·November 3, 2023
SYSMEX WORK AREA MANAGEMENT SYSTEM (MDDS)
FDA Adverse Event
Other
·SYSMEX AMERICA INC.·Product code GKZ·October 16, 2013