77 results
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55ms
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Sources: EU EUDAMED, US FDA
Sysmex America, Inc.
FDA registration
Sysmex America, Inc.·30 products·🇺🇸 United States
SYSMEX AMERICA, INC.
FDA registration
SYSMEX AMERICA, INC.·1 product·🇺🇸 United States
Sysmex America, Inc.
FDA registration
Sysmex America, Inc.·1 product·🇺🇸 United States
SYSMEX REAGENTS AMERICA, INC.
FDA registration
SYSMEX REAGENTS AMERICA, INC.·2 products·🇺🇸 United States
Caresphere Workflow Solution
FDA UDI
Sysmex America, Inc.·00664369000851·
WAM (Work Area Management)
FDA UDI
Sysmex America, Inc.·00664369000752·
Sysmex UF1000i, Automated Urine Particle Analyzer with Urinalysis WAM Software
FDA UDI
Sysmex America, Inc.·00664369000639·Fully Automated Urine Cell Analyzer UF-1000i UF...
Sysmex America, Inc. - Vernon Hills
FDA registration
Sysmex America, Inc. - Vernon Hills·12 products·🇺🇸 United States
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
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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