2,096 results
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45ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FACSTRAK FLOW CYTOMETER
FDA 510(k)
FDA Class 2
·Hematology
FACSORT FLOW CYTOMETER
FDA 510(k)
FDA Class 2
·Hematology
NAVIOS FLOW CYTOMETER SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer
FDA 510(k)
FDA Class 2
·Hematology
Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 Laser
FDA 510(k)
FDA Class 2
·Hematology
DxFLEX Flow Cytometer; ClearLLab 10C Panels
FDA 510(k)
FDA Class 2
·Hematology
FACSCAN FLOW CYTOMETER - RETICCOUNT RETI. ENU. KIT
FDA 510(k)
FDA Class 2
·Hematology
CYTOMICS FC 500 MPL FLOW CYTOMETER, MODEL # 626554
FDA 510(k)
FDA Class 2
·Hematology
BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration)
FDA 510(k)
FDA Class 2
·Hematology
Cytomics FC 500 Series (MPL or MCL) Flow Cytometer
FDA 510(k)
FDA Class 2
·Hematology
FACSCOMP SOFTWARE AND CALIBRITE BEADS FOR USE IN FLOW CYTOMETER INSTRUMENT SET
FDA 510(k)
FDA Class 2
·Hematology
NAVIOS? FLOW CYTOMETER SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code OYE·January 16, 2014
NAVIOS FLOW CYTOMETER SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code OYE·September 11, 2014
NAVIOS FLOW CYTOMETER SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code OYE·January 14, 2015
NAVIOS FLOW CYTOMETER SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code OYE·September 16, 2014
BD FACSVIA¿ FLOW CYTOMETER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·December 21, 2023
COBAS B 221 <6> SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code KHG·August 22, 2025
BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962
FDA 510(k)
FDA Class 2
·Hematology
CYTOMICS® FC500 FLOW CYTOMETER SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·December 13, 2013
FC 500 FLOW CYTOMETER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·April 22, 2022