15 results
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51ms
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Sources: EU EUDAMED, US FDA
Monarch Medical Technologies
FDA registration
Monarch Medical Technologies·1 product·🇺🇸 United States
EndoTool
FDA UDI
MONARCH MEDICAL TECHNOLOGIES LLC·00860003340608·EndoTool is a glucose management software syste...
EndoTool IV
FDA UDI
MONARCH MEDICAL TECHNOLOGIES LLC·00860003340615·EndoTool is a glucose management software syste...
EndoTool SubQ
FDA UDI
MONARCH MEDICAL TECHNOLOGIES LLC·00860003340622·EndoTool SubQ is a software application for use...
EndoTool IV
FDA UDI
MONARCH MEDICAL TECHNOLOGIES LLC·00860003340639·EndoTool IV is a glucose management software s...
Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10.
FDA Enforcement
Class II
·Ongoing·Monarch Medical Technologies·June 26, 2019
ENDOTOOL
FDA Adverse Event
MONARCH MEDICAL TECHNOLOGIES·Product code NDC·July 17, 2020
ENDOTOOL IV
FDA Adverse Event
Injury
·MONARCH MEDICAL TECHNOLOGIES·Product code NDC·September 10, 2020
ENDOTOOL IV
FDA Adverse Event
Malfunction
·MONARCH MEDICAL TECHNOLOGIES·Product code NDC·April 21, 2020
ENDOTOOL IV
FDA Adverse Event
Malfunction
·MONARCH MEDICAL TECHNOLOGIES·Product code NDC·June 27, 2019
ENDOTOOL IV
FDA Adverse Event
Malfunction
·MONARCH MEDICAL TECHNOLOGIES·Product code NDC·May 29, 2019
ENDOTOOL SUBQ
FDA Adverse Event
Malfunction
·MONARCH MEDICAL TECHNOLOGIES·Product code NDC·March 25, 2020
Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10.
FDA Recall
Open, Classified
·Monarch Medical Technologies·Product code NDC·May 3, 2019
EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5)
FDA Recall
Terminated
·Monarch Medical Technologies·Product code NDC·October 1, 2019
EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5)
FDA Enforcement
Class II
·Terminated·Monarch Medical Technologies·November 20, 2019