60 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LASEMAR 800, 1000, 1500
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
POWDER-FREE LATEX EXAM GLOVES WITH CHOCOLATE SCENTING AND PROTEIN LABELING CLAIM (<50UG/G)
FDA 510(k)
FDA Class 1
·General Hospital
MODEL 6900GE-64: C-SPINE ARRAY
FDA 510(k)
FDA Class 2
·Radiology
SAPPHIRE M.T INFUSION PUMP - FRENCH
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·April 10, 2025
SAPPHIRE INFUSION PUMP- ENGLISH
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·February 12, 2025
CADD MEDICATION CASSETTE RESERVOIR
FDA Adverse Event
Malfunction
·SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.·Product code FPA·November 7, 2025
SAPPHIRE INFUSION PUMP- ENGLISH
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·December 9, 2024
SAPPHIRE INFUSION PUMP- ENGLISH
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·December 9, 2024
SAPPHIRE M.T INFUSION PUMP - FRENCH
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·April 29, 2025
SAPPHIRE M.T INFUSION PUMP - GERMAN
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·September 2, 2025
SAPPHIRE M.T INFUSION PUMP - FRENCH
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·May 28, 2025
SAPPHIRE M.T INFUSION PUMP - GERMAN
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·September 2, 2025
SAPPHIRE M.T INFUSION PUMP - FRENCH
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·March 24, 2025
SAPPHIRE INFUSION PUMP- ENGLISH
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·August 22, 2024
SAPPHIRE M.T INFUSION PUMP - FRENCH
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·October 22, 2024
CADD CASSETTE RESERVOIR
FDA Adverse Event
Malfunction
·ICU MEDICAL MANUFACTURING S.A. DE C.V.·Product code FPA·October 28, 2025
CADD CASSETTE RESERVOIR
FDA Adverse Event
Malfunction
·ICU MEDICAL MANUFACTURING S.A. DE C.V.·Product code FPA·October 28, 2025
SAPPHIRE M.T INFUSION PUMP - FRENCH
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·November 19, 2025
SAPPHIRE M.T INFUSION PUMP - FRENCH
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·November 19, 2025
SAPPHIRE M.T INFUSION PUMP - GERMAN
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·September 2, 2025