26 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Q13 SPIROLYSER®
FDA 510(k)
FDA Class 2
·Anesthesiology
CLEARARCH
FDA 510(k)
FDA Class 2
·Dental
RIGIDOMETER, MODEL DIR-4U
FDA 510(k)
FDA Unclassified
·Unknown
SAPPHIRE M.T INFUSION PUMP - FRENCH
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·December 23, 2024
UNKNOWN SAPPHIRE PUMP
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·August 6, 2025
SAPPHIRE M.T INFUSION PUMP - FRENCH
FDA Adverse Event
Injury
·EITAN MEDICAL LTD.·Product code FRN·March 17, 2026
SAPPHIRE M.T INFUSION PUMP - FRENCH
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·May 26, 2026
UNKNOWN SAPPHIRE PUMP
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·February 2, 2026
SAPPHIRE M.T INFUSION PUMP - GERMAN
FDA Adverse Event
Death
·EITAN MEDICAL LTD.·Product code FRN·April 28, 2025
SAPPHIRE M.T INFUSION PUMP - FRENCH
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·March 24, 2025
KRD DEVICE, EMBOLIZATION, VASCULAR
FDA Adverse Event
Malfunction
·COOK INC·Product code KRD·September 19, 2019
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 14, 2011
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 3, 2013
REALIZE ADJ GASTRIC BAND STR
FDA Adverse Event
Injury
·OBTECH MEDICAL SARL·Product code LTI·September 16, 2008
ARTOURA BREAST TISSUE EXPANDER
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code LCJ·March 31, 2020
RETRACTA DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Injury
·COOK INC·Product code KRD·June 20, 2019
ARTOURA BREAST TISSUE EXPANDER
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code LCJ·May 26, 2022
ARTOURA BREAST TISSUE EXPANDER
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code LCJ·October 10, 2020
RETRACTA DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Malfunction
·COOK INC·Product code KRD·September 17, 2018
RETRACTA DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Malfunction
·COOK INC·Product code KRD·September 17, 2018