37 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RX Takeru Balloon Dilatation Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LOX·March 17, 2020
IKAZUCHI ZERO
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LOX·June 13, 2019
KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LOX·August 19, 2019
IKAZUCHI ZERO
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LOX·August 20, 2019
KANEKA PTCA CATHETER CO-R7(IKAZUCHI ZERO)
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LOX·August 21, 2019
KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)
FDA Adverse Event
Malfunction
·KANEKA CORPORATION·Product code LOX·April 14, 2022
KANEKA PTCA CATHETER CO-R8 (TASUKI)
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LOX·December 13, 2020
KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)
FDA Adverse Event
Malfunction
·KANEKA CORPORATION·Product code LOX·December 21, 2020
KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)
FDA Adverse Event
Malfunction
·KANEKA CORPORATION·Product code LOX·April 13, 2022
KANEKA PTCA CATHETER CO-R6 (RAIDEN3)
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LOX·June 6, 2025
KANEKA PTCA CATHETER ZINRAI
FDA Adverse Event
Death
·KANEKA CORPORATION·Product code LOX·February 3, 2025
KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LOX·December 21, 2017
KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)
FDA Adverse Event
Death
·KANEKA CORPORATION·Product code LOX·April 14, 2021
KANEKA PTCA CATHETER CO-R6 (RAIDEN3)
FDA Adverse Event
Death
·KANEKA CORPORATION·Product code LOX·December 7, 2021
KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LOX·July 30, 2024
NEON PTCA BALLOON DILATATION CATHETER
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LOX·August 27, 2023
KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LOX·September 30, 2020
KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)
FDA Adverse Event
Malfunction
·KANEKA CORPORATION·Product code LOX·October 29, 2021
KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)
FDA Adverse Event
Death
·KANEKA CORPORATION·Product code LOX·February 24, 2021