37 results · 23ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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