34 results · 18ms · Sources: EU EUDAMED, US FDA

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SM-20 CARDIOSCAN DOPPLER OPTION WITH CFM700 PROBES

FDA 510(k)
FDA Class 2 ·Cardiovascular

RX Takeru Balloon Dilatation Catheter

FDA 510(k)
FDA Class 2 ·Cardiovascular

RADIFOCUS GLIDEWIRE ADVANTAGE

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

CAPSURE SP NOVUS

FDA Adverse Event
Injury ·MPRI·Product code DTB·June 10, 2014

SPRINT QUATTRO SECURE

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 9, 2010

INTERMATE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·December 10, 2012

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