27 results · 73ms · 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.

JADE 14 OTW PTA BALLOON DILATATION CATHETER

FDA Adverse Event
Malfunction ·ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD·Product code LIT·September 3, 2024

JADE 14 OTW PTA BALLOON DILATATION CATHETER

FDA Adverse Event
Malfunction ·ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD·Product code LIT·August 30, 2024

SAPPHIRE II PRO

FDA Adverse Event
Malfunction ·ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.·Product code LIT·December 8, 2025

JADE PTA BALLOON DILATATION CATHETER

FDA Adverse Event
Malfunction ·ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.·Product code LIT·August 1, 2025

JADE 14 OTW PTA BALLOON DILATATION CATHETER

FDA Adverse Event
Malfunction ·ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD·Product code LIT·August 15, 2025

SAPPHIRE II PRO

FDA Adverse Event
Malfunction ·ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.·Product code LOX·May 11, 2020

SCOREFLEX NC SCORING PTCA CATHETER

FDA Adverse Event
Malfunction ·ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD·Product code NWX·May 15, 2024

JADE

FDA Adverse Event
Malfunction ·ORBUSNEICH MEDICAL (SHENZHEN) CO. LTD.·Product code LIT·September 27, 2021

TELEPORT MICROCATHETER

FDA Adverse Event
Malfunction ·ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.·Product code DQY·April 12, 2019

SAPPHIRE II PRO CORONARY DILATATION CATHETER

FDA Adverse Event
Malfunction ·ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.·Product code LOX·April 13, 2019

TELEPORT MICROCATHETER

FDA Adverse Event
Malfunction ·ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.·Product code DQY·June 1, 2019

SAPPHIRE NC PLUS

FDA Adverse Event
Malfunction ·ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.·Product code LOX·June 19, 2019

SAPPHIRE II PRO BALLOON 1.00MM X 5MM

FDA Adverse Event
Malfunction ·ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.·Product code LIT·June 2, 2023

SCOREFLEX NC SCORING PTCA CATHETER

FDA Adverse Event
Malfunction ·ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD·Product code NWX·March 14, 2024

TELEPORT MICROCATHETER

FDA Adverse Event
Malfunction ·ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.·Product code DQY·March 24, 2019

TELEPORT MICROCATHETER

FDA Adverse Event
Malfunction ·ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.·Product code DQY·March 24, 2019

TELEPORT MICROCATHETER

FDA Adverse Event
Malfunction ·ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.·Product code DQY·March 24, 2019

SAPPHIRE II PRO

FDA Adverse Event
Malfunction ·ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.·Product code LIT·April 9, 2025

SAPPHIRE II PRO BALLOON DILATATION CATHETER

FDA Adverse Event
Malfunction ·ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD·Product code LOX·April 27, 2025

SCOREFLEX NC SCORING PTCA CATHETER

FDA Adverse Event
Malfunction ·ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.·Product code NWX·December 18, 2023