17 results · 51ms · Sources: EU EUDAMED, US FDA

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MIVI Q CATHETER

FDA Adverse Event
Malfunction ·MIVI NEUROSCIENCE, INC.·Product code DQY·August 18, 2023

MIVI Q CATHETER

FDA Adverse Event
Injury ·MIVI NEUROSCIENCE, INC.·Product code NRY·September 1, 2023

MODEL Q6-69145

FDA Adverse Event
Injury ·MIVI NEUROSCIENCE, INC.·Product code DQY·June 27, 2019

Q6 ASPIRATION CATHETER

FDA Adverse Event
Injury ·MIVI NEUROSCIENCE, INC.·Product code DQY·April 11, 2019

MIVI Q CATHETER

FDA Adverse Event
Malfunction ·MIVI NEUROSCIENCE, INC.·Product code DQY·January 16, 2023

MIVI Q CATHETER

FDA Adverse Event
Malfunction ·MIVI NEUROSCIENCE, INC.·Product code DQY·May 15, 2023

MIVI Q DISTAL ACCESS CATHETER

FDA Adverse Event
Injury ·MIVI NEUROSCIENCE, INC.·Product code DQY·November 9, 2022

MIVI Q CATHETER

FDA Adverse Event
Injury ·MIVI NEUROSCIENCE, INC.·Product code NRY·October 13, 2023

MIVI Q ASPIRATION CATHETER

FDA Adverse Event
Malfunction ·MIVI NEUROSCIENCE, INC.·Product code DQY·January 26, 2022

MIVI Super 90 Guide Catheters, MIVI Mi-Axus 8F Catheters, REF MIA-9080S (80 cm length); MIA-9090S (90 cm length), and MIA-9095S (95 cm length), MIA-9080-E, MIA-9090S-E, MIA-9095S-E, Sterile. Device is used to facilitate the insertion and guidance of microcatheters into a selected blood vessel in the peripheral, coronary and neuro vascular systems.

FDA Recall
Terminated ·Mivi Neuroscience Inc·Product code DQY·July 23, 2021

MIVI Super 90 8F Guide Catheter, 95 cm, REF MIA-9095S-IDE, For Investigational Use Only; sterile, and Super 90 8F Guide Catheter, 90 cm, REF MIA-9090S-IDE, For Investigational Use Only. Device is used to facilitate the insertion and guidance of microcatheters into a selected blood vessel in the peripheral, coronary and neuro vascular systems.

FDA Recall
Terminated ·Mivi Neuroscience Inc·Product code DQY·July 23, 2021

MIVI Super 90 8F Guide Catheter, 95 cm, REF MIA-9095S-IDE, For Investigational Use Only; sterile, and Super 90 8F Guide Catheter, 90 cm, REF MIA-9090S-IDE, For Investigational Use Only. Device is used to facilitate the insertion and guidance of microcatheters into a selected blood vessel in the peripheral, coronary and neuro vascular systems.

FDA Enforcement
Class II ·Terminated·Mivi Neuroscience Inc·September 15, 2021

MIVI Super 90 Guide Catheters, MIVI Mi-Axus 8F Catheters, REF MIA-9080S (80 cm length); MIA-9090S (90 cm length), and MIA-9095S (95 cm length), MIA-9080-E, MIA-9090S-E, MIA-9095S-E, Sterile. Device is used to facilitate the insertion and guidance of microcatheters into a selected blood vessel in the peripheral, coronary and neuro vascular systems.

FDA Enforcement
Class II ·Terminated·Mivi Neuroscience Inc·September 15, 2021

Angionautix S.L.

Importer
🇪🇸 Spain·2 Manufacturers

ICON (LR) Limited

Authorized representative
🇮🇪 Ireland·37 Manufacturers·384 Devices

DISTRIBUCIONES Y REPRESENTACIONES BIOMÉDICAS DIREX, S.L.

Importer
🇪🇸 Spain·11 Manufacturers

Duomed Belgium NV

Importer
🇧🇪 Belgium·62 Manufacturers