657 results · 29ms · Sources: EU EUDAMED, US FDA

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ACCLARENT PIVOT NAVIGATION BALLOON DILATION SYSTEM

FDA Adverse Event
Malfunction ·ACCLARENT, INC.·Product code PGW·April 24, 2024

ACCLARENT PIVOT NAVIGATION BALLOON DILATION SYSTEM

FDA Adverse Event
Malfunction ·ACCLARENT, INC.·Product code PGW·March 21, 2022

ACCLARENT PIVOT NAVIGATION BALLOON DILATION SYSTEM

FDA Adverse Event
Malfunction ·ACCLARENT, INC.·Product code PGW·June 3, 2022

ACCLARENT PIVOT NAVIGATION BALLOON DILATION SYSTEM

FDA Adverse Event
Injury ·ACCLARENT, INC.·Product code PGW·June 7, 2023

ACCLARENT PIVOT NAVIGATION BALLOON DILATION SYSTEM

FDA Adverse Event
Malfunction ·ACCLARENT, INC.·Product code PGW·March 8, 2022

ACCLARENT AERA

FDA Adverse Event
Malfunction ·ACCLARENT, INC.·Product code PNZ·October 10, 2017

ACCLARENT AERA EUSTACHIAN TUBE BALLOON DILATION SYSTEM, 5PK

FDA Adverse Event
Injury ·ACCLARENT, INC.·Product code PNZ·August 5, 2024

ACCLARENT AERA EUSTACHIAN TUBE BALLOON DILATION SYSTEM, 1PK

FDA Adverse Event
Injury ·ACCLARENT, INC.·Product code PNZ·July 9, 2024

UNKNOWN_INSTRUMENTS_PRODUCT

FDA Adverse Event
Injury ·STRYKER INSTRUMENTS-KALAMAZOO·Product code PNZ·July 24, 2024

XPRESS LOPROFILE ENT DILATION SYSTEM

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS·Product code PNZ·November 19, 2025

XPRESS LOPROFILE ENT 6X20MM, FINAL PACKA

FDA Adverse Event
Injury ·STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP·Product code PNZ·December 16, 2025

UNKNOWN BALLOON CATHETER 1ST GEN

FDA Adverse Event
Injury ·ACCLARENT, INC.·Product code PNZ·September 14, 2020

EUSTACHIAN TUBE BALLOON DILATION DEVICE

FDA Adverse Event
Injury ·UNKNOWN·Product code PNZ·May 13, 2024

ACCLARENT AERA EUSTACHIAN TUBE BALLOON DILATION SYSTEM, 5PK

FDA Adverse Event
Malfunction ·ACCLARENT, INC.·Product code PNZ·August 24, 2023

UNK_EUSTACHIAN TUBE

FDA Adverse Event
Injury ·ACCLARENT, INC.·Product code PNZ·May 1, 2024

EUSTACHIAN TUBE BALLOON DILATION DEVICE

FDA Adverse Event
Injury ·UNKNOWN·Product code PNZ·May 13, 2024

XPRESS ULTRA 6X20MM US

FDA Adverse Event
Injury ·ENTELLUS MEDICAL, INC.·Product code PNZ·July 29, 2021

ACCLARENT AERA EUSTACHIAN TUBE BALLOON DILATION SYSTEM, 5PK

FDA Adverse Event
Injury ·ACCLARENT, INC.·Product code PNZ·April 15, 2019

ACCLARENT AERA EUSTACHIAN TUBE BALLOON DILATION SYSTEM, 5PK

FDA Adverse Event
Injury ·ACCLARENT, INC.·Product code PNZ·May 4, 2023

EZDILATE BALLOON DILATOR (FW) 6-7-8

FDA Adverse Event
Malfunction ·GYRUS ACMI, INC.·Product code PNZ·August 29, 2022