657 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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