Acclarent, Inc. - FDA 510(k) Cleared Devices
45
Total
44
Cleared
1
Denied
FDA 510(k) cleared devices by Acclarent, Inc. Ear, Nose, Throat ✕
34 devices
Cleared
Feb 19, 2026
Acclarent AERA Eustachian Tube Balloon Dilation System
Ear, Nose, Throat
93d
Cleared
Dec 13, 2023
ACCLARENT AERA Eustachian Tube Dilation System
Ear, Nose, Throat
271d
Cleared
Jul 21, 2023
TruDi® Navigation System V3 (FG-2000-00)
Ear, Nose, Throat
28d
Cleared
Jul 20, 2022
TruDi Shaver Blade
Ear, Nose, Throat
104d
Cleared
Aug 27, 2020
Next Generation Balloon Dilation System
Ear, Nose, Throat
122d
Cleared
Aug 12, 2020
TruDi Curette
Ear, Nose, Throat
103d
Cleared
Mar 23, 2020
TruDi Probe
Ear, Nose, Throat
101d
Cleared
May 03, 2019
RELIEVA ULTIRRA Sinus Balloon Catheter
Ear, Nose, Throat
60d
Cleared
May 03, 2019
TruDi NAV Wire
Ear, Nose, Throat
60d
Cleared
Apr 19, 2019
Relieva Tract Balloon Dilation System
Ear, Nose, Throat
164d
Cleared
Jul 20, 2018
TruDi NAV Suction Instruments
Ear, Nose, Throat
100d
Cleared
Mar 10, 2018
Acclarent ENT Navigation System
Ear, Nose, Throat
106d