Search FDA 510(k) Devices

4,872 clearances indexed · Search by device name, K-number, manufacturer or product code

45 results for "Acclarent, Inc."
1–24 of 45
Cleared Feb 19, 2026
Acclarent AERA Eustachian Tube Balloon Dilation System
K253612 · PNZ
Acclarent, Inc.
Ear, Nose, Throat · 93d
Cleared Dec 13, 2023
ACCLARENT AERA Eustachian Tube Dilation System
K230742 · PNZ
Acclarent, Inc.
Ear, Nose, Throat · 271d
Cleared Jul 21, 2023
TruDi® Navigation System V3 (FG-2000-00)
K231862 · PGW
Acclarent, Inc.
Ear, Nose, Throat · 28d
Cleared Jul 20, 2022
TruDi Shaver Blade
K221037 · PGW
Acclarent, Inc.
Ear, Nose, Throat · 104d
Cleared Aug 27, 2020
Next Generation Balloon Dilation System
K201115 · LRC
Acclarent, Inc.
Ear, Nose, Throat · 122d
Cleared Aug 12, 2020
TruDi Curette
K201174 · PGW
Acclarent, Inc.
Ear, Nose, Throat · 103d
Cleared Mar 23, 2020
TruDi Probe
K193453 · PGW
Acclarent, Inc.
Ear, Nose, Throat · 101d
Cleared May 03, 2019
TruDi NAV Wire
K190532 · PGW
Acclarent, Inc.
Ear, Nose, Throat · 60d
Cleared May 03, 2019
RELIEVA ULTIRRA Sinus Balloon Catheter
K190525 · LRC
Acclarent, Inc.
Ear, Nose, Throat · 60d
Cleared Apr 19, 2019
Relieva Tract Balloon Dilation System
K183090 · QGK
Acclarent, Inc.
Ear, Nose, Throat · 164d
Cleared Jul 20, 2018
TruDi NAV Suction Instruments
K180948 · PGW
Acclarent, Inc.
Ear, Nose, Throat · 100d
Cleared Mar 10, 2018
Acclarent ENT Navigation System
K173628 · PGW
Acclarent, Inc.
Ear, Nose, Throat · 106d
Cleared Jan 16, 2018
ACCLARENT AERA Eustachian Tube Balloon Dilation System
K171761 · PNZ
Acclarent, Inc.
Ear, Nose, Throat · 216d
Cleared Sep 05, 2017
Relieva SpinPlus Nav Balloon Sinuplasty System
K171687 · LRC
Acclarent, Inc.
Ear, Nose, Throat · 90d
Cleared Oct 24, 2016
Relieva UltirraNav Sinus Balloon Catheter
K161698 · LRC
Acclarent, Inc.
Ear, Nose, Throat · 126d
Cleared Oct 24, 2016
Acclarent NavWire Sinus Navigation Guidewire
K161697 · PGW
Acclarent, Inc.
Ear, Nose, Throat · 126d
Not Cleared Sep 16, 2016
Acclarent Aera Eustachian Tube Balloon Dilation System
DEN150056 · PNZ
Acclarent, Inc.
Ear, Nose, Throat · 284d
Cleared Feb 12, 2016
Relieva Scout Multi-Sinus Dilation System
K153341 · LRC
Acclarent, Inc.
Ear, Nose, Throat · 85d
Cleared May 20, 2015
TULA Iontophoresis System with Earset
K150453 · EGJ
Acclarent, Inc.
Physical Medicine · 89d
Cleared Apr 22, 2015
Relieva SpinPlus Balloon Sinuplasty System
K143541 · LRC
Acclarent, Inc.
Ear, Nose, Throat · 128d
Cleared Apr 07, 2015
ACCLARENT SE Inflation Device
K150172 · LRC
Acclarent, Inc.
Ear, Nose, Throat · 71d
Cleared Apr 24, 2014
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
K132433 · EOB
Acclarent, Inc.
Ear, Nose, Throat · 262d
Cleared Feb 20, 2014
RELIEVA SCOUT SINUS DILATION SYSTEM
K140160 · LRC
Acclarent, Inc.
Ear, Nose, Throat · 29d
Cleared Nov 05, 2012
RELIEVA SEEKER BALLOON SINUPLASTY SYSTEM
K120280 · LRC
Acclarent, Inc.
Ear, Nose, Throat · 280d