FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Ear, Nose, Throat ×
3,812 results
241–264 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Jul 09, 2021
Monarch Platform
K211493 · EOQ
Auris Health, Inc.
Ear, Nose, Throat · 57d
Cleared Jun 17, 2021
aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler...
K210883 · EOQ
Ambu A/S
Ear, Nose, Throat · 84d
Cleared Jun 09, 2021
Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model...
K211490 · ERL
Stryker Corporation
Ear, Nose, Throat · 27d
Cleared May 11, 2021
HD Mediastinoscope
K202272 · EWY
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 273d
Cleared May 05, 2021
Bose SoundControl Hearing Aids
K211008 · QDD
Bose Corporation
Ear, Nose, Throat · 30d
Cleared Mar 26, 2021
AllerBlock Junior
K201734 · NUP
Nasaleze International, Ltd.
Ear, Nose, Throat · 274d
Cleared Mar 11, 2021
Monarch Bronchoscope
K203614 · QNW
Auris Health, Inc., A Johnson and...
Ear, Nose, Throat · 91d
Not Cleared Mar 05, 2021
ClearUP Sinus Relief
DEN200006 · QNU
Tivic Health Systems, Inc.
Ear, Nose, Throat · 392d
Cleared Mar 03, 2021
Ponto Bone Anchored Hearing System, MONO Surgery Kit
K203807 · MAH
Oticon Medical AB
Ear, Nose, Throat · 65d
Cleared Feb 23, 2021
Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6,...
K202048 · LXB
Cochlear Americas
Ear, Nose, Throat · 214d
Cleared Feb 19, 2021
SPiN Vision Video Bronchoscope System
K202346 · EOQ
Veran Medical Technologies, Inc.
Ear, Nose, Throat · 185d
Cleared Feb 19, 2021
Eustachi Ear Pressure Relief Device
K203754 · MJV
Exercore, LLC
Ear, Nose, Throat · 58d
Cleared Jan 26, 2021
Airway Mobilescope
K201300 · EOQ
Olympus Medical Systems Corp.
Ear, Nose, Throat · 256d
Cleared Jan 21, 2021
EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III...
K201758 · EOQ
Olympus Medical Systems Corp.
Ear, Nose, Throat · 206d
Cleared Jan 14, 2021
EasyPath RF Introducer Sheath
K200702 · EOQ
Broncus Medical, Inc.
Ear, Nose, Throat · 302d
Cleared Jan 13, 2021
ENTity WiFi Video Nasopharyngoscope System
K200609 · EOB
Optim, LLC
Ear, Nose, Throat · 310d
Cleared Dec 17, 2020
Single Use Grasping Forceps FG-214P, Single Use Grasping Forceps FG-220P,...
K200342 · EOQ
Olympus Medical Systems Corp.
Ear, Nose, Throat · 310d
Cleared Dec 08, 2020
Novapak Nasal Sinus Packing and Stent
K202623 · LYA
Medtronic Xomed
Ear, Nose, Throat · 89d
Cleared Nov 16, 2020
Ion Endoluminal System
K202370 · EOQ
Intuitive Surgical, Inc.
Ear, Nose, Throat · 89d
Cleared Nov 12, 2020
Insight Infrared Video Goggles
K203082 · GWN
Vestibular First
Ear, Nose, Throat · 30d
Cleared Nov 05, 2020
OtoSet- Ear Cleaning System
K201877 · KYZ
Safkan, Inc.
Ear, Nose, Throat · 121d
Cleared Oct 22, 2020
UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N...
K200318 · ERL
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 258d
Cleared Oct 22, 2020
Broncoflex Agile
K202180 · EOQ
Axess Vision Technology
Ear, Nose, Throat · 79d
Cleared Oct 15, 2020
SINUSPRIME Dilation System
K201398 · LRC
Stryker Ent
Ear, Nose, Throat · 140d