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
49–72 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Sep 05, 2025
Ion Endoluminal System (IF1000)
K252528 · EOQ
Intuitive Surgical, Inc.
Ear, Nose, Throat · 25d
Cleared Aug 27, 2025
Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US)
K251752 · EOQ
Shanghai AnQing Medical Instrument...
Ear, Nose, Throat · 79d
Cleared Aug 25, 2025
NeuroEars-Anna™
K243709 · GWN
Neuroears, Inc.
Ear, Nose, Throat · 266d
Cleared Aug 11, 2025
UE BRONCHO Single-Use Bronchoscopes (EBS-380C)
K251823 · EOQ
Zhejiang UE Medical Corp.
Ear, Nose, Throat · 59d
Cleared Aug 11, 2025
Outlook Surgical Versa One System (8900139)
K241731 · EOB
Resnent, LLC
Ear, Nose, Throat · 420d
Cleared Jul 25, 2025
Vathin® Video Bronchoscope System
K250232 · EOQ
Hunan Vathin Medical Instrument Co.,...
Ear, Nose, Throat · 179d
Cleared Jul 11, 2025
TurbAlign
K243655 · LYA
Spirair, Inc.
Ear, Nose, Throat · 227d
Cleared Jul 03, 2025
Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed...
K243280 · ERL
W&H Dentalwerk Buermoos GmbH
Ear, Nose, Throat · 259d
Cleared Jun 23, 2025
EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190)
K250862 · EOQ
Olympus Medical Systems Corp.
Ear, Nose, Throat · 94d
Cleared Jun 20, 2025
Navient Image Guided Navigation System (ENT) (955-NC-NC)
K243053 · PGW
Claronav
Ear, Nose, Throat · 266d
Cleared Jun 13, 2025
FUJIFILM Endoscope Model EB-710P
K244017 · EOQ
Fujifilm Corporation
Ear, Nose, Throat · 168d
Cleared Jun 13, 2025
ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845),...
K242852 · ETN
Inomed Medizintechnik GmbH
Ear, Nose, Throat · 266d
Cleared Jun 06, 2025
Baby Nasal Aspirator (BN002)
K251450 · BTA
Shenzhen Desida Technology Co., Ltd.
Ear, Nose, Throat · 28d
Cleared Jun 05, 2025
Portare System (FA-001)
K243639 · EOB
Grumpy Innovation, Inc.
Ear, Nose, Throat · 192d
Cleared May 29, 2025
Baha 7 Sound Processor
K250215 · LXB
Cochlear
Ear, Nose, Throat · 125d
Cleared May 29, 2025
NEUROMARK System (NMK00301)
K250048 · GEI
Neurent Medical , Ltd.
Ear, Nose, Throat · 139d
Cleared May 29, 2025
Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU,...
K243497 · EOQ
Shanghai AnQing Medical Instrument...
Ear, Nose, Throat · 198d
Cleared May 28, 2025
Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0
K242793 · EOQ
Shenzhen Insighters Medical...
Ear, Nose, Throat · 254d
Cleared May 16, 2025
Electric Nasal Aspirator...
K244033 · BTA
Shenzhen Desida Technology Co., Ltd.
Ear, Nose, Throat · 137d
Cleared Apr 30, 2025
LumiRex Bronchoscope
K243541 · EOQ
Contra Healthcare Solutions, LLC
Ear, Nose, Throat · 166d
Cleared Apr 28, 2025
Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy...
K250256 · ETD
Aventamed Dac
Ear, Nose, Throat · 90d
Cleared Apr 25, 2025
contact forte Alpha
K243041 · LXB
Bhm-Tech Produktionsgesellschaft Mbh
Ear, Nose, Throat · 210d
Cleared Apr 24, 2025
Sonu
K242214 · QZC
Sound Health Systems, Inc.
Ear, Nose, Throat · 269d
Cleared Apr 23, 2025
Electric Nasal Aspirator (BC026, BC025, BC023)
K250697 · BTA
Shenzhen Kingboom Technology Co., Ltd.
Ear, Nose, Throat · 47d