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
337–360 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Jan 04, 2019
GlideScope BFlex Single-Use Bronchoscope System
K183256 · EOQ
Verathon Medical (Canada) Ulc
Ear, Nose, Throat · 44d
Cleared Dec 20, 2018
Sinusway Dilation System
K181838 · LRC
3nt Medical , Ltd.
Ear, Nose, Throat · 163d
Cleared Dec 19, 2018
FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator
K180863 · BTA
Taidoc Technology Corporation
Ear, Nose, Throat · 261d
Cleared Dec 19, 2018
BA310 Abutment, BIA310 Implant/Abutment
K182116 · MAH
Cochlear Americas
Ear, Nose, Throat · 135d
Cleared Dec 06, 2018
Elevo® Kit Snoring Intervention Device
K181107 · LRK
Zelegent, Inc.
Ear, Nose, Throat · 224d
Cleared Nov 30, 2018
Tinnitus Sound Generator Module
K180495 · KLW
GN Hearing A/S
Ear, Nose, Throat · 277d
Cleared Nov 30, 2018
Ambu aScope RLS Slim
K181286 · EOB
Ambu A/S
Ear, Nose, Throat · 198d
Cleared Nov 30, 2018
ChitoZolve
K181696 · LYA
Gyrus Acmi, Inc.
Ear, Nose, Throat · 156d
Cleared Nov 15, 2018
PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor
K181292 · EOX
Cogentix Medical, Inc.
Ear, Nose, Throat · 183d
Cleared Nov 08, 2018
Silk Voice
K180631 · MIX
Sofregen Medical, Inc.
Ear, Nose, Throat · 244d
Cleared Nov 06, 2018
BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider
K182451 · GEI
Covidien, LLC
Ear, Nose, Throat · 60d
Not Cleared Oct 05, 2018
Bose Hearing Aid
DEN180026 · QDD
Bose Corporation
Ear, Nose, Throat · 147d
Cleared Oct 04, 2018
Rhino-Laryngo Fiberscope Olympus ENF-GP2
K181240 · EOB
Olympus Medical Systems Corp.
Ear, Nose, Throat · 147d
Cleared Sep 14, 2018
DizzyDoctor System 1.0.0
K182214 · GWN
Dizzydoctor Systems, LLC
Ear, Nose, Throat · 30d
Cleared Aug 16, 2018
Bongo
K180619 · OHP
Innomed Healthscience, Inc.
Ear, Nose, Throat · 160d
Cleared Aug 03, 2018
OptiPillows EPAP Mask
K181219 · LWF
Cpapnea Medical Supply
Ear, Nose, Throat · 88d
Cleared Jul 20, 2018
TruDi NAV Suction Instruments
K180948 · PGW
Acclarent, Inc.
Ear, Nose, Throat · 100d
Not Cleared Jul 20, 2018
Bonebridge
DEN170009 · PFO
Med-El Elektromedizinische Geraete GmbH
Ear, Nose, Throat · 522d
Cleared Jul 18, 2018
PENTAX Medical VIVIDEO ENT Videoscope Solution
K171011 · EOB
Pentax Medical
Ear, Nose, Throat · 470d
Cleared Jul 13, 2018
Tinnitus Sound Generator Module
K181586 · KLW
GN Hearing A/S
Ear, Nose, Throat · 28d
Cleared Jul 03, 2018
PeriView FLEX
K181193 · KTI
Olympus Surgical Technologies America
Ear, Nose, Throat · 60d
Cleared Jun 05, 2018
Lunoa System
K180608 · MYB
Nightbalance BV
Ear, Nose, Throat · 90d
Cleared May 11, 2018
GSI Corti
K180287 · EWO
Grason-Stadler, Inc.
Ear, Nose, Throat · 99d
Cleared Apr 30, 2018
EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy...
K172726 · EOQ
Olympus Medical Systems Corp.
Ear, Nose, Throat · 231d