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
169–192 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Feb 01, 2023
Tinnitogram Signal Generator
K221168 · KLW
Goldenear Company, Inc.
Ear, Nose, Throat · 285d
Cleared Jan 27, 2023
C2 Xplore
K223254 · ETN
Inomed Medizintechnik GmbH
Ear, Nose, Throat · 98d
Cleared Jan 12, 2023
Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD...
K223782 · EOQ
Ambu A/S
Ear, Nose, Throat · 27d
Cleared Jan 04, 2023
SilentCloud
K221125 · KLW
Aureliym GmbH
Ear, Nose, Throat · 261d
Cleared Dec 28, 2022
RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP
K221660 · EOB
Olympus Medical Systems Corp.
Ear, Nose, Throat · 203d
Cleared Dec 21, 2022
PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System
K213235 · EOQ
Pentax of America, Inc.
Ear, Nose, Throat · 447d
Cleared Dec 21, 2022
Eargo 5 , Eargo 6
K221698 · QUH
Eargo, Inc.
Ear, Nose, Throat · 191d
Cleared Dec 02, 2022
PENTAX Medical Video Esophagoscope EE17-J10
K223072 · EOX
Pentax of America, Inc.
Ear, Nose, Throat · 63d
Cleared Nov 18, 2022
Single-Use Flexible Rhinolaryngoscope
K221581 · EOB
Hunan Vathin Medical Instrument Co.,...
Ear, Nose, Throat · 170d
Cleared Nov 16, 2022
PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX...
K220465 · EOB
Pentax of America, Inc.
Ear, Nose, Throat · 272d
Cleared Nov 14, 2022
PosiSep X BAM Hemostat Dressing/Intranasal Splint
K220326 · EMX
Hemostasis, LLC
Ear, Nose, Throat · 283d
Cleared Nov 10, 2022
FUJIFILM Endoscope Model EB-710P
K220957 · EOQ
Fujifilm Corporaton
Ear, Nose, Throat · 223d
Cleared Nov 02, 2022
ORiGO System
K221184 · ERL
Bien-Air Surgery SA
Ear, Nose, Throat · 191d
Cleared Oct 30, 2022
Nuheara IQbuds 2 PRO Hearing Aid
K221064 · QUH
Nuheara Limited
Ear, Nose, Throat · 202d
Cleared Oct 26, 2022
NEUROMARK System
K222032 · GEI
Neurent Medical
Ear, Nose, Throat · 107d
Cleared Oct 20, 2022
Electric nasal aspirator
K222547 · BTA
Shenzhen Xinlianfeng Technology Co.,Ltd
Ear, Nose, Throat · 58d
Cleared Oct 05, 2022
VISIONAIR
K221892 · BXQ
Pacificmd Biotech, LLC
Ear, Nose, Throat · 98d
Cleared Sep 26, 2022
Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal Intubation...
K221631 · EOQ
Olympus Medical Systems Corp.
Ear, Nose, Throat · 112d
Cleared Sep 26, 2022
OtoSight Middle Ear Scope
K222655 · QJG
Photonicare, Inc.
Ear, Nose, Throat · 24d
Cleared Sep 19, 2022
Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3
K221638 · EOB
Olympus Medical Systems Corp.
Ear, Nose, Throat · 105d
Not Cleared Sep 16, 2022
Phagenyx System
DEN220025 · QQG
Phagenesis Limited
Ear, Nose, Throat · 150d
Cleared Aug 15, 2022
Recon Steerable Sheath
K221302 · EOQ
Serpex Medical, Inc.
Ear, Nose, Throat · 102d
Cleared Aug 12, 2022
Vibe SF Self-Fitting Hearing Aid
K220403 · QDD
Wsaud A/S
Ear, Nose, Throat · 182d
Cleared Aug 04, 2022
MDHearingAid app, MDHearingAid Smart hearing aids
K220303 · QDD
Mdhearingaid
Ear, Nose, Throat · 183d