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
121–144 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Jan 18, 2024
PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope...
K232860 · EOQ
Pentax of America, Inc.
Ear, Nose, Throat · 125d
Cleared Jan 12, 2024
PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single...
K231970 · EOQ
Pentax of America, Inc.
Ear, Nose, Throat · 193d
Cleared Jan 04, 2024
Ambu® aScope™ 5 Broncho 4.2/2.2
K233671 · EOQ
Ambu A/S
Ear, Nose, Throat · 50d
Cleared Dec 21, 2023
Disposable Laryngeal Electrodes
K232888 · ETN
Suzhou Haishen Medical Device...
Ear, Nose, Throat · 94d
Cleared Dec 18, 2023
Ion Endoluminal System (IF1000)
K232984 · EOQ
Intuitive Surgical, Inc.
Ear, Nose, Throat · 87d
Cleared Dec 13, 2023
ACCLARENT AERA Eustachian Tube Dilation System
K230742 · PNZ
Acclarent, Inc.
Ear, Nose, Throat · 271d
Not Cleared Dec 04, 2023
Sonu
DEN230045 · QZC
Sound Health Systems, Inc.
Ear, Nose, Throat · 171d
Cleared Nov 28, 2023
Monarch Bronchoscope
K231473 · QNW
Auris Health, Inc., A Johnson and...
Ear, Nose, Throat · 190d
Cleared Nov 24, 2023
Tympanostomy Tubes
K232059 · ETD
Grace Medical, Inc.
Ear, Nose, Throat · 136d
Cleared Nov 15, 2023
METIC™- Airway Balloon Catheter
K231818 · KTI
M/S Meril Life Sciences Pvt. , Ltd.
Ear, Nose, Throat · 147d
Cleared Nov 14, 2023
Broncho Videoscope System
K231521 · EOQ
Scivita Medical Technology Co., Ltd.
Ear, Nose, Throat · 172d
Cleared Oct 27, 2023
hearOAE
K231545 · EWO
Hearx SA (Pty) , Ltd.
Ear, Nose, Throat · 150d
Cleared Oct 26, 2023
NIM Standard Reinforced EMG Endotracheal Tube
K230320 · ETN
Medtronic Xomed, Inc.
Ear, Nose, Throat · 262d
Cleared Oct 26, 2023
Sontro® OTC Hearing Aids (AI)
K231550 · QUH
Soundwave Hearing, LLC
Ear, Nose, Throat · 149d
Cleared Oct 17, 2023
Lumen 155-SF
K223911 · QDD
Intricon Corporation
Ear, Nose, Throat · 292d
Cleared Sep 25, 2023
Self-Fitting hearing aids
K221052 · QUH
Huizhou Jinghao Medical Technology...
Ear, Nose, Throat · 532d
Cleared Sep 20, 2023
Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set
K232582 · EOQ
Ambu A/S
Ear, Nose, Throat · 26d
Cleared Sep 08, 2023
Intrisound™ Tuned Lumen® 155 Hearing Aids
K223848 · QUH
Tuned , Ltd.
Ear, Nose, Throat · 260d
Cleared Sep 07, 2023
Radio Frequency Plasma Surgical Systems
K221743 · GEI
Jiangsu Bonss Medical Technology Co.,...
Ear, Nose, Throat · 449d
Cleared Aug 30, 2023
NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)
K231580 · ETN
Medtronic Xomed, Inc.
Ear, Nose, Throat · 91d
Cleared Aug 18, 2023
Cochlear™ Osia® System
K231204 · PFO
Cochlear
Ear, Nose, Throat · 113d
Cleared Aug 17, 2023
Spirair Nasal Septal Strap
K223167 · NHB
Spirair, Inc.
Ear, Nose, Throat · 314d
Cleared Aug 10, 2023
Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aBox™ 2
K230428 · EOQ
Ambu A/S
Ear, Nose, Throat · 174d
Cleared Aug 03, 2023
TubaVent Balloon Dilatation System
K223542 · PNZ
Spiggle & Theis Medizintechnik GmbH
Ear, Nose, Throat · 251d