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
1–24 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Jul 31, 2026
Hearing Aid Feature
K261187 · SCR
Samsung Electronics Co., Ltd.
Ear, Nose, Throat · 112d
Cleared Jul 30, 2026
SeptAlign (SPLN001)
K260620 · NHB
Spirair, Inc.
Ear, Nose, Throat · 155d
Cleared Jul 30, 2026
SMARTVERTIGO™ Vestibular Assessment System
K260566 · GWN
VertigoDx, Inc.
Ear, Nose, Throat · 161d
Cleared Jul 25, 2026
MONARCH™ Platform (MON-000008)
K260382 · EOQ
Auris Health, Inc.
Ear, Nose, Throat · 170d
Cleared Jul 22, 2026
Ossiclear (Ossiclear System)
K254296 · LXB
Sounduct
Ear, Nose, Throat · 203d
Cleared Jul 13, 2026
Hearing assist
K254044 · SCR
Meta Platform Technologies, LLC
Ear, Nose, Throat · 208d
Cleared Jul 10, 2026
Cochlear™ Osia® 3(I) Sound Processor
K260902 · PFO
Cochlear Americas
Ear, Nose, Throat · 114d
Cleared Jun 25, 2026
Jabra Enhance Select Self-fit (Jabra Enhance Select 550)
K254108 · QUH
GN Hearing A/S
Ear, Nose, Throat · 188d
Cleared Jun 17, 2026
Hydro Irrigation System
K261544 · EOB
Stryker Instruments
Ear, Nose, Throat · 40d
Cleared Jun 16, 2026
NEUROMARK System (NMK00301)
K261833 · GEI
Neurent Medical , Ltd.
Ear, Nose, Throat · 14d
Cleared Jun 16, 2026
FUJIFILM Endoscope Model EB-840S
K253137 · EOQ
Fujifilm Corporation
Ear, Nose, Throat · 264d
Cleared Jun 15, 2026
Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152,...
K260452 · LXB
Zdeer Technology (Henan) Co., Ltd.
Ear, Nose, Throat · 124d
Cleared Jun 11, 2026
Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)
K261256 · LXB
Shenzhen Magnet Technology Co., Ltd.
Ear, Nose, Throat · 56d
Cleared Jun 10, 2026
Tinnitus Therapy
K260614 · KLW
Sivantos GmbH
Ear, Nose, Throat · 105d
Cleared Jun 02, 2026
Cube 4D Navigation System, VirtuEye Pro
K261540 · PGW
Fiagon GmbH
Ear, Nose, Throat · 25d
Cleared May 26, 2026
Momcozy Nasal Aspirator (BN007)
K253629 · BTA
Shenzhen Root Innovation Technology...
Ear, Nose, Throat · 188d
Cleared May 18, 2026
RhinAer+ Stylus
K260522 · GEI
Aerin Medical, Inc.
Ear, Nose, Throat · 90d
Cleared May 15, 2026
Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02
K260134 · BTA
Shenzhen Root Innovation Technology...
Ear, Nose, Throat · 119d
Cleared May 15, 2026
KARL STORZ Laryngoscopes and Accessories
K252624 · EQN
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 270d
Cleared May 14, 2026
ENTity USB Videoscope System
K254133 · EOB
Optim, LLC
Ear, Nose, Throat · 143d
Cleared May 12, 2026
Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)
K260473 · BTA
Shenzhen Kingboom Technology Co., Ltd.
Ear, Nose, Throat · 89d
Cleared Apr 23, 2026
Tula Tympanostomy Tube Delivery Device
K252436 · ETD
Tusker Medical, Inc.
Ear, Nose, Throat · 265d
Cleared Apr 23, 2026
EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190)
K252341 · EOQ
Olympus Medical Systems Corp.
Ear, Nose, Throat · 269d
Cleared Apr 14, 2026
Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)
K253107 · BTA
Shenzhen Dongjiang Technology Co., Ltd.
Ear, Nose, Throat · 202d