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
601–624 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Aug 30, 2012
DTAD
K121678 · ERL
Gyrus Acmi, Inc.
Ear, Nose, Throat · 84d
Cleared Aug 29, 2012
SINUS DILATION SYSTEM
K121351 · LRC
Entrigue Surgical, Inc.
Ear, Nose, Throat · 117d
Cleared Aug 28, 2012
LARYNGEAL ELECTRODE
K121257 · ETN
Technomed Europe
Ear, Nose, Throat · 124d
Cleared Aug 22, 2012
XPRESS MULTI-SINUS DILATION TOOL
K121943 · LRC
Entellus Medical, Inc.
Ear, Nose, Throat · 50d
Cleared Jul 26, 2012
SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM
K121512 · EWO
Bio-Logic Systems Corp.
Ear, Nose, Throat · 66d
Cleared Jun 28, 2012
CMOS VIDEO RHINO-LARYNGOSCOPE SYSTEM MODEL 11101CM
K103467 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 582d
Cleared Jun 27, 2012
NEXT GEN EMG ENDOTRACHEAL TUBE
K112686 · ETN
Medtronic Xomed, Inc.
Ear, Nose, Throat · 286d
Cleared Jun 20, 2012
E.G. SCAN II ESPHAGOSCOPE SYSTEM
K120702 · EOX
Intromedic Co., Ltd.
Ear, Nose, Throat · 104d
Cleared Jun 12, 2012
INVENT SNORING DEVICE
K120665 · LWF
Ventus Medical, Inc.
Ear, Nose, Throat · 99d
Cleared Jun 06, 2012
ADAPTAIN SOLUBLE IMPLANT MATERIAL
K120220 · KHJ
Ceremed , Inc.
Ear, Nose, Throat · 133d
Cleared May 17, 2012
HAYMAX
K120894 · NUP
Haymax Limited
Ear, Nose, Throat · 55d
Cleared May 17, 2012
XPRESS MULTI-SINUS DILATION TOOL
K121174 · LRC
Entellus Medical, Inc.
Ear, Nose, Throat · 30d
Cleared May 16, 2012
RADIAL JAW 4 PULMONARY BIOPSY FORCEPS
K121186 · BWH
Boston Scientific Corp
Ear, Nose, Throat · 28d
Cleared May 01, 2012
STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM
K112593 · ERL
Stryker Corporation
Ear, Nose, Throat · 237d
Cleared Apr 27, 2012
PATHASSIST LIGHT FIBER
K120962 · LRC
Entellus Medical, Inc.
Ear, Nose, Throat · 28d
Cleared Apr 25, 2012
NASAL/EPISTAXIS PACK
K113585 · LYA
Cogent Therapeutics, LLC
Ear, Nose, Throat · 142d
Cleared Apr 20, 2012
EARLOGIC OAE TESTER
K112992 · EWO
Earlogic Corporation
Ear, Nose, Throat · 197d
Cleared Apr 19, 2012
PRIMUS HEARING INSTRUMENT TEST UNIT
K113831 · ETW
Auditdata A/S
Ear, Nose, Throat · 114d
Cleared Apr 13, 2012
NUVASIVE NVJJB SYSTEM
K112717 · ETN
Nuvasive, Inc.
Ear, Nose, Throat · 207d
Cleared Apr 02, 2012
A BAER WITH ABAER I/O FUNCTION
K112247 · EWO
Natus Medical Incorporated
Ear, Nose, Throat · 242d
Cleared Apr 02, 2012
XIAN FRIENDSHIP DISPOSABLE NERVE STIMULATOR PROBES
K112426 · ETN
Xian Friendship Medical Electronics...
Ear, Nose, Throat · 223d
Cleared Apr 02, 2012
PATHASSIT LIGHT SEEKER
K120735 · LRC
Entellus Medical, Inc.
Ear, Nose, Throat · 24d
Cleared Mar 16, 2012
NUVASIVE NVM5 SYSTEM
K112718 · ETN
Nuvasive, Inc.
Ear, Nose, Throat · 179d
Cleared Feb 09, 2012
STIMULATION/DISSECTION INSTRUMENTS
K112709 · ETN
Nu Vasive, Incorporated
Ear, Nose, Throat · 143d