FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Ear, Nose, Throat ×
3,823 results
601–624 of 3,823
Search insights Median review: 65d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Nov 27, 2012
ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN
K122561 · KHJ
Ceremed , Inc.
Ear, Nose, Throat · 97d
Cleared Nov 05, 2012
RELIEVA SEEKER BALLOON SINUPLASTY SYSTEM
K120280 · LRC
Acclarent, Inc.
Ear, Nose, Throat · 280d
Cleared Nov 01, 2012
AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON
K121793 · LXB
Audifon-USA, Inc.
Ear, Nose, Throat · 135d
Cleared Nov 01, 2012
AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM
K122496 · EWO
Bio-Logic Systems Corp.
Ear, Nose, Throat · 77d
Cleared Oct 31, 2012
MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL
K122434 · NHB
Medtronic Xomed
Ear, Nose, Throat · 82d
Cleared Oct 31, 2012
MULTIFLEX TINNITUS TECHNOLOGY
K122876 · KLW
Starkey Laboratories
Ear, Nose, Throat · 42d
Cleared Oct 23, 2012
AURICAL HIT
K122028 · ETW
Gn Otometrics
Ear, Nose, Throat · 105d
Cleared Oct 19, 2012
NONDISPOSABLE STIMULATING INSTRUMENTS
K121931 · ETN
Neurovision Medical Products, Inc.
Ear, Nose, Throat · 109d
Cleared Oct 12, 2012
COCHLEAR BAHA IMPLANT SYSTEM
K121317 · MAH
Cochlear Americas
Ear, Nose, Throat · 163d
Cleared Sep 20, 2012
VESTIBULAR ANALYSIS APPARATUS
K121590 · LXV
Capacity Sports, LLC
Ear, Nose, Throat · 112d
Cleared Sep 07, 2012
PONTO BONE ANCHORED HEARING SYSTEM
K121228 · MAH
Oticon Medical AB
Ear, Nose, Throat · 137d
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