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
745–768 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Apr 02, 2008
ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105
K080622 · EOB
Optim, Inc.
Ear, Nose, Throat · 28d
Cleared Mar 24, 2008
XPS 3000 SYSTEM
K073255 · ERL
Medtronic Xomed, Inc.
Ear, Nose, Throat · 126d
Cleared Mar 14, 2008
EARPOPPER, MODEL EP-2000, EP-2100, EP-3000
K073401 · MJV
Micromedics, Inc.
Ear, Nose, Throat · 101d
Cleared Mar 13, 2008
TINNITUS SOUND GENERATOR MODULE
K073636 · KLW
Gn Resound A/S
Ear, Nose, Throat · 78d
Cleared Feb 28, 2008
ENVOYCEM, MODEL 1640
K080032 · NEA
Envoy Medical Corporation
Ear, Nose, Throat · 52d
Cleared Feb 15, 2008
VF GEL PLUS
K071663 · MIX
Coapt Systems, Inc.
Ear, Nose, Throat · 242d
Cleared Jan 22, 2008
RHYTHMLINK INTERNATIONAL MONOPOLAR STIMULATING INSTRUMENT
K072736 · ETN
Rhythmlink International, LLC
Ear, Nose, Throat · 117d
Cleared Dec 12, 2007
TROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODEL 1015 074, 1015...
K071150 · ETD
Heinz Kurz GmbH Medizintechnik
Ear, Nose, Throat · 231d
Cleared Dec 12, 2007
NEUROSIGN LARYNGEAL ELECTRODES
K071349 · ETN
The Magstim Company , Ltd.
Ear, Nose, Throat · 212d
Cleared Nov 13, 2007
OTODYNAMICS OTOPORT
K072033 · EWO
Otodynamics, Ltd.
Ear, Nose, Throat · 112d
Cleared Sep 13, 2007
KARL STORZ VIDEO RHINO-LARYNGSCOPE SYSTEM, MODEL 11101 SERIES
K072387 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 20d
Cleared Aug 29, 2007
VISION-SCIENCES ENT-5000 AND ENT-5100 VIDEO ENT SCOPE WITH ENDOSHEATH SYSTEM,...
K072073 · EOB
Vision-Sciences, Inc.
Ear, Nose, Throat · 30d
Cleared Aug 29, 2007
FLEXIBLE TRANS-NASAL VIDEO ESOPHAGOSCOPE WITH DIGITAL VIDEO PROCESSOR AND...
K072088 · EOX
Vision-Sciences, Inc.
Ear, Nose, Throat · 30d
Cleared Aug 24, 2007
KARL STORZ VIDEO FLEXIBLE VIDEO ENT ENDOSCOPE SYSTEM
K071530 · EOQ
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 80d
Cleared Aug 02, 2007
ENDOSHEATH SYSTEMS FOR USE WITH VISION-SCIENCES TNE SCOPE
K071903 · EOX
Vision-Sciences, Inc.
Ear, Nose, Throat · 23d
Cleared Jul 13, 2007
CUSTOMIZED SOUND THERAPY (CST)
K070599 · KLW
Tinnitus Otosound Products, LLC
Ear, Nose, Throat · 133d
Cleared Jun 29, 2007
THE INHIBITOR, MODEL 001
K070648 · KLW
Melmedtronics, Inc.
Ear, Nose, Throat · 113d
Cleared Jun 22, 2007
OTOMEDICS SOFT TYMPANOSTOMY TUBE
K071178 · ETD
Otomedics Advanced Medical...
Ear, Nose, Throat · 56d
Cleared Jun 13, 2007
NASOPHARYNGOSCOPE, BRONCHOSCOPE
K070580 · EOB
Xion GmbH
Ear, Nose, Throat · 104d
Cleared Jun 07, 2007
ER35 ERO-SCAN PRO HEARING TEST SYSTEM
K070880 · EWO
Etymotic Research, Inc.
Ear, Nose, Throat · 69d
Cleared Jun 05, 2007
UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)
K071462 · ETW
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 11d
Cleared May 07, 2007
NASOPORE EAR
K070715 · NHB
Polyganics B.V.,
Ear, Nose, Throat · 54d
Cleared May 01, 2007
KSEA MINIATURE ENDOSCOPE, MODEL 11565
K070752 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 43d
Cleared Apr 26, 2007
MEROGEL INJECTABLE BIORESORBABLE STENT
K070886 · NHB
Medtronic, Inc.
Ear, Nose, Throat · 27d