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

865–888 of 3,812

Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat

Cleared Oct 16, 2003

EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND...

Olympus Optical Co., Ltd.

Ear, Nose, Throat · 10d

Cleared Sep 17, 2003

CRESCENT TINNITUS RETAINING SOUND GENERATOR

Starkey Laboratories, Inc.

Ear, Nose, Throat · 243d

Cleared Aug 12, 2003

AUDIOMETER, OTOACOUSTIC EMISSION, AUDITORY BRANSTEM RESPONSE ACCESS

Viasys Healthcare, Inc.

Ear, Nose, Throat · 71d

Cleared Aug 05, 2003

TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOSHEATH SYSTEM

Vision-Sciences, Inc.

Ear, Nose, Throat · 56d

Cleared Jul 24, 2003

Tinnitus Control, Inc.

Ear, Nose, Throat · 62d

Cleared Jul 24, 2003

VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V

Olympus Optical Co., Ltd.

Ear, Nose, Throat · 57d

Cleared Jul 24, 2003

ICS MEDICAL CHARTR EP WITH ASSR AND CHARTR OAE SYSTEMS

Ear, Nose, Throat · 27d

Cleared Jul 21, 2003

AMPLAID A756 SCREENING ADMITTANCE METER

Ear, Nose, Throat · 25d

Cleared Jul 16, 2003

BIO-LOGIC INSERT EARPHONES

Bio-Logic Systems Corp.

Ear, Nose, Throat · 78d

Cleared Jul 02, 2003

SLIDE-ON ENDOSHEATH SYSTEM FOR SENSORY TESTING

Vision-Sciences, Inc.

Ear, Nose, Throat · 22d

Cleared Jun 18, 2003

Medtronic Xomed

Ear, Nose, Throat · 35d

Cleared Apr 17, 2003

ANMP (ACOUSTIC NEURO MODULATION PROTOCOL)

Tinnitech, Ltd.

Ear, Nose, Throat · 36d

Cleared Apr 11, 2003

STIMULUS/DISSECTION INSTRUMENTS, BALL-TIP PROBES

Medtronic Xomed, Inc.

Ear, Nose, Throat · 11d

Cleared Apr 01, 2003

HENKE SASS WOLF OF AMERICA NASOPHARYNGOSCOPE

Henke Sass Wolf of America, Inc.

Ear, Nose, Throat · 36d

Cleared Mar 28, 2003

MUCUS COLLECTION PROBE, MODELS BC-401C & BC-402C

Aomori Olympus Co., Ltd.

Ear, Nose, Throat · 246d

Cleared Mar 28, 2003

Interacoustics A/S, Assens

Ear, Nose, Throat · 85d

Cleared Mar 07, 2003

AUDIOSCREENER OAE+ABR

Everest Biomedical Instruments Co.

Ear, Nose, Throat · 77d

Cleared Mar 03, 2003

TITANIUM OSSICULAR REPLACMENT SYSTEM

Invotec International, Inc.

Ear, Nose, Throat · 12d

Cleared Jan 31, 2003

MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160...

The Olympus Optical Co.

Ear, Nose, Throat · 60d

Cleared Jan 28, 2003

LFRE INDIRECT LARYNGOSCOPE

Astralite Corp.

Ear, Nose, Throat · 141d

Cleared Jan 28, 2003

SODEM HIGH SPEED SYSTEM (PNEUMATIC)

Ear, Nose, Throat · 134d

Cleared Jan 10, 2003

DUAL-LUMEN CATHETER

Ear, Nose, Throat · 24d

Cleared Jan 09, 2003

MODIFICATION TO VISION SCIENCES ENDOSHEATH SYSTEM

Vision-Sciences, Inc.

Ear, Nose, Throat · 28d

Cleared Jan 08, 2003

Intelligent Hearing Systems

Ear, Nose, Throat · 49d