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
841–864 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Aug 26, 2004
BAHA DIVINO
K042017 · LXB
Entific Medical Systems, Inc.
Ear, Nose, Throat · 30d
Cleared Aug 20, 2004
RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION...
K040996 · NIX
Gyrus Ent LLC
Ear, Nose, Throat · 126d
Cleared Aug 12, 2004
XPS CURVED BUR
K041985 · EQJ
Medtronic Xomed, Inc.
Ear, Nose, Throat · 20d
Cleared Jul 23, 2004
XPS 3000 SYSTEM
K041523 · ERL
Medtronic Xomed, Inc.
Ear, Nose, Throat · 45d
Cleared Jul 12, 2004
XPS 3000 SYSTEM
K041413 · ERL
Medtronic Xomed, Inc.
Ear, Nose, Throat · 46d
Cleared Jul 01, 2004
REFUGE SOUND GENERATOR
K041302 · KLW
Micro-Ear Technology, Inc.
Ear, Nose, Throat · 48d
Cleared Jul 01, 2004
NASALCEASE
K041446 · EMX
Les Laboratorires Brothier, S.A.
Ear, Nose, Throat · 30d
Cleared Apr 30, 2004
SONA PILLOW
K040161 · MYB
Sleep Devices, Inc.
Ear, Nose, Throat · 98d
Cleared Apr 27, 2004
VISION SCIENCES MODEL ENT-2000V FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE
K040984 · EOB
Vision-Sciences, Inc.
Ear, Nose, Throat · 12d
Cleared Apr 19, 2004
BRONCHOVIDEOSCOPE OLYMPUS XBF-D160HM
K040940 · EOQ
Olympus Corporation
Ear, Nose, Throat · 7d
Cleared Apr 12, 2004
QUIESCENCE
K040330 · KLW
Spectral Visualization & Development,...
Ear, Nose, Throat · 61d
Cleared Apr 01, 2004
NUVASIVE NEUROVISION JJB SYSTEM
K040543 · ETN
Nuvasive, Inc.
Ear, Nose, Throat · 30d
Cleared Mar 31, 2004
OTOFLEX 100 TYE 1012
K033645 · ETY
Gn Otometrics A/S
Ear, Nose, Throat · 132d
Cleared Mar 03, 2004
DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE
K034004 · ERL
Gyrus Ent LLC
Ear, Nose, Throat · 70d
Cleared Mar 03, 2004
STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE)
K040300 · ERL
Stryker Instruments
Ear, Nose, Throat · 23d
Cleared Jan 30, 2004
KURZ SILICONE STRIPS, MODELS SF-1, SF-1W, SF-1 BS
K033796 · KHJ
Heinz Kurz GmbH Medizintechnik
Ear, Nose, Throat · 56d
Cleared Jan 20, 2004
EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412
K040018 · EOQ
Boston Scientific Corp
Ear, Nose, Throat · 14d
Cleared Jan 08, 2004
ASAP SINUSCOPE...
K032822 · EOB
Asap Endoscopic Products GmbH
Ear, Nose, Throat · 120d
Cleared Dec 12, 2003
LARYNGEAL AUGMENTATION IMPLANT
K033398 · MIX
Bioform, Inc.
Ear, Nose, Throat · 49d
Cleared Nov 24, 2003
SMART OFFSET STAPES PISTON
K033554 · ETB
Gyrus Ent LLC
Ear, Nose, Throat · 12d
Cleared Oct 27, 2003
VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER
K033108 · EWO
Vivosonic, Inc.
Ear, Nose, Throat · 27d
Cleared Oct 24, 2003
NUVASIVE NEUROVISION JJB SYSTEM
K032083 · ETN
Nuvasive, Inc.
Ear, Nose, Throat · 109d
Cleared Oct 16, 2003
MAHE PEDIATRIC NASO PHARYNGOSCOPE ITS ASSOCIATED AND ANCILLARY EQUIPMENT AND...
K030857 · EOB
Mahe Intl., Inc.
Ear, Nose, Throat · 212d
Cleared Oct 16, 2003
ENK FIBEROPTIC ATOMIZER SET
K031966 · EOQ
Cook, Inc.
Ear, Nose, Throat · 112d