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
937–960 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Jul 03, 2001
HYALOMATRIX CO
K003855 · KHJ
Fidia Advanced Biopolymers Srl
Ear, Nose, Throat · 202d
Cleared Jul 03, 2001
ETYMOTIC RESEARCH ER-10D OAE PROBE
K011114 · EWO
Etymotic Research
Ear, Nose, Throat · 82d
Cleared Jun 26, 2001
MODIFICATION TO XPS 3000 SYSTEM
K011321 · ERL
Medtronic Xomed, Inc.
Ear, Nose, Throat · 60d
Cleared Jun 26, 2001
LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANT
K011554 · MIX
Biomet, Inc.
Ear, Nose, Throat · 39d
Cleared Jun 25, 2001
ICS MEDICAL CHARTR OAE WITH TYMP
K011181 · EWO
Ics Medical Corp.
Ear, Nose, Throat · 68d
Cleared Jun 25, 2001
MICRODOSE CATH, MODELS 90121-201, -202, -203
K011383 · ETD
Durect Corp.
Ear, Nose, Throat · 49d
Cleared Jun 07, 2001
CUSTOM TCI (TINNITUS CONTROL INSTRUMENT)
K011364 · KLW
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 34d
Cleared Jun 01, 2001
CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)
K011366 · KLW
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 28d
Cleared May 25, 2001
HUMMER IV MICRODEBRIDER SYSTEM
K011381 · ERL
Stryker Instruments
Ear, Nose, Throat · 18d
Cleared May 08, 2001
EXHALE RF PROBE
K011267 · EOQ
Broncus Technologies, Inc.
Ear, Nose, Throat · 12d
Cleared Apr 26, 2001
TCI (TINNITUS CONTROL INSTRUMENT)
K003559 · KLW
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 160d
Cleared Apr 24, 2001
TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)
K003558 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 158d
Cleared Apr 20, 2001
MODIFICATION TO CAVERMAP SURGICAL AID
K010213 · ETN
Uromed Corp.
Ear, Nose, Throat · 87d
Cleared Apr 13, 2001
LACTOSORB ETHMOID STENT
K002131 · LYA
Walter Lorenz Surgical, Inc.
Ear, Nose, Throat · 273d
Cleared Apr 13, 2001
KSEA UNIDRIVE II/II PLUS AND ENT ACCESSORIES
K003994 · ERL
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 108d
Cleared Apr 09, 2001
ENT ENDOSCOPES
K003830 · EOB
Global Endoscopy, Inc.
Ear, Nose, Throat · 119d
Cleared Mar 16, 2001
HINT AUDIOMETER, OR HINT
K003913 · EWO
Maico-Diagnostics
Ear, Nose, Throat · 87d
Cleared Mar 12, 2001
ERO SCAN OAE TEST SYSTEM
K010165 · EWO
Etymotic Research
Ear, Nose, Throat · 53d
Cleared Mar 08, 2001
KURZ ANGULAR PISTON-TITANIUM PROSTHESIS, MODELS 1006 600, 1006 601, 1006 602,...
K010442 · ETB
Heinz Kurz
Ear, Nose, Throat · 22d
Cleared Feb 12, 2001
SERENOCEM, MODEL BC 010
K003567 · NEA
Corinthian Medical , Ltd.
Ear, Nose, Throat · 84d
Cleared Jan 16, 2001
LARYNGEAL SURFACE ELECTRODE-ENDOTRACHEAL TUBE, M-500-ET, LSE-ET
K003745 · ETN
Rln Systems, Inc.
Ear, Nose, Throat · 43d
Cleared Dec 15, 2000
MEROGEL CONTROL GEL ENT SURGICAL DRESSING
K002972 · KHJ
Medtronic Xomed
Ear, Nose, Throat · 84d
Cleared Dec 04, 2000
XPS 3000 SYSTEM
K002224 · ERL
Medtronic Xomed
Ear, Nose, Throat · 133d
Cleared Nov 21, 2000
SINUSCOPE AND BACCESSORIES
K002214 · EOB
Pollux Endoscopy, Inc.
Ear, Nose, Throat · 120d