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
793–816 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Aug 18, 2006
RELIEVA SINUS BALLOON CATHETER
K061903 · LRC
Acclarent, Inc.
Ear, Nose, Throat · 44d
Cleared Jul 12, 2006
NEOZOLINE VENTILATION TUBES
K061058 · ETD
Adept Medical, Ltd.
Ear, Nose, Throat · 86d
Cleared Jul 12, 2006
CHECKPOINT WITH ACCUSTIM TECHNOLOGY
K061365 · ETN
Ndi Medical, LLC
Ear, Nose, Throat · 57d
Cleared Jun 30, 2006
TRANQUIL TRI-BTE
K061459 · KLW
General Hearing Instruments, Inc.
Ear, Nose, Throat · 35d
Cleared Jun 28, 2006
PARTIAL OSSICULAR REPLACEMENT PROSTHESES
K060518 · ETB
Grace Medical, Inc.
Ear, Nose, Throat · 121d
Cleared Jun 23, 2006
OLYMPUS GUIDE SHEATH, MODEL XBO1-836-13
K060243 · EOQ
Olympus Medical Systems Corporation
Ear, Nose, Throat · 143d
Cleared Jun 23, 2006
PILOT TEST OR DETECTIVE AUDIOMETERS
K060883 · EWO
Interacoustics A/S
Ear, Nose, Throat · 84d
Cleared Jun 05, 2006
MODEL MI 44 TYMPANOMETER
K060885 · EWO
Maico-Diagnostics
Ear, Nose, Throat · 66d
Cleared May 30, 2006
DPOAE20 , ECLIPSE
K060539 · EWO
Interacoustics A/S, Assens
Ear, Nose, Throat · 90d
Cleared May 30, 2006
CLEARADEX GEL
K060561 · KHJ
Cambridgemed
Ear, Nose, Throat · 88d
Cleared May 16, 2006
TINNITUS PHASE-OUT
K061111 · KLW
Tinnitus Control, Inc.
Ear, Nose, Throat · 25d
Cleared May 03, 2006
SPEECHLINK 100 TYPE 1053
K061104 · ETW
Gn Otometrics A/S
Ear, Nose, Throat · 13d
Cleared Apr 19, 2006
STRYKER INJECTABLE CEMENT
K060750 · NEA
Stryker Cmf
Ear, Nose, Throat · 29d
Cleared Apr 18, 2006
JULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANT
K060815 · MIX
Bioform Medical, Inc.
Ear, Nose, Throat · 22d
Cleared Apr 13, 2006
GELITA-SPON ABSORBABLE GELATIN SPONGE, USP
K060878 · KHJ
Curamedical, BV
Ear, Nose, Throat · 13d
Not Cleared Mar 27, 2006
HEALTHCHECK(TM) HOME TEST FOR LOSS OF THE SENSE OF SMELL
DEN050007 · NRK
Fmg Innovations, Inc.
Ear, Nose, Throat · 280d
Cleared Feb 22, 2006
NASALGUARD
K053625 · NUP
Trutek Corp
Ear, Nose, Throat · 56d
Cleared Feb 10, 2006
HEARID WIDEBAND MIDDLE EAR POWER ANALYZER
K053216 · EWO
Mimosa Acoustics, Inc.
Ear, Nose, Throat · 85d
Cleared Dec 23, 2005
ECLIPSE (CABINET NAME), TEOAE25, EP15, OR THE COMBINATION OF SYSTEMS.
K052562 · EWO
Interacoustics AS
Ear, Nose, Throat · 95d
Cleared Dec 22, 2005
DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE
K051487 · KHJ
Doctor'S Research Group, Inc.
Ear, Nose, Throat · 199d
Cleared Dec 19, 2005
KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES
K053262 · ERL
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 27d
Cleared Dec 14, 2005
NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800
K053141 · ETN
The Magstim Company , Ltd.
Ear, Nose, Throat · 35d
Cleared Dec 06, 2005
GELITA-SPON
K051911 · KHJ
Curamedical, BV
Ear, Nose, Throat · 145d
Cleared Nov 21, 2005
NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ
K052099 · LYA
Polyganics B.V.,
Ear, Nose, Throat · 110d