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
3457–3480 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Apr 14, 1981
EXMOOR AURAL GROMMET AG/T3
K810704 · ETD
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 29d
Cleared Apr 14, 1981
EXMOOR AURAL GROMMET AG/T4
K810705 · ETD
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 29d
Cleared Apr 14, 1981
EXMOOR AURAL GROMMET AG/T5
K810706 · ETD
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 29d
Cleared Mar 31, 1981
BOSCH STAR 66F SUPER EARLEVEL AID
K810347 · ESD
Bosch Hearing Instruments, Inc.
Ear, Nose, Throat · 49d
Cleared Mar 31, 1981
POWER SONIC
K810577 · ESD
Qualitone
Ear, Nose, Throat · 28d
Cleared Mar 31, 1981
GOODE MAGNETIC NASAL SPLINT
K810738 · EPP
Xomed, Inc.
Ear, Nose, Throat · 13d
Cleared Mar 20, 1981
AUTO SUTURE PSS SKIN STAPLING INSTRUMENT
K810187 · KBC
United States Surgical, A Division of...
Ear, Nose, Throat · 57d
Cleared Mar 20, 1981
AUTO SUTURE GAS POWERED DISP. LDS STAPL
K810188 · KBC
United States Surgical, A Division of...
Ear, Nose, Throat · 57d
Cleared Mar 20, 1981
EARETTE HEARING AID OTICON #E27
K810610 · ESD
Oticon Corp.
Ear, Nose, Throat · 14d
Cleared Mar 17, 1981
EARETTE HEARING AID(BEHING THE EAR)
K810576 · ESD
Oticon Corp.
Ear, Nose, Throat · 14d
Cleared Mar 11, 1981
AUTOMATIC TEFLON INJECTION SYRINGE
K810284 · KCP
R. Wolf Medical Instruments Corp.
Ear, Nose, Throat · 37d
Cleared Mar 11, 1981
AUTOMATIC SCREENING AUDIOMETER
K810537 · EWO
Positron
Ear, Nose, Throat · 13d
Cleared Mar 04, 1981
STEREO AUDITORY TRAINER (MODEL PM228)
K810031 · EPF
Hc Electronics
Ear, Nose, Throat · 57d
Cleared Mar 04, 1981
EARETTE HEARING AID SEARS MODEL 8053
K810389 · ESD
Oticon Corp.
Ear, Nose, Throat · 15d
Cleared Feb 17, 1981
ATMOSET
K810148 · ETF
Jedmed Instrument Co.
Ear, Nose, Throat · 27d
Cleared Feb 05, 1981
PANJE VOICE PROSTHESIS
K810020 · EWL
Xomed, Inc.
Ear, Nose, Throat · 31d
Cleared Jan 14, 1981
POST-AURICULAR HEARING AID (#PE830)
K810030 · ESD
Hc Electronics
Ear, Nose, Throat · 8d
Cleared Dec 31, 1980
NUVOX BEDSIDE TINNITUS MASKER
K802750 · KLW
Hal-Hen Co., Inc.
Ear, Nose, Throat · 57d
Cleared Dec 31, 1980
BEHIND-THE-EAR HEARING AID
K802859 · ESD
Danavox, Inc.
Ear, Nose, Throat · 49d
Cleared Dec 30, 1980
HIGH FREQUENCY AUDIOMETER DELMAR #20-K
K803072 · EWO
Demlar Medical, Inc.
Ear, Nose, Throat · 25d
Cleared Dec 19, 1980
SHEA LOCKING BAIL PROSTHESIS
K802873 · ETB
Richard'S Medical Equip., Inc.
Ear, Nose, Throat · 35d
Cleared Dec 19, 1980
MONTG. TRACHEAL TREPHINE FENE STRATOR
K802915 · KBF
Boston Medical Products, Inc.
Ear, Nose, Throat · 30d
Cleared Dec 19, 1980
101, 151, 161 PORTABLE AUDIOMETERS
K802963 · EWO
Amplaid USA, Inc.
Ear, Nose, Throat · 28d
Cleared Dec 17, 1980
RION ELECTRO-PALATOGRAPH MODEL DP-01
K802870 · LEZ
Kindel & Anderson
Ear, Nose, Throat · 33d