FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Ear, Nose, Throat ×
3,823 results
3457–3480 of 3,823
Search insights Median review: 65d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared May 27, 1981
PENTAX BRONCHOFIBERSCOPE #FB-15A
K811059 · EOQ
Pentax Precision Instrument Corp.
Ear, Nose, Throat · 40d
Cleared May 27, 1981
OMNI
K811158 · ESD
Omni Hearing Systems
Ear, Nose, Throat · 29d
Cleared May 13, 1981
HEARING AID, UNITRON MODEL C5-H
K811174 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 15d
Cleared May 13, 1981
MODEL FBS-1, FLEXIBLE BRONCHOSCOPE
K811181 · EOQ
American Optical Corp.
Ear, Nose, Throat · 15d
Cleared May 13, 1981
DAHLBERG MODEL AM
K811226 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 9d
Cleared May 05, 1981
EARETTE HEARING AID OTICON #E25F
K810986 · ESD
Oticon Corp.
Ear, Nose, Throat · 19d
Cleared May 05, 1981
EARETTE HEARING AID OTICON #E27F
K810987 · ESD
Oticon Corp.
Ear, Nose, Throat · 22d
Cleared Apr 29, 1981
AUDIOMETER
K810583 · EWO
Grason-Stadler, Inc.
Ear, Nose, Throat · 57d
Cleared Apr 14, 1981
EXMOOR AURAL GROMMET
K810701 · ETD
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 29d
Cleared Apr 14, 1981
EXMOOR AURAL GROMMET AG/T2L
K810702 · ETD
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 29d
Cleared Apr 14, 1981
EXMOOR AURAL GROMMET AG/T2
K810703 · ETD
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 29d
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