FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Ear, Nose, Throat ×
3,805 results
3433–3456 of 3,805
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Jun 16, 1981
HEARING AID MODEL E1-P
K811285 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 39d
Cleared Jun 16, 1981
HEARING AID MODEL E1-PL
K811286 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 39d
Cleared Jun 16, 1981
BEHIND-THE-EAR HEARING AID
K811344 · ESD
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 35d
Cleared Jun 16, 1981
NORTHWESTERN VOICE RESTORATION KIT
K811428 · KAC
Universal Prosthetics, Inc.
Ear, Nose, Throat · 25d
Cleared Jun 16, 1981
GOTTSCHALK NASOSTAT SLIM LINE, ADULT/SM.
K811496 · EMX
Narco Scientific
Ear, Nose, Throat · 20d
Cleared Jun 16, 1981
AUTO-TYMPANIGRAPH (TA-5A)
K811509 · ETY
Teledyne Avionics Div. of Teledyne
Ear, Nose, Throat · 20d
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