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
3433–3456 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Jul 01, 1981
ACMI ASPIRATOR KIT #8808
K811218 · EOQ
American Cystocope Makers, Inc.
Ear, Nose, Throat · 58d
Cleared Jul 01, 1981
DAHLBERG MODEL AP HEARING AID
K811578 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 26d
Cleared Jun 26, 1981
RE-HP SERIES HEARING AIDS
K811522 · ESD
Radioear Corp.
Ear, Nose, Throat · 28d
Cleared Jun 26, 1981
RIONET HEARING AID HB-69S
K811529 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 25d
Cleared Jun 26, 1981
RIONET HEARING AID HB 69 T
K811530 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 25d
Cleared Jun 26, 1981
RIONET HEARING AID HB-69
K811531 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 25d
Cleared Jun 16, 1981
CERAVITAL CERAMIC OSSICULAR REPL. PROS.
K810707 · ETA
Xomed, Inc.
Ear, Nose, Throat · 92d
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