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
3433–3456 of 3,823
Search insights Median review: 65d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Aug 31, 1981
CARL ZEISS INN MYRINGOTOMY TUBE LINE
K811698 · ETD
James L. Geraci & Associates, Inc.
Ear, Nose, Throat · 76d
Cleared Aug 21, 1981
ARGON MICROSURIGAL PROTOCOLS
K810740 · EWG
Lumenis, Inc.
Ear, Nose, Throat · 155d
Cleared Jul 28, 1981
MACHIDA NASOPHARYNGO-LARYNGOSCOPE
K811943 · EQN
Machida America, Inc.
Ear, Nose, Throat · 21d
Cleared Jul 28, 1981
EAGLE I HEARING AID
K811988 · ESD
Electone, Inc.
Ear, Nose, Throat · 15d
Cleared Jul 27, 1981
CUSTOM IN-THE-EAR HEARING AID
K811719 · ESD
Hearing Health Group, Inc.
Ear, Nose, Throat · 39d
Cleared Jul 27, 1981
SKIN STAPLE EXTRACTOR
K811887 · KBC
Sierra Laboratories, Inc.
Ear, Nose, Throat · 26d
Cleared Jul 15, 1981
PORTABLE AUDIOMETERS
K811727 · EWO
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 27d
Cleared Jul 15, 1981
FINETONE MODEL VI HEARING AID
K811751 · ESD
Vicon Instrument Co.
Ear, Nose, Throat · 23d
Cleared Jul 15, 1981
AUDITORY LOCALIZER
K811772 · ETS
Western Advanced Technology, Inc.
Ear, Nose, Throat · 23d
Cleared Jul 15, 1981
OCTOTOXIC SCREENER
K811790 · ETS
Western Advanced Technology, Inc.
Ear, Nose, Throat · 21d
Cleared Jul 01, 1981
TELESONIC & ARCON
K811031 · ESD
Telesonic, Inc.
Ear, Nose, Throat · 76d
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