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
1993–2016 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Jul 02, 1993
INSTANT IN-DWELL NASAL SUCT TAMP/ALLEVIA NASAL TRA
K924944 · EMX
Westmed Intl.
Ear, Nose, Throat · 275d
Cleared Jul 02, 1993
IN THE CANAL AID OTOSONIC ACS II WITH SRR
K931881 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 79d
Cleared Jul 02, 1993
BELTONE OPTIMA 2000 ITE HEARING AID
K932058 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 65d
Cleared Jun 24, 1993
M30 IN THE EAR HEARING AID
K922501 · ESD
Electone, Inc.
Ear, Nose, Throat · 393d
Cleared Jun 24, 1993
M32 IN THE EAR HEARING AID
K922502 · ESD
Electone, Inc.
Ear, Nose, Throat · 393d
Cleared Jun 22, 1993
NCA-200
K931608 · KHH
Ics Medical Corp.
Ear, Nose, Throat · 82d
Cleared Jun 22, 1993
AUDIOTECH MODEL DP
K931975 · ESD
Muskogee Regional Hearing Aid Lab
Ear, Nose, Throat · 61d
Cleared Jun 18, 1993
TUBEPHONE MODELS ER-3A & ER-3 INSERT EARPHONES
K930003 · EWO
Etymotic Research
Ear, Nose, Throat · 165d
Cleared Jun 14, 1993
MICRO MASKER
K924991 · KLW
Associated Hearing Instruments
Ear, Nose, Throat · 256d
Cleared Jun 14, 1993
HEARING AIDS
K932105 · ESD
Katz Hearing Aid Center
Ear, Nose, Throat · 42d
Cleared Jun 14, 1993
IN-THE-EAR HEARING AID
K932189 · ESD
Lifestyle Hearing, Inc.
Ear, Nose, Throat · 39d
Cleared Jun 08, 1993
PERFECT EAR/PE
K931984 · ESD
Perfect Ear
Ear, Nose, Throat · 47d
Cleared Jun 01, 1993
WILTEK BIOPSY FORCEPS
K930419 · BWH
Wiltek Medical, Inc.
Ear, Nose, Throat · 126d
Cleared Jun 01, 1993
MODELS 33PP, 33PP ANR, & 33PP SUPER HEARING AID
K931035 · ESD
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 92d
Cleared Jun 01, 1993
MT 80 SP
K931040 · ESD
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 92d
Cleared Jun 01, 1993
STAR 42 PP-SP, STAR 42 PP-SL (T100)
K931041 · ESD
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 92d
Cleared Jun 01, 1993
SERIES STAR 66 BEKHIND THE EAR HEARING AID
K931160 · ESD
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 85d
Cleared Jun 01, 1993
SERIES STAR 22 - BEHIND THE EAR HEARING AID
K931161 · ESD
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 85d
Cleared May 19, 1993
ITE MODEL ADOBE 100 FULL CUSTOM
K931590 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 49d
Cleared May 19, 1993
ITC MODEL ADOBE 100 CANAL
K931591 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 49d
Cleared May 18, 1993
VENTILATION TUBES W/ HYDROGEL COATING
K923353 · ETD
Microbio-Medics, Inc.
Ear, Nose, Throat · 314d
Cleared May 17, 1993
BLOM-SINGER LOW PRESSURE VOICE PROSTHESIS,P.I.D.S.
K930105 · EWL
Helix Medical, Inc.
Ear, Nose, Throat · 126d
Cleared May 17, 1993
NASAL/PARANASAL ENDOSCOPE
K930931 · EOB
Storz Instrument Co.
Ear, Nose, Throat · 83d
Cleared May 05, 1993
AUTOMATIC CALORIC IRRIGATION SYSTEM
K925237 · KHH
Ics Medical Corp.
Ear, Nose, Throat · 201d