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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Ear, Nose, Throat ×
3,798 results
1969–1992 of 3,798
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Jul 26, 1993
351-AGCO BEHIND-THE-EAR HEARING AID
K933095 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 32d
Cleared Jul 22, 1993
SYMBIOSIS ENT SURGICAL INSTRUMENTS
K931793 · LRC
Symbiosis Corp.
Ear, Nose, Throat · 101d
Cleared Jul 21, 1993
EAR CURETTE
K932609 · JYG
Ear Tech, Inc.
Ear, Nose, Throat · 54d
Cleared Jul 20, 1993
RESOUND PERSONAL HEARING SYSTEM BT-P W/PHS BT-P
K931942 · ESD
Resound Corp.
Ear, Nose, Throat · 92d
Cleared Jul 14, 1993
VINYL ADDITION SILICONE SYSTEM
K926150 · ESD
Crown Delta Corp.
Ear, Nose, Throat · 219d
Cleared Jul 14, 1993
BELTONE OPERA/OPERA MHP/OPERA MAX
K932426 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 56d
Cleared Jul 13, 1993
MILL-ROSE PULMONARY FORCEPS
K922204 · EOQ
Mill-Rose Laboratory
Ear, Nose, Throat · 428d
Cleared Jul 13, 1993
ACOUSTIC ANALYZER AA30
K930260 · EWO
Precision Acoustics Ind., Inc.
Ear, Nose, Throat · 175d
Cleared Jul 08, 1993
MODEL 322 CLINICAL AUDIOMETER
K930203 · EWD
Virtual Corp.
Ear, Nose, Throat · 175d
Cleared Jul 08, 1993
PHONAK LEXA 231X ITE SERIES HEARING SINSTRUMENT
K932175 · ESD
Phonak, Inc.
Ear, Nose, Throat · 64d
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