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
1945–1968 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Sep 29, 1993
CUB DIS OTOACOUSTIC EMISSIONS TEST INSTRUMENT
K930553 · EWO
Etymotic Research
Ear, Nose, Throat · 238d
Cleared Sep 18, 1993
AS-90
K923006 · ESD
Qualitone
Ear, Nose, Throat · 453d
Cleared Sep 07, 1993
FIBEROPTIC LIGHTSOURCES AND CARRIERS
K933145 · EQH
Electro Fiberoptics Corp.
Ear, Nose, Throat · 71d
Cleared Sep 07, 1993
PHILIPS 45 SERIES
K933850 · ESD
Philips Hearing Instruments Co.
Ear, Nose, Throat · 32d
Cleared Aug 30, 1993
GM SWIVEL VIDEO (TM) IRRIGATOR
K931398 · KAR
Gm Engineering, Inc.
Ear, Nose, Throat · 164d
Cleared Aug 25, 1993
DENRICK SPEECH AID (DR-1)
K931371 · ESE
Denrick Corp.
Ear, Nose, Throat · 161d
Cleared Aug 25, 1993
LANGGASSE 90
K932470 · ETF
Happersberger Otopront GmbH
Ear, Nose, Throat · 97d
Cleared Aug 23, 1993
MAICO BTE MODEL RD-111 AND ITE MODEL RD-312 HEARING AID
K933291 · ESD
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 48d
Cleared Aug 23, 1993
MULTIFOCUS COMPACT BTE HEARING AID
K933307 · ESD
Oticon, Inc.
Ear, Nose, Throat · 47d
Cleared Aug 23, 1993
MEMOREX ARTISAN SYSTEM/ARTISAN PROGRAMMER AND CUSTOM HEARING AID
K933579 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 31d
Cleared Aug 23, 1993
WIDEX MODEL LOGO 12 (L12)
K933640 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 27d
Cleared Aug 23, 1993
WIDEX MODEL LOGO 6 (L6)
K933643 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 27d
Cleared Aug 23, 1993
WIDEX MODEL LOGO 8 (L8)
K933644 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 27d
Cleared Aug 19, 1993
BELTONE PRIMA 2000
K932703 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 77d
Cleared Aug 17, 1993
XOMED-TREACE EMG ENDOTRACHEAL TUBEEN
K925640 · ETN
Xomed-Treace, Inc.
Ear, Nose, Throat · 281d
Cleared Aug 17, 1993
MEROCEL MEROSPLINT
K933152 · LYA
Merocel Corp.
Ear, Nose, Throat · 49d
Cleared Aug 09, 1993
PRIZM HEARING SYSTEM
K930909 · ESD
Audioscience, Inc.
Ear, Nose, Throat · 180d
Cleared Aug 05, 1993
MA25 - PORTABLE AUDIOMETER, MODIFICATION
K926439 · EWO
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 225d
Cleared Aug 05, 1993
MAICO MA790 AUDIOMETER
K930112 · EWO
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 206d
Cleared Aug 05, 1993
OTICON MF
K932670 · ESD
Oticon Corp.
Ear, Nose, Throat · 64d
Cleared Aug 03, 1993
OTOSCOPE
K925758 · ERA
Rudolf Riester GmbH & Co. KG
Ear, Nose, Throat · 263d
Cleared Aug 02, 1993
GOLD ASP MODULE, ITE
K933036 · ESD
Electone, Inc.
Ear, Nose, Throat · 96d
Cleared Aug 02, 1993
GOLD K AMP, ITE
K933037 · LRB
Electone, Inc.
Ear, Nose, Throat · 96d
Cleared Aug 02, 1993
GOLD AF MODULE, ITE
K933038 · LRB
Electone, Inc.
Ear, Nose, Throat · 96d