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
3025–3048 of 3,823
Search insights Median review: 65d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Mar 28, 1985
POST-AURICULAR HEARING AID MODEL PE 600 PPC
K844859 · ESD
Phonic Ear, Inc.
Ear, Nose, Throat · 104d
Cleared Mar 28, 1985
POST-SURICULAR HEARING AID PE 600CD
K844863 · ESD
Phonic Ear, Inc.
Ear, Nose, Throat · 104d
Cleared Mar 27, 1985
POST-AURICULAR HEARING AID MODEL PE 600CHD
K844860 · ESD
Phonic Ear, Inc.
Ear, Nose, Throat · 103d
Cleared Mar 27, 1985
POST-AURICULAR HEARING AID MODEL PE 600PPCL
K844861 · ESD
Phonic Ear, Inc.
Ear, Nose, Throat · 103d
Cleared Mar 25, 1985
BODY HEARING AIDS MT 80 SP
K850185 · ESD
Robert Bosch Corp.
Ear, Nose, Throat · 66d
Cleared Mar 25, 1985
BOSCH STARR 66PP -HEARING AIDS
K850187 · ESD
Robert Bosch Corp.
Ear, Nose, Throat · 66d
Cleared Mar 25, 1985
BOSCH STAR 66PP-S HEARING AID
K850189 · ESD
Robert Bosch Corp.
Ear, Nose, Throat · 66d
Cleared Mar 25, 1985
STAR 66F-AGC-I HEARING AID
K850190 · ESD
Robert Bosch Corp.
Ear, Nose, Throat · 66d
Cleared Mar 25, 1985
HEARING AID 365
K850243 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 62d
Cleared Mar 25, 1985
AUTOMATIC IMPEDANCE METER TA-7A
K850461 · ETY
Teledyne Avionics Div. of Teledyne
Ear, Nose, Throat · 47d
Cleared Mar 25, 1985
EARETTE HEARING AID OTICON MODEL E32S
K850762 · ESD
Oticon Corp.
Ear, Nose, Throat · 28d
Cleared Mar 25, 1985
EARETTE HEARING AID OTICON E32U
K850763 · ESD
Oticon Corp.
Ear, Nose, Throat · 28d
Cleared Mar 21, 1985
IN-TH-EAR HEARING AID
K850123 · ESD
General Hearing Instruments, Inc.
Ear, Nose, Throat · 66d
Cleared Mar 07, 1985
NASAL SEPTAL BUTTON
K850492 · LFB
Santa Barbara Medco, Inc.
Ear, Nose, Throat · 27d
Cleared Mar 01, 1985
ACOUSTIC OTOCOPE RECORDER
K850007 · ETY
Endeco Medical, Inc.
Ear, Nose, Throat · 58d
Cleared Feb 26, 1985
INCUS PROSTHESIS
K844961 · ETB
Richards Medical Co., Inc.
Ear, Nose, Throat · 67d
Cleared Jan 29, 1985
JCM LABS CUSTOM PRESCRIPTION & ACCENT IN-THE-EAR
K844093 · ESD
Jcm Labs, Inc.
Ear, Nose, Throat · 99d
Cleared Jan 23, 1985
HEARING AID, UNITRON UE12-PPL
K843246 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 156d
Cleared Jan 23, 1985
MECON X (TEN)
K843484 · ESD
Mecon Labs
Ear, Nose, Throat · 139d
Cleared Jan 23, 1985
ADVANCED HEARING INSTRUMENTS - HEARING AIDS
K844728 · ESD
Advanced Hearing Instruments
Ear, Nose, Throat · 50d
Cleared Jan 23, 1985
IN THE EAR MODEL X-ITE 84
K844985 · ESD
Bernafon, Inc.
Ear, Nose, Throat · 28d
Cleared Jan 15, 1985
CONTINENT STOMA SYSTEM & ACCESSORIES
K844186 · KBG
Chesebrough-Pond'S U.S.A. Co.
Ear, Nose, Throat · 78d
Cleared Jan 10, 1985
HEARING AID, UNITRON UE12-PP
K843245 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 143d
Cleared Jan 09, 1985
BIOGLASS OSSICULAR RECONSTRUCTION PROSTH
K843461 · ETA
American Biomaterials Corp.
Ear, Nose, Throat · 126d