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
3025–3048 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
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
Cleared Jan 07, 1985
BEHIND THE EAR HEARING AID BERNAFON T-88P
K844621 · ESD
Bernafon, Inc.
Ear, Nose, Throat · 41d
Cleared Jan 07, 1985
MODEL 363C HEARING AID
K844648 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 39d
Cleared Jan 04, 1985
TYMPANOSTOMY TUBES-VARIOUS
K833246 · ETD
Abco Dealers, Inc.
Ear, Nose, Throat · 484d
Cleared Jan 04, 1985
BEHIND THE EAR HEARING AIDS BERNAFON X-13
K844425 · ESD
Bernafon, Inc.
Ear, Nose, Throat · 50d
Cleared Dec 13, 1984
ULTRA & ULTRA MINATURE
K843789 · ESD
Qualitone
Ear, Nose, Throat · 77d
Cleared Dec 11, 1984
HEARING AID - ALL IN THE EAR
K843574 · ESD
Auralogics Lab
Ear, Nose, Throat · 91d
Cleared Dec 04, 1984
MINUTEMAN CO2 MICROSURGICAL LASER OTO
K843514 · EWG
American Surgical Laser, Inc.
Ear, Nose, Throat · 90d
Cleared Dec 03, 1984
HEARING AIDS 372 & 372 AI
K843068 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 119d
Cleared Dec 03, 1984
AUDIOMETER
K843618 · EWO
Grason-Stadler, Inc.
Ear, Nose, Throat · 80d
Cleared Dec 03, 1984
RIONET HEARING AID HB-34AS
K844059 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 46d
Cleared Dec 03, 1984
TA-201 CLINICAL AUDIOMETER
K844069 · EWO
Teledyne Avionics Div. of Teledyne
Ear, Nose, Throat · 46d