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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Ear, Nose, Throat ×
3,805 results
3025–3048 of 3,805
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
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
Cleared Dec 03, 1984
STARKET MODEL HMS
K844275 · ETW
Starkey Laboratories, Inc.
Ear, Nose, Throat · 28d
Cleared Nov 16, 1984
PERSONAL AMPLIFIER SILENCER
K843980 · ESD
Electone, Inc.
Ear, Nose, Throat · 36d
Cleared Nov 14, 1984
KANIEVSKI SENSORY AID OR DEVICE
K843433 · LRA
Spectro Industries, Inc.
Ear, Nose, Throat · 71d
Cleared Nov 09, 1984
A.S.P.C./CLEARSOUND
K842832 · ESD
Asl, Inc.
Ear, Nose, Throat · 112d
Cleared Nov 09, 1984
BEHIND-THE-EAR 123 VTH
K843791 · ESD
Danavox, Inc.
Ear, Nose, Throat · 43d
Cleared Nov 09, 1984
RIONET HEARING AID HB-73
K844000 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 28d
Cleared Nov 09, 1984
VOLUMATIC
K844169 · KCD
Glaxo, Inc.
Ear, Nose, Throat · 15d