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
1249–1272 of 3,798
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Jan 24, 1997
COMFORTAID HEARING AID
K964680 · ESD
Ethical Hearing Instruments
Ear, Nose, Throat · 63d
Cleared Jan 24, 1997
M11 SERIES: M11, M11M
K965088 · ESD
Philips Hearing Instruments Co.
Ear, Nose, Throat · 36d
Cleared Jan 24, 1997
SENSO DIGITAL (C18)
K965218 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 25d
Cleared Jan 22, 1997
RICHARDS TOTAL/PARTIAL PROSTHESIS
K962564 · ETB
Gyrus Ent LLC
Ear, Nose, Throat · 205d
Cleared Jan 21, 1997
TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-II
K964639 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 63d
Cleared Jan 17, 1997
APEX UNIVERSAL DRIVE SYSTEM
K964548 · ERL
Linvatec Corp.
Ear, Nose, Throat · 65d
Cleared Jan 17, 1997
AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EAR
K964816 · ESD
Audina Hearing Instrument
Ear, Nose, Throat · 49d
Cleared Jan 10, 1997
ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PC
K962995 · EWO
Otodynamics, Ltd.
Ear, Nose, Throat · 162d
Cleared Jan 10, 1997
PORTAREM-3000, PFS-6000
K964340 · EWO
Starkey Laboratories, Inc.
Ear, Nose, Throat · 71d
Cleared Jan 10, 1997
ANSPACH MICROMAX SYSTEM
K965080 · ERL
The Anspach Effort, Inc.
Ear, Nose, Throat · 22d
Cleared Jan 08, 1997
LORI HEARING AID SIMULATOR
K964080 · KHL
Lori Medical Laboratories, Inc.
Ear, Nose, Throat · 89d
Cleared Jan 02, 1997
PARTIAL OSSICULAR REPLACEMENT PROSTHESIS
K964798 · ETB
Anthony D. Prescott
Ear, Nose, Throat · 34d
Cleared Dec 26, 1996
MIRACLE-EAR OR AUDIOTONE
K964669 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 35d
Cleared Dec 23, 1996
VISION-SCIENCES MODEL B-F100 BRONCHOSCOPE WITH MODEL BS-F21 DISPOSABLE...
K963795 · EOQ
Vision-Sciences, Inc.
Ear, Nose, Throat · 91d
Cleared Dec 23, 1996
DAHLBERG K-AMP BTE
K964794 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 24d
Cleared Dec 12, 1996
DIGIFOCUS ITE
K964683 · ESD
Oticon, Inc.
Ear, Nose, Throat · 20d
Cleared Dec 06, 1996
AHS OMEGA CONCEPT
K963877 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 71d
Cleared Dec 06, 1996
AHS OMEGA HF
K963878 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 71d
Cleared Dec 06, 1996
STARKEY TM-3, TM-5 HIGH FREQUENCY TINNITUS MASKER
K964216 · KLW
Starkey Laboratories, Inc.
Ear, Nose, Throat · 45d
Cleared Dec 06, 1996
ARTICULAR HEARING AIDS
K964603 · ESD
Decibel Instruments, Inc.
Ear, Nose, Throat · 18d
Cleared Dec 05, 1996
IMPRESS, PERFECTA, ACU-FORM, AND ACUFIT
K963958 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 64d
Cleared Dec 04, 1996
PHONAK MICROLINK, PERSONAL FM RECEIVER
K964035 · ESD
Phonak, Inc.
Ear, Nose, Throat · 57d
Cleared Nov 27, 1996
GALILEO ENDOSCOPES
K962116 · EOB
Galileo Electro-Optics Corp.
Ear, Nose, Throat · 180d
Cleared Nov 27, 1996
PRIMOFOCUS COMPACT
K963788 · ESD
Oticon Corp.
Ear, Nose, Throat · 68d