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
1561–1584 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared May 25, 1995
AUDIOTECH MODEL SPI
K950963 · ESD
Muskogee Regional Hearing Aid Lab
Ear, Nose, Throat · 84d
Cleared May 25, 1995
SIEMENS PC AUIDIOMETER MODEL SD 100 & PC PROBE MIC SYSTEM MODEL SD 110/SD...
K952098 · ETW
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 21d
Cleared May 24, 1995
SINUSCOPE
K940317 · EOB
Stephen Chakoff, Inc.
Ear, Nose, Throat · 485d
Cleared May 24, 1995
RIONET HM-02
K943808 · ESD
Rockwin Corp.
Ear, Nose, Throat · 293d
Cleared May 24, 1995
EARCLEAR
K951596 · MJV
Arisil Medical
Ear, Nose, Throat · 47d
Cleared May 15, 1995
THE MODEL ACAPPELLA IN THE EAR HEARING AID
K943961 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 273d
Cleared May 15, 1995
KARL STORZ TRACHEAL HIGH FREQUENCY RESECTOSCOPE
K951826 · EOQ
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 25d
Cleared May 12, 1995
DISPOSABLE AUDIOMETER EARPHONE CUSHION COVER
K943215 · EWO
Kenneth Ullrich
Ear, Nose, Throat · 311d
Cleared May 12, 1995
PERFECT, ENT SET, PRAKTIKANT, DE LUXE
K950913 · ERA
Rudolf Riester GmbH & Co. KG
Ear, Nose, Throat · 78d
Cleared May 12, 1995
RESOUND ED4-C CANAL PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION (RESOUND...
K951067 · ESD
Resound Corp.
Ear, Nose, Throat · 65d
Cleared May 12, 1995
RESOUND ED4-M MINI-CANAL PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION...
K951068 · ESD
Resound Corp.
Ear, Nose, Throat · 65d
Cleared May 12, 1995
TREBAY IRRGATED CUTTER BLADE
K951526 · EQJ
Trebay Medical Corp.
Ear, Nose, Throat · 39d
Cleared May 09, 1995
KARL STORZ ENT NEEDLES, TONSIL SYRINGES & NEEDLES
K951395 · EOX
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 42d
Cleared May 09, 1995
M. E. R. SURGICAL CO. OMIN INSTRUMENT SYSTEM
K951424 · EOX
M.E.R. Surgical Co.
Ear, Nose, Throat · 43d
Cleared May 09, 1995
NEUROSCREEN SOFTWARE FOR USE WITH THE NEUROSIGN 100 NERVE MONITOR
K951641 · ETN
The Magstim Company , Ltd.
Ear, Nose, Throat · 49d
Cleared May 03, 1995
OTOSCOPE A-34
K950788 · ERA
Neitz Instruments Company, Ltd.
Ear, Nose, Throat · 71d
Cleared May 03, 1995
THE PILOT AUDIOMETER
K951527 · EWO
American Electromedics Corp.
Ear, Nose, Throat · 30d
Cleared Apr 27, 1995
RESOUND PERSONAL HEARING SYSTEM MODELS BTP2 & BTP2/S W/REMOTE CONTROL OPTION
K951378 · ESD
Resound Corp.
Ear, Nose, Throat · 31d
Cleared Apr 27, 1995
RESOUND PERSONAL HEARING SYSTEM MODELS ED3A & ED3A/S W/REMONTE CONTROL OPTION
K951379 · ESD
Resound Corp.
Ear, Nose, Throat · 31d
Cleared Apr 17, 1995
SPECULUM, ENT (S3)
K951049 · ERA
Pedia Pals, Inc.
Ear, Nose, Throat · 42d
Cleared Apr 17, 1995
SPECULUM, ENT (S3)
K951050 · ERA
Pedia Pals, Inc.
Ear, Nose, Throat · 42d
Cleared Apr 17, 1995
INTRAARC DRIVE SYSTEM
K951263 · ERL
Linvatec Corp.
Ear, Nose, Throat · 27d
Cleared Apr 14, 1995
RESOUND PERSONAL HEARING SYSTEM BT2/S-E
K951374 · ESD
Resound Corp.
Ear, Nose, Throat · 18d
Cleared Apr 14, 1995
RESOUND PERSONAL HEARING SYSTEM ED3/S-E
K951375 · ESD
Resound Corp.
Ear, Nose, Throat · 18d