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
1225–1248 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared May 16, 1997
TM MICRO-CATHETERS
K971124 · ETD
Xomed, Inc.
Ear, Nose, Throat · 50d
Cleared May 14, 1997
NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR
K964869 · ETN
The Magstim Company , Ltd.
Ear, Nose, Throat · 161d
Cleared May 14, 1997
EPISTAXIS NASAL PACK
K971000 · EMX
Invotec International, Inc.
Ear, Nose, Throat · 56d
Cleared May 13, 1997
MODIFICATION TO OTOACOUSTIC EMISSIONS (OAE0 TEST INSTRUMENT
K964132 · EWO
Bio-Logic Systems Corp.
Ear, Nose, Throat · 210d
Cleared May 08, 1997
UNITRON MODEL SOUND F/X CIC
K970692 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 72d
Cleared May 02, 1997
WILLIAMS SOUND, PERSONAL FM, HEARING HELPER
K970665 · EPF
Williams Sound, LLC
Ear, Nose, Throat · 70d
Cleared May 02, 1997
WILLIAMS SOUND, PERSONAL FM, HEARING HELPER
K970687 · EPF
Williams Sound, LLC
Ear, Nose, Throat · 67d
Cleared May 02, 1997
XOMED SILICONE BLOCK/STRIP
K970910 · KHJ
Xomed, Inc.
Ear, Nose, Throat · 51d
Cleared May 02, 1997
PRECISE IMPRESSION KIT
K970952 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 49d
Cleared May 02, 1997
WILLIAMS SOUND, PERSONAL FM SYSTEM, HEARING HELPER
K970974 · LZI
Williams Sound, LLC
Ear, Nose, Throat · 46d
Cleared Apr 24, 1997
UNITRON MODEL SOUND F/X PROGRAMMABLE ITE (SF/X PROGRAMMABLE)
K970519 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 72d
Cleared Apr 21, 1997
IN THE EAR HEARING AID
K964898 · ESD
Keytone Hearing Laboratory
Ear, Nose, Throat · 136d
Cleared Apr 09, 1997
MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III)
K970965 · ERL
Midas Rex Pneumatic Tools, Inc.
Ear, Nose, Throat · 23d
Cleared Apr 04, 1997
SHARPSITE AC
K965233 · EOB
Xomed, Inc.
Ear, Nose, Throat · 94d
Cleared Mar 31, 1997
AUDALLION II HEARING SYSTEM
K970215 · ESD
Resound Corp.
Ear, Nose, Throat · 69d
Cleared Mar 31, 1997
MULTI-CHANNEL COMPRESSION BTE (SD)
K970262 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 67d
Cleared Mar 28, 1997
FAST TRACT TRANSTRACHEAL PROCEDURE KIT
K970018 · LRC
L.W. Ward and Assoc., Inc.
Ear, Nose, Throat · 85d
Cleared Mar 28, 1997
REXTON MODEL 48 AND 49PP
K970537 · ESD
Rexton, Inc.
Ear, Nose, Throat · 44d
Cleared Mar 26, 1997
AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIER
K970340 · LZI
Bellab
Ear, Nose, Throat · 56d
Cleared Mar 26, 1997
WIDEX SENSO DIGITAL (CIC)
K970904 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 14d
Cleared Mar 21, 1997
SMITH & NEPHEW IMAGES ARTHROSCOPE/ENT ENDOSCOPE
K970247 · EOB
Smith & Nephew, Inc.
Ear, Nose, Throat · 58d
Cleared Mar 18, 1997
RACE CAR TYMPANOMETER WITH AUDIOMETER(AE-RCAUD I/QUIK TYMP 1(AE-QUIK 1)/QUICK...
K970279 · EWO
American Electromedics Corp.
Ear, Nose, Throat · 54d
Cleared Mar 17, 1997
IL0292 DP ECHOPORT
K970555 · EWO
Smith
Ear, Nose, Throat · 32d
Cleared Mar 12, 1997
WIDEX MODEL SENSO DIGITAL (C9)
K965254 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 72d