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
1201–1224 of 3,798
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Jun 06, 1997
PROVOX 2 VOICE PROSTHESIS SYSTEM
K971244 · EWL
Atos Medical AB
Ear, Nose, Throat · 64d
Cleared Jun 06, 1997
SCIENTIFIC PLASTICS MODEL SP
K971299 · ESD
Scientific Plastics, Inc.
Ear, Nose, Throat · 60d
Cleared Jun 06, 1997
WIDEX SENSO DIGITAL (MINI CANAL)
K971535 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 39d
Cleared Jun 06, 1997
RIONET HB-79P
K971693 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 30d
Cleared Jun 06, 1997
PHILIPS S1694, S1695
K971804 · ESD
Philips Hearing Instruments Co.
Ear, Nose, Throat · 23d
Cleared Jun 03, 1997
DISPOSABLE SILICONE EPISTAXIS CATHETER V-27030/DISPOSABLE SILICONE EPISTAXIS...
K971411 · EMX
Bentec Medical, Inc.
Ear, Nose, Throat · 48d
Cleared Jun 02, 1997
SILICONE PUTTY EAR PLUGS
K971517 · EWD
Bentec Medical, Inc.
Ear, Nose, Throat · 38d
Cleared May 29, 1997
TYMPANOSTOMY VENTILATION TUBE
K971454 · ETD
Ikonos Corp.
Ear, Nose, Throat · 38d
Cleared May 28, 1997
EARCHECK PRO
K970685 · ETY
Mdi Instruments, Inc.
Ear, Nose, Throat · 93d
Cleared May 28, 1997
UHS MICRONET PROGRAMMABLE HEARING AIDS MODELS 901,902,903,906,909/PROGRAMMER
K970828 · ESD
United Hearing Systems, Inc.
Ear, Nose, Throat · 83d
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