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
1201–1224 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Jul 03, 1997
CUSTOM NASAL SPLINT
K972082 · LYA
Boston Medical Products, Inc.
Ear, Nose, Throat · 29d
Cleared Jun 26, 1997
MEDIVISION SINOSCOPE
K971995 · EOB
Medivision Scope Service Center, Inc.
Ear, Nose, Throat · 27d
Cleared Jun 26, 1997
EPI-MAX EPISTAXIS CATHETER
K972076 · EMX
Boston Medical Products, Inc.
Ear, Nose, Throat · 23d
Cleared Jun 26, 1997
EPI-STOP EPISTAXIS CATHETER
K972077 · EMX
Boston Medical Products, Inc.
Ear, Nose, Throat · 23d
Cleared Jun 20, 1997
TONDI, MODELS U-03, U-2M1, U-2M4, KA-01, KA-02, KA-03, KA-03A, KA-04, KA-04A,...
K971296 · ESD
National Hearing Aid Dist., Inc.
Ear, Nose, Throat · 74d
Cleared Jun 17, 1997
AUDALLION III HEARING SYSTEM
K971031 · ESD
Gn Danavox, Inc.
Ear, Nose, Throat · 88d
Cleared Jun 17, 1997
DANAVOX MODELS 163/162 BTE
K971032 · ESD
Gn Danavox, Inc.
Ear, Nose, Throat · 88d
Cleared Jun 13, 1997
DUALINE 400 CIC
K971158 · ESD
Bernafon-Maico, Inc.
Ear, Nose, Throat · 77d
Cleared Jun 13, 1997
AURIS AE, AURIS TL, AURIS HS, AURIS AC, AURIS MM, AURIS COE, AURIS CIC
K971399 · ESD
General Hearing Instruments, Inc.
Ear, Nose, Throat · 59d
Cleared Jun 06, 1997
GSI SA60 DPOAE SYSTEM
K970324 · ETW
Grason-Stadler, Inc.
Ear, Nose, Throat · 130d
Cleared Jun 06, 1997
POWER D, TRU 5, PERSONA, PERSONA CHOICE, MERIDIAN
K970880 · ESD
Micro-Ear Technology, Inc.
Ear, Nose, Throat · 88d
Cleared Jun 06, 1997
VISTA V-38 CIC
K970939 · ESD
Vista Labs
Ear, Nose, Throat · 85d
Cleared Jun 06, 1997
MAICO MA52
K971080 · EWO
Bernafon-Maico, Inc.
Ear, Nose, Throat · 73d
Cleared Jun 06, 1997
NEURO PULSE II,III
K971143 · ETN
Aaron Medical Industries
Ear, Nose, Throat · 70d
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