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
1177–1200 of 3,798
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Jul 23, 1997
MERIDIAN DSP
K972431 · ESD
Micro-Ear Technology, Inc.
Ear, Nose, Throat · 29d
Cleared Jul 23, 1997
JAZZ PP AGC-O, JAZZ PP
K972542 · ESD
Trutone
Ear, Nose, Throat · 14d
Cleared Jul 23, 1997
TWIST PPAGC-1, TWIST PP
K972543 · ESD
Trutone
Ear, Nose, Throat · 14d
Cleared Jul 15, 1997
BIVALVE NASAL SPLINT
K972096 · LYA
Boston Medical Products, Inc.
Ear, Nose, Throat · 41d
Cleared Jul 10, 1997
POST-STOP EPISTAXIS CATHETER
K972078 · EMX
Boston Medical Products, Inc.
Ear, Nose, Throat · 37d
Cleared Jul 08, 1997
NASAL AIRWAY SPLINT
K972092 · LYA
Boston Medical Products, Inc.
Ear, Nose, Throat · 34d
Cleared Jul 07, 1997
DOYLE COMBO NASAL AIRWAY SPLINT
K972151 · LYA
Boston Medical Products, Inc.
Ear, Nose, Throat · 28d
Cleared Jul 03, 1997
RESOUND ED4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION
K971605 · ESD
Resound Corp.
Ear, Nose, Throat · 63d
Cleared Jul 03, 1997
ARGOSY DYNAMEQ
K971699 · ESD
Argosy Electronics
Ear, Nose, Throat · 56d
Cleared Jul 03, 1997
NASAL SEPTAL BUTTON
K972060 · LFB
Boston Medical Products, Inc.
Ear, Nose, Throat · 31d
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