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
1945–1968 of 3,798
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Aug 17, 1993
XOMED-TREACE EMG ENDOTRACHEAL TUBEEN
K925640 · ETN
Xomed-Treace, Inc.
Ear, Nose, Throat · 281d
Cleared Aug 17, 1993
MEROCEL MEROSPLINT
K933152 · LYA
Merocel Corp.
Ear, Nose, Throat · 49d
Cleared Aug 09, 1993
PRIZM HEARING SYSTEM
K930909 · ESD
Audioscience, Inc.
Ear, Nose, Throat · 180d
Cleared Aug 05, 1993
MA25 - PORTABLE AUDIOMETER, MODIFICATION
K926439 · EWO
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 225d
Cleared Aug 05, 1993
MAICO MA790 AUDIOMETER
K930112 · EWO
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 206d
Cleared Aug 05, 1993
OTICON MF
K932670 · ESD
Oticon Corp.
Ear, Nose, Throat · 64d
Cleared Aug 03, 1993
OTOSCOPE
K925758 · ERA
Rudolf Riester GmbH & Co. KG
Ear, Nose, Throat · 263d
Cleared Aug 02, 1993
GOLD ASP MODULE, ITE
K933036 · ESD
Electone, Inc.
Ear, Nose, Throat · 96d
Cleared Aug 02, 1993
GOLD K AMP, ITE
K933037 · LRB
Electone, Inc.
Ear, Nose, Throat · 96d
Cleared Aug 02, 1993
GOLD AF MODULE, ITE
K933038 · LRB
Electone, Inc.
Ear, Nose, Throat · 96d
Cleared Aug 02, 1993
GOLD L MODULE, ITE
K933039 · LRB
Electone, Inc.
Ear, Nose, Throat · 96d
Cleared Aug 02, 1993
GOLD CD MODULE, ITE
K933040 · LRB
Electone, Inc.
Ear, Nose, Throat · 96d
Cleared Aug 02, 1993
SILVER COMPRESSION MODULE, ITE
K933042 · ESD
Electone, Inc.
Ear, Nose, Throat · 96d
Cleared Aug 02, 1993
SILVER PPP MODULE, ITE
K933043 · LRB
Electone, Inc.
Ear, Nose, Throat · 96d
Cleared Aug 02, 1993
SILVER LD MODULE, ITE
K933044 · LRB
Electone, Inc.
Ear, Nose, Throat · 96d
Cleared Aug 02, 1993
SILVER RECHARGEABLE MODULE, ITE
K933045 · LRB
Electone, Inc.
Ear, Nose, Throat · 96d
Cleared Aug 02, 1993
SILVER L MODULE, ITE
K933046 · LRB
Electone, Inc.
Ear, Nose, Throat · 96d
Cleared Jul 30, 1993
BAL CATH
K923487 · KTR
Ballard Medical Products
Ear, Nose, Throat · 380d
Cleared Jul 27, 1993
PHONAK PICO-FORTE SC-2
K932734 · ESD
Phonak, Inc.
Ear, Nose, Throat · 50d
Cleared Jul 27, 1993
PHONAK PICO-FORTE SC-D-2
K932735 · ESD
Phonak, Inc.
Ear, Nose, Throat · 50d
Cleared Jul 27, 1993
STARKEY TRILOGY II PROGRAMMABLE HEARING AID
K933113 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 32d
Cleared Jul 26, 1993
UNI I
K925759 · ERA
Rudolf Riester GmbH & Co. KG
Ear, Nose, Throat · 255d
Cleared Jul 26, 1993
SILICONE TYMPANOSTOMY TUBES
K932166 · ETD
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 83d
Cleared Jul 26, 1993
ACCESSORIES FOR ENDOSCOPES FOR SINUS SURGERY
K932988 · EOB
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 38d