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
1969–1992 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
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
Cleared Jul 26, 1993
351-AGCO BEHIND-THE-EAR HEARING AID
K933095 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 32d
Cleared Jul 22, 1993
SYMBIOSIS ENT SURGICAL INSTRUMENTS
K931793 · LRC
Symbiosis Corp.
Ear, Nose, Throat · 101d
Cleared Jul 21, 1993
EAR CURETTE
K932609 · JYG
Ear Tech, Inc.
Ear, Nose, Throat · 54d
Cleared Jul 20, 1993
RESOUND PERSONAL HEARING SYSTEM BT-P W/PHS BT-P
K931942 · ESD
Resound Corp.
Ear, Nose, Throat · 92d
Cleared Jul 14, 1993
VINYL ADDITION SILICONE SYSTEM
K926150 · ESD
Crown Delta Corp.
Ear, Nose, Throat · 219d
Cleared Jul 14, 1993
BELTONE OPERA/OPERA MHP/OPERA MAX
K932426 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 56d
Cleared Jul 13, 1993
MILL-ROSE PULMONARY FORCEPS
K922204 · EOQ
Mill-Rose Laboratory
Ear, Nose, Throat · 428d
Cleared Jul 13, 1993
ACOUSTIC ANALYZER AA30
K930260 · EWO
Precision Acoustics Ind., Inc.
Ear, Nose, Throat · 175d
Cleared Jul 08, 1993
MODEL 322 CLINICAL AUDIOMETER
K930203 · EWD
Virtual Corp.
Ear, Nose, Throat · 175d
Cleared Jul 08, 1993
PHONAK LEXA 231X ITE SERIES HEARING SINSTRUMENT
K932175 · ESD
Phonak, Inc.
Ear, Nose, Throat · 64d