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
1801–1824 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Jun 17, 1994
OPTIMA WITH DELTA AMP
K942213 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 42d
Cleared Jun 17, 1994
AUDINA PREWIRES (FACEPLATE HEARING AID SERIES)
K942236 · LRB
Audina Hearing Instrument
Ear, Nose, Throat · 39d
Cleared Jun 15, 1994
BELTONE INVISA
K940098 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 156d
Cleared Jun 08, 1994
BLACK OVAL-TOP TORP/PORP
K934107 · ETA
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 289d
Cleared Jun 08, 1994
DISPOSABLE NASAL SCISSOR
K942063 · LRC
United States Surgical, A Division of...
Ear, Nose, Throat · 40d
Cleared Jun 08, 1994
DISPOSABLE NASAL RONGEUR
K942064 · LRC
United States Surgical, A Division of...
Ear, Nose, Throat · 40d
Cleared Jun 06, 1994
DISPOSABLE ENT PUNCH
K942065 · LRC
United States Surgical, A Division of...
Ear, Nose, Throat · 38d
Cleared May 23, 1994
THE EXPANDACELL EAR PACK
K940133 · LRD
Denver Splint Co.
Ear, Nose, Throat · 140d
Cleared May 23, 1994
INTERACOUSTICS. HEARING AID ANALYZER
K941848 · ETW
Precision Acoustics Ind., Inc.
Ear, Nose, Throat · 39d
Cleared May 16, 1994
STRYKER MICRODEBRIDER SYSTEM
K940710 · ERL
Stryker Corp.
Ear, Nose, Throat · 88d
Cleared May 16, 1994
JARIT RECOMMENDED SINUS INSTRUMENTS
K941565 · EOB
J. Jamner Surgical Instruments, Inc.
Ear, Nose, Throat · 45d
Cleared May 13, 1994
PRO-CONNECT
K932269 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 367d
Cleared May 13, 1994
NERVE INTEGRITY MONITOR-2 (NIM-2 XL)
K934426 · ETN
Xomed-Treace, Inc.
Ear, Nose, Throat · 245d
Cleared May 13, 1994
PHONAK SONO-FORTE 331X BTE HEARING INSTRUMENTS
K941734 · ESD
Phonak, Inc.
Ear, Nose, Throat · 36d
Cleared May 12, 1994
THE EXPANDACELL SINUS PACK
K935724 · EMX
Denver Splint Co.
Ear, Nose, Throat · 162d
Cleared May 12, 1994
WAX GUARD OPTION
K941039 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 70d
Cleared May 12, 1994
AUDIOTONE MODEL A-54
K941121 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 64d
Cleared May 12, 1994
AUDIOTONE MODEL A-54SR
K941122 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 64d
Cleared May 12, 1994
770-ATC
K941133 · ESD
Electone, Inc.
Ear, Nose, Throat · 64d
Cleared May 12, 1994
SHARP II FULL CONTOUR
K941292 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 56d
Cleared May 12, 1994
SHARP II SEMI CONTOUR HEARING AID
K941293 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 56d
Cleared May 12, 1994
SHARP II LOW PROFILE HEARING AID
K941294 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 56d
Cleared May 10, 1994
MODEL 222 CLINICAL AUDIOMETER
K934715 · EWO
Virtual Corp.
Ear, Nose, Throat · 221d
Cleared May 10, 1994
VIENNATONE AN, VIENNATONE AS FIDELITY F228, FIDELITY F229
K935701 · LXB
Starkey Laboratories, Inc.
Ear, Nose, Throat · 161d