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
1777–1800 of 3,798
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Jun 24, 1994
FLUOROFILM(R)
K933800 · EMX
American Custom Medical, Inc.
Ear, Nose, Throat · 324d
Cleared Jun 24, 1994
HEARING TECH
K941587 · ESD
Hearing Tech, Inc.
Ear, Nose, Throat · 85d
Cleared Jun 24, 1994
PHONAK MICROVOX RESONAL FM SYSTEM
K941768 · EPF
Phonak, Inc.
Ear, Nose, Throat · 74d
Cleared Jun 24, 1994
EUROSTAR SUPER, EUROSTAR VFC
K942036 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 57d
Cleared Jun 24, 1994
REPLACEMENT BATTERIES/WELCH ALLYN #72200 POWER HANDLE
K942244 · ERA
National Custom Ent., Inc.
Ear, Nose, Throat · 87d
Cleared Jun 22, 1994
PROVOX(TM) VOICE PROSTHESIS
K940638 · EWL
Atos Medical AB
Ear, Nose, Throat · 128d
Cleared Jun 21, 1994
SAPHIRE PLUS SURGICAL MIRROR
K934911 · EQH
San Diego Swiss Machining, Inc.
Ear, Nose, Throat · 250d
Cleared Jun 20, 1994
INTERACOUSTICS DIAGNOSTIC AUDIOMETER
K942006 · EWO
Precision Acoustics Ind., Inc.
Ear, Nose, Throat · 56d
Cleared Jun 17, 1994
SHARP II HELIX HEARING AID
K941295 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 92d
Cleared Jun 17, 1994
PHILIPS 61 SERIES
K942164 · ESD
Philips Hearing Instruments Co.
Ear, Nose, Throat · 44d
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