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
2569–2592 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Jun 06, 1989
TELSTAR MODEL F ITE HEARING AID
K892458 · ESD
Telstar Electronics, Inc.
Ear, Nose, Throat · 57d
Cleared Jun 06, 1989
TELSTAR MODEL C ITE HEARING AID
K892459 · ESD
Telstar Electronics, Inc.
Ear, Nose, Throat · 57d
Cleared Jun 06, 1989
TELSTAR MODEL PP ITE HEARING AID
K892460 · ESD
Telstar Electronics, Inc.
Ear, Nose, Throat · 57d
Cleared May 31, 1989
VESTIBULAR OCULAR REFLEX TEST EQUIPMENT(VORTEQ)
K891008 · LXV
Micromedical Technologies, Inc.
Ear, Nose, Throat · 89d
Cleared May 19, 1989
INTERTON BTE HEAR AID, SUPRA, SUPREMA, MINETTA
K890525 · ESD
Magnatone Hearing Aid Corp.
Ear, Nose, Throat · 106d
Cleared May 19, 1989
REXTON RX12PP, RX20PP & RX34PP IN-THE-EAR HEAR AID
K892333 · ESD
Rexton, Inc.
Ear, Nose, Throat · 44d
Cleared May 19, 1989
BEHIND-THE-EAR HEARING AID MODEL 48 PP PC
K892336 · ESD
Qualitone
Ear, Nose, Throat · 44d
Cleared May 11, 1989
ITC & ITE HEARING AID, HEAR CLEAR MODELS 1-4
K890102 · ESD
Hear Clear, Inc.
Ear, Nose, Throat · 119d
Cleared May 10, 1989
SILICONE LARYNGEAL STENT
K884810 · FWN
Hood Laboratories
Ear, Nose, Throat · 174d
Cleared May 10, 1989
CERUMEN FILTER
K891594 · ESD
Gn Danavox, Inc.
Ear, Nose, Throat · 51d
Cleared May 10, 1989
BEHIND-THE-EAR HEARING AID MODEL 46 PP PC
K892337 · ESD
Qualitone
Ear, Nose, Throat · 35d
Cleared Apr 19, 1989
OSSICULAR PROSTHESES 4 PARTIAL, 4 TOTAL, 2 CONVERT
K885201 · ETA
Microbio-Medics, Inc.
Ear, Nose, Throat · 124d
Cleared Apr 03, 1989
VISUAL REINFORCE. AUDIO CASSETTE UNIT: BASIC & ADV
K880259 · LYN
Colorado Hearing Systems, Inc.
Ear, Nose, Throat · 437d
Cleared Mar 31, 1989
BEHIND-THE-EAR HEARING AID MODEL 408 W-H
K891251 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 23d
Cleared Mar 29, 1989
ITE HEARING AID PARKER/TECHNITONE, MODEL PA
K884997 · ESD
Hearing Enhancement Center, Inc.
Ear, Nose, Throat · 118d
Cleared Mar 29, 1989
RESOUND ITC HEARING ENHANCEMENT SYS HES2, W/REMOTE
K891011 · ESD
Resound Corp.
Ear, Nose, Throat · 29d
Cleared Mar 29, 1989
BEHIND-THE-EAR HEARING AID MODEL 304 PP-AGC-I
K891248 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 21d
Cleared Mar 29, 1989
BEHIND-THE-EAR HEARING AID MODEL 303 ASP
K891249 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 21d
Cleared Mar 29, 1989
BEHIND-THE-EAR HEARING AID MODEL 264 D-PP-PC
K891250 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 21d
Cleared Mar 24, 1989
ACCESSORY TO EYEDROP GUIDE
K884974 · JYJ
Suredrop, Inc.
Ear, Nose, Throat · 114d
Cleared Mar 22, 1989
FLEXIBLE ENDOSCOPE 91-8200(90) AND 91-82100(135)
K884631 · LRC
Xomed, Inc.
Ear, Nose, Throat · 135d
Cleared Mar 17, 1989
HOOD NASAL SPLINT
K890599 · EPP
Hood Laboratories
Ear, Nose, Throat · 39d
Cleared Mar 17, 1989
CUSTOM IN-THE-CANAL HEARING AID MODEL: I52A
K890703 · ESD
Oticon Corp.
Ear, Nose, Throat · 35d
Cleared Mar 10, 1989
AUDIOSCOPE 3 MODEL 23300 ACCESSORIES
K884218 · EWO
Welch Allyn, Inc.
Ear, Nose, Throat · 155d