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
2545–2568 of 3,798
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Jun 21, 1989
HANDTYMP SCREENER MODEL 2000 + 2002 REMOTE TRANS.
K890864 · ETY
Rastronics USA, Inc.
Ear, Nose, Throat · 120d
Cleared Jun 21, 1989
CANNULATED BIOPSY FORCEPS
K892687 · EOQ
Zinnanti Surgical Instruments, Inc.
Ear, Nose, Throat · 69d
Cleared Jun 16, 1989
OSSICULAR PROSTHESIS: 8 PARTIAL, 3 TOTAL
K884884 · ETA
Porex Technologies Corp. of Georgia
Ear, Nose, Throat · 206d
Cleared Jun 16, 1989
ALPHA MODEL I ITE HEARING AID
K890271 · ESD
Alpha Instruments, Inc.
Ear, Nose, Throat · 149d
Cleared Jun 16, 1989
JESBERG ESOPHAGOSCOPE
K892259 · EOX
Zinnanti Surgical Instruments, Inc.
Ear, Nose, Throat · 73d
Cleared Jun 14, 1989
PERSONAL AMPLIFIER MODEL ULTRA HELIX
K893433 · ESD
Electone, Inc.
Ear, Nose, Throat · 43d
Cleared Jun 09, 1989
STORZ DX CENTER:IMPEDANCE TEST W/RHINO & AUDIO OPT
K883293 · ETY
Storz Instrument Co.
Ear, Nose, Throat · 309d
Cleared Jun 07, 1989
2400 AUDIOMETER, IMPEDANCE METER & HRNG. AID ANALY
K890842 · EWO
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 106d
Cleared Jun 06, 1989
MODEL 20-P EXTENDED HIGH FREQUENCY AUDIOMETER
K890497 · EWO
Monitor/Demlar
Ear, Nose, Throat · 125d
Cleared Jun 06, 1989
TELSTAR MODEL 1/3 ITE HEARING AID
K892457 · ESD
Telstar Electronics, Inc.
Ear, Nose, Throat · 57d
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