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
2089–2112 of 3,798
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Sep 28, 1992
RIONET HB75-AL BTE AID
K923801 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 61d
Cleared Sep 23, 1992
DANPLEX SCREENING AUDIOMETER
K923074 · EWO
Life-Tech Intl., Inc.
Ear, Nose, Throat · 90d
Cleared Sep 23, 1992
ITC HEARING AID CLUB MODEL LM50H
K923293 · ESD
Club Hearing Instruments A/S
Ear, Nose, Throat · 83d
Cleared Sep 23, 1992
BTE HEARING AID CLUB MODEL: ST60
K923294 · ESD
Club Hearing Instruments A/S
Ear, Nose, Throat · 83d
Cleared Sep 23, 1992
ITC HEARING AID CLUB MODEL LM40
K923295 · ESD
Club Hearing Instruments A/S
Ear, Nose, Throat · 83d
Cleared Sep 23, 1992
BTE HEARING AID CLUB MODEL ST70
K923296 · ESD
Club Hearing Instruments A/S
Ear, Nose, Throat · 83d
Cleared Sep 14, 1992
FLEXIBLE FIBER OPTIC ENDOSCOPE
K922937 · EOQ
Optimed Technologies, Inc.
Ear, Nose, Throat · 88d
Cleared Sep 10, 1992
BLOM-SINGER TRACHEOESOPHAGEAL PUNCTURE SET
K920090 · EWL
Helix Medical, Inc.
Ear, Nose, Throat · 246d
Cleared Sep 10, 1992
IN-THE-EAR HEARING AID
K923918 · ESD
Benway-Haworth-Lawlor Hearing Aids, Inc.
Ear, Nose, Throat · 36d
Cleared Sep 10, 1992
CYBERNETIC OPTION (CYBER I)
K923986 · ESD
Qualitone
Ear, Nose, Throat · 34d
Cleared Sep 09, 1992
ENDOPATH TISSUE RETAINING COMPONENT
K923679 · KCJ
Ethicon Endo-Surgery, Inc.
Ear, Nose, Throat · 49d
Cleared Sep 04, 1992
SINGH SPEECH SYSTEM (SERIES 'SSS')
K912486 · EWL
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 458d
Cleared Sep 04, 1992
OMEGA OTO NASOPHARYNGO-LARYNGOSCOPE
K920439 · EOB
Omega Universal Technologies, Ltd.
Ear, Nose, Throat · 214d
Cleared Sep 04, 1992
STARKEY LABORATORIES OTOSCOPE
K922752 · ERA
Starkey Laboratories, Inc.
Ear, Nose, Throat · 88d
Cleared Aug 26, 1992
STARKEY SM SERIES BTE HEARING AIDS
K923784 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 29d
Cleared Aug 24, 1992
GROUP AUDITORY TRAINING SYSTEM
K922720 · EPF
Phonic Ear, Inc.
Ear, Nose, Throat · 80d
Cleared Aug 24, 1992
VOICEWAVE
K923924 · ESD
Personal Sound Technologies, Inc.
Ear, Nose, Throat · 19d
Cleared Aug 20, 1992
IMAGICA MICRO-ENDOSCOPE
K921393 · EOQ
Fiberoptic Medical Products, Inc.
Ear, Nose, Throat · 150d
Cleared Aug 18, 1992
SIEMENS MODEL INFINITI 1001 B
K923379 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 40d
Cleared Aug 18, 1992
SIEMENS MODEL TRITON 3004 B
K923380 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 40d
Cleared Aug 14, 1992
ACOUSTIC APPRAISE CD-3
K923013 · EWO
Qualitone
Ear, Nose, Throat · 53d
Cleared Aug 11, 1992
PHILIP XP SERIES, IN-THE CANAL HEARING AID
K921725 · ESD
Philips Hearing Instruments Co.
Ear, Nose, Throat · 124d
Cleared Aug 06, 1992
LAPAROMED LIGATING LOOP
K921053 · KCJ
Laparomed Corp.
Ear, Nose, Throat · 154d
Cleared Aug 06, 1992
RESOUND PERSONAL HEARING SYSTEM SOUNDLINK-1
K922570 · EPF
Resound Corp.
Ear, Nose, Throat · 66d