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
3625–3648 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Aug 10, 1979
MODEL SE-1 EYEGLASS HEARING AID
K791203 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 43d
Cleared Aug 03, 1979
SCREENING AUDIOMETER, HIGH FREQUENCY
K790878 · EWO
Vicon Instrument Co.
Ear, Nose, Throat · 88d
Cleared Jul 24, 1979
DUALUME LARYNGEAL EXAMINATION TELESCOPE
K790845 · ENZ
National Medical Technology
Ear, Nose, Throat · 81d
Cleared Jul 17, 1979
POPE OTO-WICK, STERILE & NON-STERILE
K791059 · KCN
Xomed, Inc.
Ear, Nose, Throat · 39d
Cleared Jul 17, 1979
MODEL CE-DM-II HEARING INSTRUMENT
K791126 · ESD
Marcon Hearing Instruments, Inc.
Ear, Nose, Throat · 29d
Cleared Jul 05, 1979
MODEL H63, BEHIND-THE-EAR
K790870 · ESD
Marcon Hearing Instruments, Inc.
Ear, Nose, Throat · 59d
Cleared Jul 03, 1979
MODEL MA3 BEHIND-THE-EAR MASKER/HEARING
K791071 · KLW
Starkey Laboratories, Inc.
Ear, Nose, Throat · 21d
Cleared Jun 27, 1979
ALLIGATOR FORECPTS, CUPPED FORCEPS
K791121 · JYR
Xomed, Inc.
Ear, Nose, Throat · 12d
Cleared Jun 27, 1979
SURGICAL SCISSORS
K791124 · KBD
Xomed, Inc.
Ear, Nose, Throat · 12d
Cleared Jun 25, 1979
MIS AURAL ACOUSTIC SCREENER
K791170 · EWO
Maico Hearing Instruments, Inc.
Ear, Nose, Throat
Cleared May 31, 1979
TRACOR MODEL RA-411 MICROPROCESSOR
K790903 · EWO
Tracor Instruments, Inc.
Ear, Nose, Throat · 20d
Cleared May 17, 1979
MIDDLE EAR ANALYZER (IMPED. AUDIOMTR)
K790846 · EWO
Grason-Stadler, Inc.
Ear, Nose, Throat · 13d
Cleared May 16, 1979
HSI MODEL C. CUSTOM IN-THE-EAR HEAR/AID
K790737 · ESD
Hearing Services, Inc.
Ear, Nose, Throat · 30d
Cleared May 01, 1979
MODEL H58-BEHIND-THE-EAR HEARING INSTR.
K790697 · ESD
Marcon Hearing Instruments, Inc.
Ear, Nose, Throat · 21d
Cleared May 01, 1979
BEHIND-THE-EAR HEARING INSTRUMENT, H56
K790700 · ESD
Marcon Hearing Instruments, Inc.
Ear, Nose, Throat · 19d
Cleared May 01, 1979
BEHIND-THE-EAR HEARING INSTRUMENT, H54
K790726 · ESD
Marcon Hearing Instruments, Inc.
Ear, Nose, Throat · 18d
Cleared May 01, 1979
BEHIND-THE-EAR, MODEL H37D
K790727 · ESD
Marcon Hearing Instruments, Inc.
Ear, Nose, Throat · 18d
Cleared May 01, 1979
_MODEL WC-1 BEHIND-THE-EAR HEARING AID
K790745 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 15d
Cleared Apr 10, 1979
HEARING AID DANAVOX 775V
K790539 · ESD
Danavox, Inc.
Ear, Nose, Throat · 21d
Cleared Apr 10, 1979
EXETER LIP SEAL
K790554 · LFA
Exeter Medical Labs, Inc.
Ear, Nose, Throat · 22d
Cleared Apr 10, 1979
AUDIOMETER
K790609 · EWO
Grason-Stadler, Inc.
Ear, Nose, Throat · 12d
Cleared Apr 10, 1979
MODEL WC-3 HEARING AID
K790651 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 7d
Cleared Apr 03, 1979
MODEL FS1
K790481 · KHL
Starkey Laboratories, Inc.
Ear, Nose, Throat · 26d
Cleared Apr 03, 1979
MODEL 4107-2S, HEARING AID
K790482 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 26d