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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Ear, Nose, Throat ×
3,805 results
3601–3624 of 3,805
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Oct 26, 1979
MODEL TM5 BEHIND EAR TINNITUS MASKER
K791790 · KLW
Starkey Laboratories, Inc.
Ear, Nose, Throat · 45d
Cleared Oct 26, 1979
RIONET HEARING AID HB-64S
K791879 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 56d
Cleared Oct 26, 1979
OTOTOME BUR
K792028 · EQJ
American Sterilizer Co.
Ear, Nose, Throat · 17d
Cleared Oct 22, 1979
THE DENVER SPLINT
K791681 · EPP
Xomed, Inc.
Ear, Nose, Throat · 55d
Cleared Oct 10, 1979
BILSOM PROPP
K791608 · EWD
Bilson International, Inc.
Ear, Nose, Throat · 58d
Cleared Sep 28, 1979
HEARING AID, MODEL MA-1
K791142 · KLW
Starkey Laboratories, Inc.
Ear, Nose, Throat · 102d
Cleared Sep 28, 1979
DAHLBERG HEARING AID MODEL GC
K791310 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 74d
Cleared Sep 28, 1979
TA-10 PORTABLE SCREENING AUDIOMETER
K791467 · EWO
Teledyne Avionics Div. of Teledyne
Ear, Nose, Throat · 53d
Cleared Sep 28, 1979
MODEL 33DA HEARING AIDS
K791599 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 45d
Cleared Sep 28, 1979
MODEL 33A HEARING AIDS
K791600 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 45d
Cleared Sep 28, 1979
MODEL 336A HEARING AIDS
K791601 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 45d
Cleared Sep 19, 1979
DAHLBERG HEARING AID MODEL UN
K791311 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 65d
Cleared Sep 19, 1979
MODEL 344
K791506 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 47d
Cleared Sep 17, 1979
EARETTE HEARING AID
K791356 · ESD
Oticon Corp.
Ear, Nose, Throat · 59d
Cleared Aug 22, 1979
ARGYLE TAUSSIG CULTURE CATHETER
K791327 · KTR
Sherwood Medical Co.
Ear, Nose, Throat · 37d
Cleared Aug 22, 1979
WOMED NICRO-CRAFT POWER SYSTEM
K791407 · ERL
Xomed, Inc.
Ear, Nose, Throat · 22d
Cleared Aug 16, 1979
THE DENVER SPLINT
K791053 · EPP
Ronald D. Shippert, M.D.
Ear, Nose, Throat · 71d
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