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
3145–3168 of 3,805
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Nov 21, 1983
HEARING AID, UNITRON UT1
K833614 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 39d
Cleared Nov 21, 1983
HEARING AID UNITRON UI3
K833615 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 39d
Cleared Nov 14, 1983
RIONET HEARING AID HB-345
K833134 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 62d
Cleared Nov 14, 1983
BEHIND THE EAR ASP-BB
K833334 · ESD
Omni Hearing Systems
Ear, Nose, Throat · 48d
Cleared Nov 14, 1983
TEL-STAR NUWAY & GENERIC E ASP-BP
K833451 · ESD
Omni Hearing Systems
Ear, Nose, Throat · 40d
Cleared Nov 14, 1983
PANASONIC WH-50 HEARING AID
K833510 · ESD
Panasonic Co. Div. Matsu Elec. Corp....
Ear, Nose, Throat · 34d
Cleared Nov 03, 1983
SURGICAL DRILL-ELECTRIC-HANDPIECE
K831946 · ERL
Entronics
Ear, Nose, Throat · 140d
Cleared Nov 03, 1983
SILICONE SOFT-PAK EPISTAXIS CATHETER
K832476 · ENW
Axiom Medical, Inc.
Ear, Nose, Throat · 100d
Cleared Oct 28, 1983
DAHLBERG #USS IN THE EAR HEARING AID
K833073 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 49d
Cleared Oct 19, 1983
CODY SACCULOTOMY TACK
K832068 · ESX
Micromedics, Inc.
Ear, Nose, Throat · 114d
Cleared Oct 14, 1983
CONCEPT T-TUBE
K832361 · ETD
Concept, Inc.
Ear, Nose, Throat · 88d
Cleared Oct 14, 1983
DONALDSON-TYPE VENT TUBE
K832362 · ETD
Concept, Inc.
Ear, Nose, Throat · 88d
Cleared Sep 29, 1983
REXTON RX10, RX20-30 & 40
K832180 · ESD
Rexton, Inc.
Ear, Nose, Throat · 85d
Cleared Sep 29, 1983
BEHIND-THE-EAR #123 AGCI
K832326 · ESD
Danavox, Inc.
Ear, Nose, Throat · 76d
Cleared Sep 29, 1983
WIDEX HEARING AID MODEL L1
K832376 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 73d
Cleared Sep 29, 1983
LUCAE'S EAR & NASAL APPLICATORS
K832667 · KCJ
Kells Medical, Inc.
Ear, Nose, Throat · 51d
Cleared Sep 29, 1983
HSI ELITE #EC CUSTOM CANAL HEAR-AID
K832701 · ESD
Hearing Services, Inc.
Ear, Nose, Throat · 49d
Cleared Sep 29, 1983
BEHIND-THE-EAR SERIES 125
K832751 · ESD
Danavox, Inc.
Ear, Nose, Throat · 45d
Cleared Sep 29, 1983
BLAISE-RATHAEL VOICE PROSTHESIS
K832852 · EWL
Richards Medical Co., Inc.
Ear, Nose, Throat · 44d
Cleared Sep 20, 1983
LARYNGOTELESCOPE CURVED MLC-1
K832449 · EOQ
Pentax Precision Instrument Corp.
Ear, Nose, Throat · 57d
Cleared Sep 20, 1983
BRONCHO FIBERSCOPE FB-19C
K832492 · EOQ
Pentax Precision Instrument Corp.
Ear, Nose, Throat · 55d
Cleared Sep 12, 1983
LARYNGOSCOPE ATTACHMENT PH2000
K831255 · EQN
Eder Instrument Co, Inc.
Ear, Nose, Throat · 147d
Cleared Sep 12, 1983
METAVOX MV-1000 AUDITORY TRAINER
K832190 · EPF
Metavox, Inc.
Ear, Nose, Throat · 66d
Cleared Aug 26, 1983
TACTIL EAR
K831501 · LRA
Ear Three Systems
Ear, Nose, Throat · 107d