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
1345–1368 of 3,798
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Jul 30, 1996
OLYMPUS FB SERIES BIOPSY FORCEPS
K962555 · EOQ
Olympus America, Inc.
Ear, Nose, Throat · 29d
Cleared Jul 29, 1996
MILL-ROSE LARYNGOSCOPIC INJECTION NEEDLE
K962736 · EOQ
Mill-Rose Laboratory
Ear, Nose, Throat · 14d
Cleared Jul 25, 1996
MISTEN MEDICAL MISTEN MEDICAL SURGICAL DRILL
K962163 · ERL
Misten Medical Corp.
Ear, Nose, Throat · 51d
Cleared Jul 25, 1996
SIEMENS VITA 160 SERIES POCKET HEARING INSTRUMENT: VITA 162E,166M,168PP
K962170 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 50d
Cleared Jul 25, 1996
MONTGOMERY RADIOPAQUE SALIVARY BYPASS TUBE
K962688 · KCF
Boston Medical Products, Inc.
Ear, Nose, Throat · 14d
Cleared Jul 05, 1996
KARL STORZ TWIN TRANSILLUMINATOR
K962032 · MQW
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 42d
Cleared Jul 03, 1996
IN-THE-EAR
K961827 · ESD
Qualitone
Ear, Nose, Throat · 51d
Cleared Jul 03, 1996
RIONET HEARING AID HB53-K
K961907 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 48d
Cleared Jul 02, 1996
DISPOSABLE ENDOSHEATH FOR E-F100 FLEXIBLE NASOPHARYNGOSCOPE
K961591 · EOB
Vision-Sciences, Inc.
Ear, Nose, Throat · 69d
Cleared Jul 01, 1996
ACTIVENT ANTIMICROBIAL VENTILATION TUBES
K961873 · ETD
Xomed, Inc.
Ear, Nose, Throat · 47d
Cleared Jun 11, 1996
TYMPANOSTOMY VENTILATION TUBE
K961945 · ETD
Advanced Microbotics Corp.
Ear, Nose, Throat · 22d
Cleared May 30, 1996
BREATHE RIGHT NASAL STRIP
K955711 · LWF
Cns, Inc.
Ear, Nose, Throat · 164d
Cleared May 29, 1996
SCOUT SPORT - A MODIFICATION TO (FORMERLY EMAV) OTOACOUSTIC EMISSIONS (OAE)...
K961447 · EWO
Bio-Logic Systems Corp.
Ear, Nose, Throat · 43d
Cleared May 29, 1996
PHONAK SONA P2
K961653 · ESD
Phonak, Inc.
Ear, Nose, Throat · 29d
Cleared May 29, 1996
ARGOSY PROGRAMMABLE
K961729 · ESD
Argosy Electronics
Ear, Nose, Throat · 26d
Cleared May 17, 1996
PHONAK PICONET2 P2 AZ
K961622 · ESD
Phonak, Inc.
Ear, Nose, Throat · 21d
Cleared May 14, 1996
POLY/PLATINUM WIRE PISTON
K945105 · ETB
Micromed Development Corp.
Ear, Nose, Throat · 574d
Cleared May 14, 1996
KARL STORZ INTUBATION FIBERSCOPE
K961178 · EOQ
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 49d
Cleared May 14, 1996
CLARITY
K961670 · ESD
Seig Technologies, Inc.
Ear, Nose, Throat · 14d
Cleared May 08, 1996
FIVE STAR BRONCHOSCOPE
K960876 · EOB
Five Star Medical, Inc.
Ear, Nose, Throat · 65d
Cleared May 07, 1996
COMFORTONE PHS
K960741 · ESD
Comfortone America'S Value Hearing...
Ear, Nose, Throat · 74d
Cleared May 07, 1996
DIGIFOCUS COMPACT
K961059 · ESD
Oticon, Inc.
Ear, Nose, Throat · 50d
Cleared May 07, 1996
TECHNA TONE
K961082 · ESD
Techna Tone
Ear, Nose, Throat · 50d
Cleared May 07, 1996
TELEX SELECT 2-40 WITH ADAPTIVE COMPRESSION S2-40
K961143 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 47d