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
1873–1896 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Feb 09, 1994
ODYSSEY CLINICAL AUDIOMETER
K935348 · EWO
Qualitone
Ear, Nose, Throat · 96d
Cleared Feb 07, 1994
HEARIT
K934805 · LZI
Je Liss & Co., Inc.
Ear, Nose, Throat · 123d
Cleared Feb 01, 1994
GSI 60 DPOAE SYSTEM
K934658 · EWO
Lucas Grason-Stadler, Inc.
Ear, Nose, Throat · 126d
Cleared Jan 27, 1994
NASOPHARYNGOSCOPE
K934422 · EOB
Marks & Murase
Ear, Nose, Throat · 136d
Cleared Jan 27, 1994
HEARING AIDS HB-36M, HB-36MS, HB-36MT, HI-67P, EXCEL-1000
K935559 · ESD
Rockwin Corp.
Ear, Nose, Throat · 71d
Cleared Jan 26, 1994
VB-1830/VB-1530, VIDEO BRONCHOSCOPE
K934920 · EOQ
Pentax Precision Instrument Corp.
Ear, Nose, Throat · 103d
Cleared Jan 26, 1994
PHONAK PICONET 232X-AZ BTE HEARING INSTRUMENT
K935791 · ESD
Phonak, Inc.
Ear, Nose, Throat · 50d
Cleared Jan 24, 1994
SOUND SELECTOR FULL-SERVICE AUDIOMETER
K933097 · EWO
Ensoniq Corp.
Ear, Nose, Throat · 214d
Cleared Jan 21, 1994
GLASER RT450 HEARING AID TEST AND ANALYSIS SYSTEM
K934342 · ETW
Glaser Instruments AG
Ear, Nose, Throat · 136d
Cleared Jan 21, 1994
GLASER RT60, RT80, RT150 AUDIOMETER
K934343 · EWO
Glaser Instruments AG
Ear, Nose, Throat · 136d
Cleared Jan 21, 1994
NU-EAR SD-10 IN THE CANAL HEARING AID
K935326 · ESD
Nu-Ear Electronics
Ear, Nose, Throat · 77d
Cleared Jan 21, 1994
NU.EAR SD-2 IN-THE-CANAL (ITC) HEARING AID
K935327 · ESD
Nu-Ear Electronics
Ear, Nose, Throat · 77d
Cleared Jan 21, 1994
NU.EAR SS-2 IN THE CANAL (ITC) HEARING AID
K935328 · ESD
Nu-Ear Electronics
Ear, Nose, Throat · 77d
Cleared Jan 21, 1994
NU.EAR AE-2 IN THE CANAL (ITC) HEARING AID
K935329 · ESD
Nu-Ear Electronics
Ear, Nose, Throat · 77d
Cleared Jan 21, 1994
NU.EAR SS-3 IN THE CANAL (ITC) HEARING AID
K935330 · ESD
Nu-Ear Electronics
Ear, Nose, Throat · 77d
Cleared Jan 21, 1994
NU.EAR SD-3 IN THE CANAL (ITC) HEARING AID
K935331 · ESD
Nu-Ear Electronics
Ear, Nose, Throat · 77d
Cleared Jan 21, 1994
NU.EAR AE-1 IN THE EAR (ITE) HEARING AID
K935332 · ESD
Nu-Ear Electronics
Ear, Nose, Throat · 77d
Cleared Jan 21, 1994
NU.EAR SS-1 IN THE EAR (ITE) HEARING AID
K935333 · ESD
Nu-Ear Electronics
Ear, Nose, Throat · 77d
Cleared Jan 21, 1994
NU.EAR SD-1 IN THE EAR (ITE) HEARING AID
K935334 · ESD
Nu-Ear Electronics
Ear, Nose, Throat · 77d
Cleared Jan 21, 1994
NU.EAR SS-10 IN THE CANAL (ITC) HEARING AID
K935335 · ESD
Nu-Ear Electronics
Ear, Nose, Throat · 77d
Cleared Jan 14, 1994
FONIX 3500 HEARING AID ANALYZER
K935400 · ETW
Frye Electronics, Inc.
Ear, Nose, Throat · 66d
Cleared Jan 13, 1994
BINAURAL HEARING AID
K935366 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 70d
Cleared Jan 05, 1994
XOMED-TREACE RIGID ROD LENS ENDOSCOPE
K933105 · EOB
Xomed-Treace, Inc.
Ear, Nose, Throat · 194d
Cleared Jan 05, 1994
AUDIPHON, MODEL H-11
K935458 · ESD
National Hearing Aid Dist., Inc.
Ear, Nose, Throat · 54d