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
1849–1872 of 3,798
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Mar 16, 1994
NU-VOIS BATTERY POWERED ARTIFICIAL LARYNX
K934483 · ESE
Mountain Precision Mfg. Ltd. Co.
Ear, Nose, Throat · 183d
Cleared Mar 07, 1994
RESOLUTION(TM) HIP STEM
K933570 · LJW
Wrightmedicaltechnologyinc
Ear, Nose, Throat · 227d
Cleared Mar 07, 1994
MIRACLE-EAR ENTRE
K934940 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 140d
Cleared Mar 04, 1994
MEROCEL(R) TURBINATE GLOVE AND SEPTAL SPLINT
K935658 · LYA
Merocel Corp.
Ear, Nose, Throat · 100d
Cleared Mar 04, 1994
PRIZM HEARING SYSTEM, MODEL POWER BTE
K936007 · ESD
Audioscience, Inc.
Ear, Nose, Throat · 78d
Cleared Feb 22, 1994
PIN HOLDERS, TRANSFIXING PINS, OL WIRES, HALF PINS
K932853 · JEL
Applied Osteo Systems, Inc.
Ear, Nose, Throat · 257d
Cleared Feb 22, 1994
MEDNEXT BUR
K935584 · EQJ
Mednext, Inc.
Ear, Nose, Throat · 96d
Cleared Feb 18, 1994
OTOACOUSTIC EMISSIONS UNIT CELESTA 503
K931325 · EWO
Madsen Electronics (Canada) , Ltd.
Ear, Nose, Throat · 339d
Cleared Feb 16, 1994
ASPIRATING ENDO OCULAR PROBE
K930123 · EQH
Surgical Technologies, Inc.
Ear, Nose, Throat · 400d
Cleared Feb 09, 1994
ARTISAN PROGRAMMER & HEARING AID
K935048 · LRB
Telex Communications, Inc.
Ear, Nose, Throat · 111d
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