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
1705–1728 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Nov 15, 1994
DANAVOX MODEL CIC
K942331 · ESD
Gn Danavox, Inc.
Ear, Nose, Throat · 183d
Cleared Nov 15, 1994
COMPASS SOFTWARE MODULE
K944097 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 85d
Cleared Nov 14, 1994
REXPLUS PP3
K944548 · ESD
Rexton, Inc.
Ear, Nose, Throat · 59d
Cleared Nov 08, 1994
HOME CARE EAR EXAMINATIO KIT
K944897 · ERA
Home Care Instruments, Inc.
Ear, Nose, Throat · 35d
Cleared Nov 07, 1994
SINUSCOPE
K944186 · EOB
Stryker Endoscopy
Ear, Nose, Throat · 73d
Cleared Oct 31, 1994
AUDITORY CASSETTE
K941834 · KLW
Ltmlt, Inc.
Ear, Nose, Throat · 201d
Cleared Oct 21, 1994
DESKREM-1000
K943459 · ETW
Starkey Laboratories, Inc.
Ear, Nose, Throat · 95d
Cleared Oct 21, 1994
PORTAREM 2000
K943460 · ETW
Starkey Laboratories, Inc.
Ear, Nose, Throat · 95d
Cleared Oct 21, 1994
PROGRAM 3-CH SER HEAR AIDS W/PROGRAM FIT SYST/PRO FIT
K944078 · ESD
Argosy Electronics
Ear, Nose, Throat · 60d
Cleared Oct 20, 1994
FEDELITY F495, VIENNATONE ALPP II
K943687 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 83d
Cleared Oct 20, 1994
UV CURED METHYL METHACRYLATE HEARING AID SHELL MATERIALS
K943960 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 66d
Cleared Oct 20, 1994
BELTONE CONCERTO S
K944502 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 36d
Cleared Oct 20, 1994
WIDEX MODEL LX-ITE
K944838 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 20d
Cleared Oct 14, 1994
RIGID TELESCOPES
K943904 · ENZ
Karl Storz Endoskop GmbH
Ear, Nose, Throat · 64d
Cleared Oct 14, 1994
KARL STORZ OPTICAL VIDEO TONGUE DEPRESSOR
K944296 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 42d
Cleared Oct 12, 1994
PROGRAM 3-CH SERIES HEAR AIDS W/DT-1 DESKTOP PROGRAM
K944077 · ESD
Argosy Electronics
Ear, Nose, Throat · 51d
Cleared Oct 11, 1994
TYMPANOSTOMY TUBE
K943325 · ETD
Grace Medical, Inc.
Ear, Nose, Throat · 92d
Cleared Oct 11, 1994
NASAL ENDOSCOPY & SINUSCOPY HAND INSTRUMENTS
K943665 · EOB
Olympus America, Inc.
Ear, Nose, Throat · 75d
Cleared Oct 11, 1994
VIDEO OTOSCOPE
K943731 · ERA
Cuda Products Co.
Ear, Nose, Throat · 70d
Cleared Sep 23, 1994
MIRACLE-EAR IMPRESSION MATERIAL KIT
K942523 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 161d
Cleared Sep 23, 1994
INTERACOUSTICS HEARING AID ANALYZER MS 40
K943607 · ETW
Precision Acoustics Ind., Inc.
Ear, Nose, Throat · 60d
Cleared Sep 23, 1994
MIRACLE-EAR MIRAGE
K943826 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 49d
Cleared Sep 23, 1994
VIDEO SCOPE SYSTEM (OTOSCOPE)
K944031 · ERA
Jedmed Instrument Co.
Ear, Nose, Throat · 37d
Cleared Sep 21, 1994
RESOUND PERSONAL HEARING SYSTEM
K943788 · ESD
Resound Corp.
Ear, Nose, Throat · 49d