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
1681–1704 of 3,798
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Nov 22, 1994
WANG BRONCHIAL NEEDLE BRUSH
K944650 · EOQ
Mill-Rose Laboratory
Ear, Nose, Throat · 62d
Cleared Nov 22, 1994
KARL STORZ INSULATED CANNULAE, SUCTION TUBES
K944797 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 55d
Cleared Nov 22, 1994
MICROMED PARTIAL REGULAR AND PARTIAL OFFSET
K945104 · ETB
Micromed Development Corp.
Ear, Nose, Throat · 35d
Cleared Nov 22, 1994
MICROMED TOTAL REGULAR AND PARTIAL OFFSET
K945106 · ETA
Micromed Development Corp.
Ear, Nose, Throat · 35d
Cleared Nov 22, 1994
POLY-WIRE PISTON
K945107 · ETB
Micromed Development Corp.
Ear, Nose, Throat · 35d
Cleared Nov 22, 1994
POLY PISTON
K945108 · ETB
Micromed Development Corp.
Ear, Nose, Throat · 35d
Cleared Nov 22, 1994
EDI-BUR MICRODRILL SYSTEMS
K945438 · ERL
Micromed Development Corp.
Ear, Nose, Throat · 33d
Cleared Nov 18, 1994
OTOVIEW TELESCOPIC OTOSCOPES
K943721 · ERA
Smith & Nephew, Inc.
Ear, Nose, Throat · 109d
Cleared Nov 18, 1994
APEX UNIVERSAL DRIVE SYSTEM
K944476 · ERL
Linvatec Corp.
Ear, Nose, Throat · 67d
Cleared Nov 16, 1994
MAGNATONE MODEL M PREWIRED FACEPLATE HEARING AID
K944241 · ESD
Magnatone Hearing Aid Corp.
Ear, Nose, Throat · 77d
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