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
1777–1800 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Jul 20, 1994
GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHT
K941662 · EQH
Gm Engineering, Inc.
Ear, Nose, Throat · 106d
Cleared Jul 20, 1994
HAE 1
K942829 · ESD
Hearing Aid Express
Ear, Nose, Throat · 36d
Cleared Jul 20, 1994
HAE 3
K942830 · ESD
Hearing Aid Express
Ear, Nose, Throat · 36d
Cleared Jul 20, 1994
HAE 2
K942831 · ESD
Hearing Aid Express
Ear, Nose, Throat · 36d
Cleared Jul 20, 1994
AURIS CIC
K943144 · ESD
General Hearing Instruments, Inc.
Ear, Nose, Throat · 21d
Cleared Jul 18, 1994
XOMED-TREACE SCOPESHEATH
K933672 · EOB
Xomed-Treace, Inc.
Ear, Nose, Throat · 355d
Cleared Jul 18, 1994
RICHARD ROD LENS LARYNGOSCOPE
K941264 · EOQ
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 124d
Cleared Jul 18, 1994
HI-PRO/NOAH UNIVERSAL HEARING INSTRUMENT
K942749 · ESD
Madsen Electronics (Canada) , Ltd.
Ear, Nose, Throat · 38d
Cleared Jul 08, 1994
EXTERNAL NASAL SPLINT
K942724 · EPP
Micromed Development Corp.
Ear, Nose, Throat · 29d
Cleared Jul 07, 1994
DAIL A HEARING SCREENING TEST
K935719 · EWO
Occupational Hearing Services
Ear, Nose, Throat · 219d
Cleared Jul 06, 1994
MODEL#1550 MARSONA(R) TINNITUS MASKER
K940567 · KLW
Marpac, Inc.
Ear, Nose, Throat · 148d
Cleared Jul 05, 1994
STAR 42 PP SP STAR 42 DIGITALLY PROGRAMMABLE HEARING AID
K942594 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 34d
Cleared Jul 01, 1994
BIVONA NASAL TURBINATE STENT
K935053 · LYA
Bivona Medical Technologies
Ear, Nose, Throat · 253d
Cleared Jun 29, 1994
SUPER-SIL
K940164 · ESD
Finetone Hearing Instruments
Ear, Nose, Throat · 174d
Cleared Jun 24, 1994
FLUOROFILM(R)
K933800 · EMX
American Custom Medical, Inc.
Ear, Nose, Throat · 324d
Cleared Jun 24, 1994
HEARING TECH
K941587 · ESD
Hearing Tech, Inc.
Ear, Nose, Throat · 85d
Cleared Jun 24, 1994
PHONAK MICROVOX RESONAL FM SYSTEM
K941768 · EPF
Phonak, Inc.
Ear, Nose, Throat · 74d
Cleared Jun 24, 1994
EUROSTAR SUPER, EUROSTAR VFC
K942036 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 57d
Cleared Jun 24, 1994
REPLACEMENT BATTERIES/WELCH ALLYN #72200 POWER HANDLE
K942244 · ERA
National Custom Ent., Inc.
Ear, Nose, Throat · 87d
Cleared Jun 22, 1994
PROVOX(TM) VOICE PROSTHESIS
K940638 · EWL
Atos Medical AB
Ear, Nose, Throat · 128d
Cleared Jun 21, 1994
SAPHIRE PLUS SURGICAL MIRROR
K934911 · EQH
San Diego Swiss Machining, Inc.
Ear, Nose, Throat · 250d
Cleared Jun 20, 1994
INTERACOUSTICS DIAGNOSTIC AUDIOMETER
K942006 · EWO
Precision Acoustics Ind., Inc.
Ear, Nose, Throat · 56d
Cleared Jun 17, 1994
SHARP II HELIX HEARING AID
K941295 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 92d
Cleared Jun 17, 1994
PHILIPS 61 SERIES
K942164 · ESD
Philips Hearing Instruments Co.
Ear, Nose, Throat · 44d