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
1153–1176 of 3,798
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Aug 22, 1997
CAUSSE UNIVERSAL OSSICULAR REPLACEMENT PROSTHESIS (ORP/1)
K963899 · ETA
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 329d
Cleared Aug 18, 1997
EARCHECK
K971859 · ETY
Mdi Instruments, Inc.
Ear, Nose, Throat · 90d
Cleared Aug 15, 1997
HEARTLAND TECHNOLOGIES, ITE, ITC, CIC
K971845 · ESD
Sound Hearing Instruments, Inc.
Ear, Nose, Throat · 88d
Cleared Aug 15, 1997
AIR CONDUCTION HAEARING AIDS
K971852 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 87d
Cleared Aug 15, 1997
LORIPRO, LORIPRO II
K972058 · ESD
Lori Medical Laboratories, Inc.
Ear, Nose, Throat · 74d
Cleared Aug 15, 1997
PHONAK NOVO FORTE E3
K972106 · ESD
Phonak, Inc.
Ear, Nose, Throat · 71d
Cleared Aug 07, 1997
IN THE EAR, IN THE CANAL, COMPLETELY IN THE CANAL
K971807 · ESD
Hear-Right, Inc.
Ear, Nose, Throat · 84d
Cleared Aug 05, 1997
AMPLAID 460
K971747 · EWO
Amplifon S.P.A.
Ear, Nose, Throat · 85d
Cleared Aug 05, 1997
V-12 LONG LIFE 675 HEARING AID
K972755 · ESD
Vista Labs
Ear, Nose, Throat · 14d
Cleared Aug 04, 1997
RHINOCELL NASAL PACKINGS
K972459 · EMX
Boston Medical Products, Inc.
Ear, Nose, Throat · 34d
Cleared Aug 04, 1997
BELL PROSTHESIS (PARTIAL)
K972492 · ETB
Heinz Kurz
Ear, Nose, Throat · 33d
Cleared Aug 04, 1997
AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL DUSSELDORF, DRESDEN AERIAL...
K972585 · ETA
Heinz Kurz GmbH Medizintechnik
Ear, Nose, Throat · 25d
Cleared Aug 01, 1997
PHONAK EPICA
K972105 · ESD
Phonak, Inc.
Ear, Nose, Throat · 57d
Cleared Jul 31, 1997
AUDIFON H24 AGC/AUDIFON H25 AGC/AUDIFON H30 AGC
K972550 · ESD
Trutone
Ear, Nose, Throat · 31d
Cleared Jul 30, 1997
PHONAK MICROZOOM P 2
K972097 · ESD
Phonak, Inc.
Ear, Nose, Throat · 56d
Cleared Jul 30, 1997
AUDIFON H20 PC/AUDIFON H32 PP
K972552 · ESD
Trutone
Ear, Nose, Throat · 30d
Cleared Jul 29, 1997
MYRINGOTOMY TUBE
K972126 · ETD
Mednet Locator, Inc.
Ear, Nose, Throat · 54d
Cleared Jul 29, 1997
OVATION HDP
K972373 · ESD
Orsonique, Inc.
Ear, Nose, Throat · 34d
Cleared Jul 23, 1997
BETTER HEARING, INC. MODEL L-1 HEARING AID
K971298 · ESD
Better Hearing, Inc.
Ear, Nose, Throat · 107d
Cleared Jul 23, 1997
MYRINGOTOMY TUBE
K971943 · ETD
Mednet Locator, Inc.
Ear, Nose, Throat · 57d
Cleared Jul 23, 1997
MIRACLE-EAR DIGITAL BTE
K972344 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 29d
Cleared Jul 23, 1997
DAHLBERG/MIRACLE-EAR
K972345 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 29d
Cleared Jul 23, 1997
MIRACLE-EAR ITE DIGITAL
K972346 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 29d
Cleared Jul 23, 1997
MYRINGOTOMY TUBE - BOBBIN WITH TAB
K972400 · ETD
Mednet Locator, Inc.
Ear, Nose, Throat · 48d