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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Ear, Nose, Throat ×
3,805 results
2833–2856 of 3,805
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Aug 26, 1986
OTICON I31 CITE HEARING AID
K862980 · ESD
Oticon Corp.
Ear, Nose, Throat · 19d
Cleared Aug 15, 1986
HA-2000 REAL EAR SPECTROSCOPE
K862026 · ETW
And/Or Corp.
Ear, Nose, Throat · 79d
Cleared Aug 15, 1986
AUDIOMETER/MASTER HEARING AID MF6
K862770 · EWO
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 24d
Cleared Aug 15, 1986
TREACE DRILL SYSTEM
K862807 · ERL
Treace Medical, Inc.
Ear, Nose, Throat · 23d
Cleared Aug 13, 1986
FACEPLATE, CUSTOM IN-THE-EAR HEARING AID, MCA10
K862768 · LRB
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 22d
Cleared Aug 13, 1986
FACEPLATE, CUSTOM IN-THE-EAR HEARING AID, FPR
K862769 · LRB
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 22d
Cleared Aug 08, 1986
D.L. SCOPE(R) OTOSCOPE
K862661 · ERA
North American Medical Products, Inc.
Ear, Nose, Throat · 25d
Cleared Aug 07, 1986
I81 INITIALES
K862623 · ESD
Oticon Corp.
Ear, Nose, Throat · 28d
Cleared Aug 01, 1986
I22 INITIALES
K862621 · ERA
Oticon Corp.
Ear, Nose, Throat · 22d
Cleared Aug 01, 1986
I22 CITE
K862622 · ESD
Oticon Corp.
Ear, Nose, Throat · 22d
Cleared Aug 01, 1986
I81 CITE
K862624 · ERA
Oticon Corp.
Ear, Nose, Throat · 22d
Cleared Aug 01, 1986
CUSTOM IN-THE-EAR AND CANAL HEARING AID
K862754 · ESD
Cochlear Laboratories, Ltd.
Ear, Nose, Throat · 10d
Cleared Jul 31, 1986
RIONET HEARING AID HB-35PT
K862670 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 17d
Cleared Jul 31, 1986
HEARING AID, UNITRON MODEL UF11
K862760 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 9d
Cleared Jul 22, 1986
ALPHA ALL-IN-THE-EAR HEARING AID
K862169 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 43d
Cleared Jul 22, 1986
PHONIC EAR PE 602 PPCS
K862229 · ESD
Phonic Ear, Inc.
Ear, Nose, Throat · 41d
Cleared Jul 18, 1986
MODEL 545-45 LASER FOR EAR, NOSE & THROAT
K860975 · EWG
Britt Corp., Inc.
Ear, Nose, Throat · 126d
Cleared Jul 18, 1986
PHONIC EAR, MODEL PE 1800
K862162 · ETW
Phonic Ear, Inc.
Ear, Nose, Throat · 42d
Cleared Jul 16, 1986
IN SITU EAR GAIN AUDIO TEST STAT TYPE 2118/WH 1823
K862086 · ETW
A/S Bruel & Kjaer
Ear, Nose, Throat · 44d
Cleared Jul 16, 1986
INEARSET IES HEARING AID
K862222 · ESD
Inearset, Inc.
Ear, Nose, Throat · 35d
Cleared Jul 16, 1986
HEARING AID (ALL-IN-EAR)
K862545 · ESD
Vibrasonic, Inc.
Ear, Nose, Throat · 13d
Cleared Jul 14, 1986
INCUS/STAPES PROSTHESIS
K861369 · ETB
Richards Medical Co., Inc.
Ear, Nose, Throat · 94d
Cleared Jul 14, 1986
MICROTEK INTRANASAL SPLINT
K862496 · EPP
Microtek Medical, Inc.
Ear, Nose, Throat · 13d
Cleared Jul 14, 1986
MICROTEK SEPTAL BUTTON
K862497 · LFB
Microtek Medical, Inc.
Ear, Nose, Throat · 13d