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
2809–2832 of 3,798
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Nov 13, 1986
MODEL AK 8184 CUSTOM-LOW-PROFILE HEARING AID
K864031 · ESD
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 29d
Cleared Nov 07, 1986
CUSTOM IN-THE-EAR
K863975 · ESD
Gn Danavox, Inc.
Ear, Nose, Throat · 24d
Cleared Nov 05, 1986
WIDEX HEARING AID MODEL ES2
K864097 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 15d
Cleared Nov 05, 1986
INTEGRA, CUSTOM IN-THE-EAR HEARING AID
K864180 · ESD
Bernafon, Inc.
Ear, Nose, Throat · 9d
Cleared Nov 03, 1986
MIDDLE EAR ANALYZER (IMPEDANCE AUDIOMETER)
K863353 · ETY
Grason-Stadler, Inc.
Ear, Nose, Throat · 66d
Cleared Oct 24, 1986
UNITRON MODEL UL21 HEARING AID
K863225 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 64d
Cleared Oct 17, 1986
STUDEX EAR PIERCING GUNS
K860622 · JYS
Onyx Industries, Inc.
Ear, Nose, Throat · 240d
Cleared Oct 15, 1986
OTICON I31 INITIALES HEARING AID
K862981 · ESD
Oticon Corp.
Ear, Nose, Throat · 69d
Cleared Oct 14, 1986
PA EQUALIZER
K863787 · ESD
Electone, Inc.
Ear, Nose, Throat · 18d
Cleared Oct 09, 1986
PHONIC EAR, MODEL PE475R
K862773 · EPF
Phonic Ear, Inc.
Ear, Nose, Throat · 79d
Cleared Oct 07, 1986
CANNON NASAL SPLINT
K863382 · EPP
Treace Medical, Inc.
Ear, Nose, Throat · 34d
Cleared Sep 19, 1986
NOZEES NOSTRIL DILATOR
K862406 · LWF
Nozees Co.
Ear, Nose, Throat · 86d
Cleared Sep 16, 1986
PHOENIX SYSTEM SEVEN.
K862592 · EWO
Nicolet Biomedical Instruments
Ear, Nose, Throat · 70d
Cleared Sep 12, 1986
WEARABLE TWENTY-FOUR CHANNEL VIBROTACTILE VOCODER
K862471 · LRA
Institute of Logopedics
Ear, Nose, Throat · 74d
Cleared Sep 04, 1986
MODEL 8-B WITH OS-1 ATTACHMENT (C02 LASER FOR ENT)
K862150 · EWG
Directed Energy, Inc.
Ear, Nose, Throat · 92d
Cleared Aug 29, 1986
J.K. TEMPLETON EAR PIERCING GUNS/INSTRUMENTS/STUDS
K860678 · JYS
Jay Kenny Templeton
Ear, Nose, Throat · 185d
Cleared Aug 29, 1986
LASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM/CO2 LASER
K862005 · EWG
Laserscope
Ear, Nose, Throat · 94d
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