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
1321–1344 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Oct 18, 1996
RAND NASAL PACKING
K963856 · EMX
Rand Scientific Corp.
Ear, Nose, Throat · 23d
Cleared Oct 16, 1996
HF MEGA EAR
K960567 · EPF
Maxi-Aids, Inc.
Ear, Nose, Throat · 250d
Cleared Oct 10, 1996
PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESIS
K963752 · ETB
Grace Medical, Inc.
Ear, Nose, Throat · 22d
Cleared Oct 08, 1996
CCA-100 (MODIFIED)
K963681 · EWO
Benson Medical Instruments Co.
Ear, Nose, Throat · 89d
Cleared Sep 27, 1996
EUROLINE A-675 SERIS
K963519 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 24d
Cleared Sep 27, 1996
DYNAMIC EQ II - 2 CHANNEL WIDE DYNAMIC RANGE COMPRESSION
K963604 · ESD
Midwest City Hearing Aid Center
Ear, Nose, Throat · 18d
Cleared Sep 23, 1996
TREBAY MICRODEBRIDER OR XPS STRAIGHT SHOT
K963246 · ERL
Medtronic Xomed
Ear, Nose, Throat · 35d
Cleared Sep 20, 1996
TBAN
K963252 · EOQ
Boston Scientific Corp
Ear, Nose, Throat · 32d
Cleared Sep 20, 1996
HORIZON 1 AND 2 PROGRAMABLE FULL SHELL AND IN THE CANAL
K963607 · ESD
Midwest City Hearing Aid Center
Ear, Nose, Throat · 11d
Cleared Sep 16, 1996
IN THE EAR HEARING AID
K962388 · ESD
Unique Hearing Technology, Inc.
Ear, Nose, Throat · 88d
Cleared Sep 11, 1996
CLARUS MURPHYPEN ENDOSCOPE(2127-XXX)
K962255 · EOB
Clarus Medical Systems, Inc.
Ear, Nose, Throat · 91d
Cleared Sep 10, 1996
AIR-CONDUCTION HEARING INSTRUMENTS: MODELS = 227, 229, 232, 216, 216P, 123,...
K963047 · ESD
Fenwick Hearing Instruments
Ear, Nose, Throat · 43d
Cleared Sep 09, 1996
AIR MAX EXTERNAL NASAL DILATOR STRIP
K962400 · LWF
American White Cross, Inc.
Ear, Nose, Throat · 80d
Cleared Sep 09, 1996
ACUTEK'S CLEARPASAGE
K962698 · LWF
Acutek Adhesive Specialties, Inc.
Ear, Nose, Throat · 84d
Cleared Sep 09, 1996
AUDIO 'D' K-AMP HR FULL SHELL AND CANAL HEARING AIDS
K962798 · ESD
Hearing Solutions, Inc.
Ear, Nose, Throat · 53d
Cleared Sep 09, 1996
SUSTAINED PHONATION
K962961 · KTH
Surface Mount Technology, Inc.
Ear, Nose, Throat · 41d
Cleared Sep 09, 1996
BF 240/P240/IT240 BRONCHOVIDEOSCOPE & ACCESSORIES
K963033 · EOQ
Olympus America, Inc.
Ear, Nose, Throat · 35d
Cleared Sep 06, 1996
UNITRON MODEL ICON KR
K963122 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 25d
Cleared Sep 05, 1996
MAICO MA25 SERIES II WITH SPEECH
K962275 · EWO
Bernafon-Maico, Inc.
Ear, Nose, Throat · 84d
Cleared Sep 05, 1996
RIONET HB-55AS
K963152 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 23d
Cleared Sep 05, 1996
RIONET HB-55S
K963153 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 23d
Cleared Sep 05, 1996
RIONET HB-54AS
K963154 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 22d
Cleared Aug 28, 1996
MODEL ALPHA BEHIND-THE-EAR HEARING INSTRUMENT
K962228 · ESD
Ototech Intl., Inc.
Ear, Nose, Throat · 79d
Cleared Aug 27, 1996
KSEA BIPOLAR GOAGULATING FORCEPS
K962396 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 67d