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
1297–1320 of 3,798
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Nov 07, 1996
KARL STORZ CONTACT MICRO-LARYNGOSCOPES
K963426 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 69d
Cleared Nov 07, 1996
IVALON NASAL PACKING W/DRAWSTRING (8.0CM & 4.5CM), IVALON NASAL PACKING...
K964113 · EMX
M-Pact Worldwide Management Corp.
Ear, Nose, Throat · 23d
Cleared Nov 04, 1996
RESOUND CC4 PERSONAL HEARING SYSTEM
K964115 · ESD
Resound Corp.
Ear, Nose, Throat · 20d
Cleared Nov 01, 1996
RINOFLOW MICRONIZED E.N..T. WASH SYTSTEM
K963550 · KMA
Respironics, Inc.
Ear, Nose, Throat · 57d
Cleared Oct 29, 1996
HEARSAVER
K962292 · EWD
Emtech Laboratories
Ear, Nose, Throat · 137d
Cleared Oct 28, 1996
OVATION AGC-2
K963818 · ESD
Orsonique, Inc.
Ear, Nose, Throat · 35d
Cleared Oct 28, 1996
OVATION ASP
K963819 · ESD
Orsonique, Inc.
Ear, Nose, Throat · 35d
Cleared Oct 28, 1996
OVATION LINEAR
K963820 · ESD
Orsonique, Inc.
Ear, Nose, Throat · 35d
Cleared Oct 28, 1996
OVATION AGC-1
K963821 · ESD
Orsonique, Inc.
Ear, Nose, Throat · 35d
Cleared Oct 28, 1996
OVATION AGC-3
K963822 · ESD
Orsonique, Inc.
Ear, Nose, Throat · 35d
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