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
1153–1176 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Sep 29, 1997
PROMEX ENT TISSUE REMOVAL SYSTEM
K972865 · ERL
Promex, Inc.
Ear, Nose, Throat · 56d
Cleared Sep 29, 1997
ENT IRRIGATING PUMP (70327700)
K973286 · ERL
Gyrus Ent LLC
Ear, Nose, Throat · 27d
Cleared Sep 23, 1997
Z DEQ-II
K973266 · ESD
Electone, Inc.
Ear, Nose, Throat · 25d
Cleared Sep 18, 1997
MONTGOMERY THYROPLASTY IMPLANT SYSTEM
K972317 · MIX
Boston Medical Products, Inc.
Ear, Nose, Throat · 90d
Cleared Sep 08, 1997
K 15 AUDIOMETER
K972221 · EWO
American Electromedics Corp.
Ear, Nose, Throat · 87d
Cleared Sep 08, 1997
DRY & STORE
K972776 · ESD
Ear Technology Corp.
Ear, Nose, Throat · 45d
Cleared Sep 08, 1997
KARL STORZ CONTACT NASAL MICRO-ENDOSCOPES
K972855 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 38d
Cleared Sep 05, 1997
XPS STRAIGHTSHOT MICRORESECTOR
K972453 · ERL
Xomed, Inc.
Ear, Nose, Throat · 67d
Cleared Sep 05, 1997
PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (PORP)
K972734 · ETB
Mednet Locator, Inc.
Ear, Nose, Throat · 45d
Cleared Sep 05, 1997
TOTAL OSSICULAR REPLACEMENT PROSTHESIS (TORP)
K972735 · ETA
Mednet Locator, Inc.
Ear, Nose, Throat · 45d
Cleared Sep 05, 1997
CAUSSE PISTON
K972737 · ETB
Mednet Locator, Inc.
Ear, Nose, Throat · 45d
Cleared Sep 05, 1997
PRISMA
K972998 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 24d
Cleared Aug 27, 1997
OPTICAL MEDIASTINOSCOPE WITH PLUG-IN CONNECTION/OCULAR EYEPIECE
K971166 · EWY
Richard Wolf Medical Instruments Corp.
Ear, Nose, Throat · 149d
Cleared Aug 25, 1997
NEW SOUND HIDDEN AID COMPLETELY IN CANAL (CIC)
K972039 · ESD
Nu-Sound
Ear, Nose, Throat · 84d
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