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
1681–1704 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Dec 21, 1994
IMAGE
K944161 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 117d
Cleared Dec 21, 1994
BIO-LOGIC EMAV EMISSION AVERAGING OTOACOUSTIC TEST
K944735 · EWO
Bio-Logic Systems Corp.
Ear, Nose, Throat · 86d
Cleared Dec 21, 1994
BRONCHOSCOPE,NON-RIGID
K944976 · EOQ
Citation Medical Corp.
Ear, Nose, Throat · 71d
Cleared Dec 21, 1994
ACTIVE MODEL CIC
K945218 · ESD
Active Electronics, Inc.
Ear, Nose, Throat · 56d
Cleared Dec 21, 1994
KARL STORZ SUCTYION/IRRIGATION TUBES, CANNULAE
K945237 · EOX
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 55d
Cleared Dec 21, 1994
FINETONE DISCEET CANAL
K945780 · ESD
Finetone Hearing Instruments
Ear, Nose, Throat · 26d
Cleared Dec 14, 1994
ADOBE C.I.C
K943016 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 173d
Cleared Dec 09, 1994
INHEALTH BLOM-SINGER INDWELLING VALVED INSERT ACCESSORY DEVICE
K945287 · EWL
Helix Medical, Inc.
Ear, Nose, Throat · 39d
Cleared Dec 02, 1994
INHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICE
K945288 · EWL
Helix Medical, Inc.
Ear, Nose, Throat · 32d
Cleared Nov 30, 1994
MILL-ROSE HARRELL BRONCHIAL BRUSH
K944649 · EOQ
Mill-Rose Laboratory
Ear, Nose, Throat · 70d
Cleared Nov 29, 1994
MICROSIL
K945255 · ESD
Microsonic, Inc.
Ear, Nose, Throat · 32d
Cleared Nov 22, 1994
ELECTRIC SURGICAL DRILL
K940016 · ERL
Alamo City Dental Supply Co.
Ear, Nose, Throat · 322d
Cleared Nov 22, 1994
HEARING AID (ACCESSORY)
K944009 · ESD
Phoenix Management, Inc.
Ear, Nose, Throat · 98d
Cleared Nov 22, 1994
KARL STORZ INSULATED SCISSORS
K944298 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 77d
Cleared Nov 22, 1994
WANG BRONCHIAL NEEDLE BRUSH
K944650 · EOQ
Mill-Rose Laboratory
Ear, Nose, Throat · 62d
Cleared Nov 22, 1994
KARL STORZ INSULATED CANNULAE, SUCTION TUBES
K944797 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 55d
Cleared Nov 22, 1994
MICROMED PARTIAL REGULAR AND PARTIAL OFFSET
K945104 · ETB
Micromed Development Corp.
Ear, Nose, Throat · 35d
Cleared Nov 22, 1994
MICROMED TOTAL REGULAR AND PARTIAL OFFSET
K945106 · ETA
Micromed Development Corp.
Ear, Nose, Throat · 35d
Cleared Nov 22, 1994
POLY-WIRE PISTON
K945107 · ETB
Micromed Development Corp.
Ear, Nose, Throat · 35d
Cleared Nov 22, 1994
POLY PISTON
K945108 · ETB
Micromed Development Corp.
Ear, Nose, Throat · 35d
Cleared Nov 22, 1994
EDI-BUR MICRODRILL SYSTEMS
K945438 · ERL
Micromed Development Corp.
Ear, Nose, Throat · 33d
Cleared Nov 18, 1994
OTOVIEW TELESCOPIC OTOSCOPES
K943721 · ERA
Smith & Nephew, Inc.
Ear, Nose, Throat · 109d
Cleared Nov 18, 1994
APEX UNIVERSAL DRIVE SYSTEM
K944476 · ERL
Linvatec Corp.
Ear, Nose, Throat · 67d
Cleared Nov 16, 1994
MAGNATONE MODEL M PREWIRED FACEPLATE HEARING AID
K944241 · ESD
Magnatone Hearing Aid Corp.
Ear, Nose, Throat · 77d