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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Ear, Nose, Throat ×
3,805 results
2905–2928 of 3,805
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Mar 12, 1986
A & M DISCREET - HEARING AID
K860190 · ESD
Electone, Inc.
Ear, Nose, Throat · 49d
Cleared Mar 12, 1986
PA PRESIDENTIAL II - HEARING AID
K860191 · ESD
Electone, Inc.
Ear, Nose, Throat · 49d
Cleared Mar 12, 1986
A & M 150 PP (HEARING AID)
K860244 · ESD
Electone, Inc.
Ear, Nose, Throat · 47d
Cleared Mar 04, 1986
DAHLBERG MODEL KC IN-THE-EAR HEARING AID
K854834 · ESD
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 91d
Cleared Mar 04, 1986
DAHLBERG MODEL GF MICROPROCESSOR AUDIOMETER
K854835 · EWO
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 91d
Cleared Feb 28, 1986
MACHIDA SEMI-RIGID BRONCHOSCOPE FBS-6R-50
K854581 · EOQ
Machida America, Inc.
Ear, Nose, Throat · 105d
Cleared Feb 28, 1986
ZIMMER VIDEO PRODUCTS AUTOMATIC LIGHT SOURCE
K854751 · EQH
Aspen Laboratories, Inc.
Ear, Nose, Throat · 94d
Cleared Feb 24, 1986
THE ANSWER HEARING AID
K854438 · ESD
Electone, Inc.
Ear, Nose, Throat · 111d
Cleared Feb 20, 1986
INSERTION GAIN OPTIMIZER IGO-1000
K854535 · ETW
Madsen Electronics (Canada) , Ltd.
Ear, Nose, Throat · 99d
Cleared Feb 20, 1986
OTICON, CITEC CUSTOM MADE HEARING AID CANAL TYPE
K854742 · ESD
Oticon Corp.
Ear, Nose, Throat · 87d
Cleared Feb 14, 1986
LARYNGASCOPES, FORCEPS, MICRO SUCTION TUBE & REFLE
K853708 · KAE
Downs Surgical , Ltd.
Ear, Nose, Throat · 163d
Cleared Feb 13, 1986
PORTALASE 300 CARBON DIOXIDE SURG LASER EAR/NOSE/T
K854471 · EWG
Minnesota Laser Corp.
Ear, Nose, Throat · 99d
Cleared Feb 13, 1986
DIGITAL SCREENING AUDIOMETER DSA6214
K854534 · EWO
Madsen Electronics (Canada) , Ltd.
Ear, Nose, Throat · 92d
Cleared Jan 21, 1986
HEARTECH MODEL IN TECH
K854315 · ESD
Hearing Tech, Inc.
Ear, Nose, Throat · 85d
Cleared Jan 21, 1986
MICRO-AIRE OTO/NEURO DRILL SYSTEM
K854331 · ERL
Micro-Aire Surgical Instruments, Inc.
Ear, Nose, Throat · 85d
Cleared Jan 21, 1986
MICRO-AIRE STAPES DRILL SYSTEM
K854332 · ERL
Micro-Aire Surgical Instruments, Inc.
Ear, Nose, Throat · 85d
Cleared Jan 16, 1986
HEARING AID ANALYSIS SYSTEM
K853271 · ETW
Robert Bosch Corp.
Ear, Nose, Throat · 164d
Cleared Jan 16, 1986
CRAIGWELL AID FITTING SYSTEM AFS
K854125 · EWO
Craigwell Electronics, Ltd.
Ear, Nose, Throat · 99d
Cleared Jan 16, 1986
CRAIGWELL MASTER HEARING AID MHA
K854126 · KHL
Craigwell Electronics, Ltd.
Ear, Nose, Throat · 99d
Cleared Jan 09, 1986
ENDO-LASE CD-100 CO2 LASER FOR OTORHINOLARYNGOLOGY
K853875 · EWG
Endo Lase, Inc.
Ear, Nose, Throat · 114d
Cleared Jan 09, 1986
ENDO-LASE CD40 FOR OTORHINOLARYNGOLOGY
K853902 · EWG
Endo Lase, Inc.
Ear, Nose, Throat · 111d
Cleared Jan 06, 1986
GOODE T-TUBE WHITE SILICONE TYMPANOSTOMY TUBE
K852387 · ETD
Xomed, Inc.
Ear, Nose, Throat · 215d
Cleared Jan 06, 1986
GODDE T-TUBE BLUE SILICONE TYMPANOSTOMY TUBE
K853641 · ETD
Xomed, Inc.
Ear, Nose, Throat · 125d
Cleared Dec 31, 1985
CERTI-FORM
K854001 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 92d