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
2233–2256 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Oct 24, 1991
OES THORACOSCOPE SYSTEM
K912362 · EWY
Olympus Corp.
Ear, Nose, Throat · 148d
Cleared Oct 23, 1991
PROGRAMMABLE AUDITORY COMPARATOR, MODIFICATION
K911726 · KHL
Bausch & Lomb, Inc.
Ear, Nose, Throat · 195d
Cleared Oct 21, 1991
MODEL 330 SCREENING AUDIOMETER
K911689 · EWO
Virtual Corp.
Ear, Nose, Throat · 188d
Cleared Oct 21, 1991
MICROTEK MEDICAL'S SOUND STIKS
K913276 · EWO
Microbio-Medics, Inc.
Ear, Nose, Throat · 90d
Cleared Oct 21, 1991
ACT-II BEHIND THE EAR HEARING AID
K914418 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 18d
Cleared Oct 21, 1991
AUDIOTONE MODEL A-95 BEHIND-THE-EAR HEARING AID
K914477 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 13d
Cleared Oct 18, 1991
MODEL 80 HEARING AID DISPENSING SYSTEM
K913245 · ESD
3M Company
Ear, Nose, Throat · 88d
Cleared Oct 17, 1991
PEDIA PALS
K911650 · ERA
Pedia Pals, Inc.
Ear, Nose, Throat · 188d
Cleared Oct 15, 1991
CERAVITAL MIDDLE EAR IMPLANT
K913619 · ETB
Friedrichsfeld Medizintechnik AG
Ear, Nose, Throat · 63d
Cleared Oct 11, 1991
TYPE FA10 AUDIOMETER
K913221 · EWO
Frye Electronics, Inc.
Ear, Nose, Throat · 84d
Cleared Oct 11, 1991
SIEMENS MODEL LS-I W/INFINITI PROGRAMMABLE OPTION
K914333 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 14d
Cleared Sep 24, 1991
PROTECTED BRONCHOALVEOLAR LAVAGE BALLOON CATHETER
K910536 · EOQ
Mill-Rose Laboratory
Ear, Nose, Throat · 228d
Cleared Sep 24, 1991
DONALDSON/SHEPARDS DR/COLLAR/SHAH VENT-MINI TUBES
K911580 · ETD
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 174d
Cleared Sep 23, 1991
UC312, ULTRA MINIATURE ITC HEARING AID
K914017 · ESD
Qualitone
Ear, Nose, Throat · 14d
Cleared Sep 18, 1991
QUALITONE 46PP-AGC-I
K913592 · ESD
Qualitone
Ear, Nose, Throat · 37d
Cleared Sep 18, 1991
ELEGANCE - KED, BEHIND THE EAR HEARING AID
K913771 · ESD
Qualitone
Ear, Nose, Throat · 27d
Cleared Sep 18, 1991
QUALITONE 48PP-AGC-I, BEHIND THE EAR HEARING AID
K913781 · ESD
Qualitone
Ear, Nose, Throat · 34d
Cleared Sep 17, 1991
HEARING CHECKER(TM), DESKTOP MODEL
K904622 · EWO
Qualitone Hearing Aids and Audiometers
Ear, Nose, Throat · 341d
Cleared Sep 16, 1991
RESOUND PORTABLE PRESCRIPTIVE PROGRAMMING SYSTEM
K912669 · EWO
Resound Corp.
Ear, Nose, Throat · 90d
Cleared Sep 09, 1991
IONOS(R) OSSICLE 5MM & 7MM
K911583 · ETA
Ionos GmbH & Co. KG
Ear, Nose, Throat · 154d
Cleared Sep 06, 1991
PHONAK AUDINET PP-C-P BTE HEARING INSTRUMENT
K913502 · ESD
Phonak, Inc.
Ear, Nose, Throat · 30d
Cleared Sep 06, 1991
PHONAK PICO-FORTE PP-C-P BTE HEARING INSTRUMENT
K913503 · ESD
Phonak, Inc.
Ear, Nose, Throat · 30d
Cleared Aug 30, 1991
KAPS 90 DEGREE FIBEROPTIC ADAPTOR
K912885 · EQH
Jedmed Instrument Co.
Ear, Nose, Throat · 60d
Cleared Aug 26, 1991
PHILIPS S1594 OTB HEARING AID
K913389 · ESD
Philips Hearing Instruments Co.
Ear, Nose, Throat · 28d