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
2545–2568 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Aug 21, 1989
BIOMETER AUDIOMETER
K883505 · EWO
Micro Audiometrics Corp.
Ear, Nose, Throat · 369d
Cleared Aug 21, 1989
AUDITORY TRAINER PE150R FM RECEIVER
K893431 · EPF
Phonic Ear, Inc.
Ear, Nose, Throat · 111d
Cleared Aug 15, 1989
OTICON I22P CUSTOM FULL CONCHA (ITE) HRNG AID
K893528 · ESD
Oticon Corp.
Ear, Nose, Throat · 99d
Cleared Aug 08, 1989
ASTRO BEHIND-THE-EAR HEARING AID
K892898 · ESD
Rexton, Inc.
Ear, Nose, Throat · 110d
Cleared Aug 04, 1989
PERSONAL AMPLIFIER RECHARGEABLE MODEL TRIUMPH II
K893432 · ESD
Electone, Inc.
Ear, Nose, Throat · 94d
Cleared Aug 04, 1989
RESOUND CUSTOM IN-THE CANAL HEARING AID PHS-3
K893927 · ESD
Resound Corp.
Ear, Nose, Throat · 65d
Cleared Aug 03, 1989
BEHIND-THE-EAR HEARING AID MODEL 48 AGCI
K892338 · ESD
Qualitone
Ear, Nose, Throat · 120d
Cleared Aug 03, 1989
APACERAM OSSICULAR PROSTHESIS
K893134 · ETB
Asahi Optical Co. C/O Rosati...
Ear, Nose, Throat · 100d
Cleared Jul 14, 1989
ILO88 OTODYNAMIC ANALYZER SCREENING AUDIOMETER
K890124 · EWO
Grason-Stadler, Inc.
Ear, Nose, Throat · 184d
Cleared Jul 14, 1989
TRACOR RA500 AUDIOMETER
K891373 · EWO
Tracor Instruments Austin, Inc.
Ear, Nose, Throat · 127d
Cleared Jul 14, 1989
ITE PRESCRIPTION SERIES MODEL LP
K891915 · ESD
Us Hearing Centers, Inc.
Ear, Nose, Throat · 109d
Cleared Jul 14, 1989
ITE PRESCRIPTION SERIES MODEL PP + F
K891916 · ESD
Us Hearing Centers, Inc.
Ear, Nose, Throat · 109d
Cleared Jun 22, 1989
'EXMOOR' SINGLE USE SUCTION TUBE
K892504 · LRC
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 72d
Cleared Jun 22, 1989
PHONIC EAR ITE/ITC HRNG AID 901, 902, 903, 906,911
K892803 · ESD
United Hearing Systems, Inc.
Ear, Nose, Throat · 66d
Cleared Jun 21, 1989
HANDTYMP SCREENER MODEL 2000 + 2002 REMOTE TRANS.
K890864 · ETY
Rastronics USA, Inc.
Ear, Nose, Throat · 120d
Cleared Jun 21, 1989
CANNULATED BIOPSY FORCEPS
K892687 · EOQ
Zinnanti Surgical Instruments, Inc.
Ear, Nose, Throat · 69d
Cleared Jun 16, 1989
OSSICULAR PROSTHESIS: 8 PARTIAL, 3 TOTAL
K884884 · ETA
Porex Technologies Corp. of Georgia
Ear, Nose, Throat · 206d
Cleared Jun 16, 1989
ALPHA MODEL I ITE HEARING AID
K890271 · ESD
Alpha Instruments, Inc.
Ear, Nose, Throat · 149d
Cleared Jun 16, 1989
JESBERG ESOPHAGOSCOPE
K892259 · EOX
Zinnanti Surgical Instruments, Inc.
Ear, Nose, Throat · 73d
Cleared Jun 14, 1989
PERSONAL AMPLIFIER MODEL ULTRA HELIX
K893433 · ESD
Electone, Inc.
Ear, Nose, Throat · 43d
Cleared Jun 09, 1989
STORZ DX CENTER:IMPEDANCE TEST W/RHINO & AUDIO OPT
K883293 · ETY
Storz Instrument Co.
Ear, Nose, Throat · 309d
Cleared Jun 07, 1989
2400 AUDIOMETER, IMPEDANCE METER & HRNG. AID ANALY
K890842 · EWO
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 106d
Cleared Jun 06, 1989
MODEL 20-P EXTENDED HIGH FREQUENCY AUDIOMETER
K890497 · EWO
Monitor/Demlar
Ear, Nose, Throat · 125d
Cleared Jun 06, 1989
TELSTAR MODEL 1/3 ITE HEARING AID
K892457 · ESD
Telstar Electronics, Inc.
Ear, Nose, Throat · 57d