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
3217–3240 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Feb 07, 1983
AUDIT
K822335 · EWO
Axonics, Inc.
Ear, Nose, Throat · 187d
Cleared Feb 01, 1983
MODEL F1 HEARING AID
K823067 · ESD
Katz Hearing Aid Center
Ear, Nose, Throat · 105d
Cleared Feb 01, 1983
PHONIC EAR
K830098 · ESD
Phonic Ear, Inc.
Ear, Nose, Throat · 21d
Cleared Jan 28, 1983
EMERGENCY TRACHEOSTOMY INSTRUMENT SET
K822618 · LJW
Kelleher Corp.
Ear, Nose, Throat · 148d
Cleared Jan 28, 1983
COLLAR BUTTON VENT TUBE
K823907 · ETD
Treace Medical, Inc.
Ear, Nose, Throat · 31d
Cleared Jan 28, 1983
GROMMET VENT TUBE
K823908 · ETD
Treace Medical, Inc.
Ear, Nose, Throat · 31d
Cleared Jan 28, 1983
COLLAR BUTTON VENT TUBE
K830085 · ETD
Treace Medical, Inc.
Ear, Nose, Throat · 17d
Cleared Jan 21, 1983
RCI EARMATE
K823089 · ESD
Rci, Inc.
Ear, Nose, Throat · 94d
Cleared Jan 21, 1983
RIONET HEARING AID HB-32P
K823803 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 35d
Cleared Jan 21, 1983
RIONET HEARING AID HB-69CI
K823847 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 31d
Cleared Jan 21, 1983
EMERGENCY TRACHEOSTOMY KIT
K823872 · EWC
Omnicon Medical Corp.
Ear, Nose, Throat · 25d
Cleared Jan 21, 1983
KNIFE BLADE TIP
K823911 · JYO
Treace Medical, Inc.
Ear, Nose, Throat · 24d
Cleared Jan 21, 1983
MIRROR TIP
K823915 · KAI
Treace Medical, Inc.
Ear, Nose, Throat · 24d
Cleared Jan 21, 1983
WAX CURETTE TIP
K823916 · JYG
Treace Medical, Inc.
Ear, Nose, Throat · 24d
Cleared Jan 17, 1983
TECH. CLARATRON & INDUSTRIAL AMPLIFIER
K823244 · ESD
Longview Hearing Aid Center
Ear, Nose, Throat · 77d
Cleared Jan 17, 1983
WILSON EUSTACHIAN TUBAL, SONOGRAPH
K823774 · ETK
Antares Technical Associates, Inc.
Ear, Nose, Throat · 34d
Cleared Jan 07, 1983
101M IN-THE-EAR
K823073 · ESD
Danavox, Inc.
Ear, Nose, Throat · 80d
Cleared Jan 07, 1983
SAY
K823118 · ESE
Kells Medical, Inc.
Ear, Nose, Throat · 78d
Cleared Jan 07, 1983
TEL-STAR NU-WAY & GENERIC E
K823178 · ESD
Omni Hearing Systems
Ear, Nose, Throat · 73d
Cleared Jan 07, 1983
LOW PRESSURE BLOM-SINGER VOICE PROSTHES
K823749 · EWL
Bivona Medical Technologies
Ear, Nose, Throat · 25d
Cleared Jan 05, 1983
ACOH WELLNESS TESTER
K823554 · EWO
Occupational Health, Inc.
Ear, Nose, Throat · 35d
Cleared Dec 28, 1982
HEARING AID UNITRON #UE4-H
K823669 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 21d
Cleared Dec 15, 1982
BEHIND-THE-EAR HEARING AID #8003
K823531 · ESD
Danavox, Inc.
Ear, Nose, Throat · 16d
Cleared Dec 09, 1982
HEARING AID HB-33 RIONET
K823383 · ESD
Kindel & Anderson
Ear, Nose, Throat · 27d