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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Ear, Nose, Throat ×
3,798 results
2185–2208 of 3,798
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Jan 09, 1992
RIONET HEARING AID HB-52AS
K915319 · ESD
Rion Co. Ltd. Dba Rion Acoustic Device
Ear, Nose, Throat · 48d
Cleared Jan 09, 1992
SONOTONE BODY AID MODEL ST 1000 BODY WORN
K915517 · ESD
Sonotone Intl., Inc.
Ear, Nose, Throat · 59d
Cleared Jan 09, 1992
SONOTONE BEHIND THE EAR MODEL ST 49
K915518 · ESD
Sonotone Intl., Inc.
Ear, Nose, Throat · 59d
Cleared Jan 09, 1992
SONOTONE BEHIND THE EAR MODEL ST 53A
K915519 · ESD
Sonotone Intl., Inc.
Ear, Nose, Throat · 59d
Cleared Jan 09, 1992
REXTON RX12 WITH HORIZON PROGRAMMABLE OPTION
K915683 · ESD
Rexton, Inc.
Ear, Nose, Throat · 21d
Cleared Jan 09, 1992
REXTON RX34 WITH HORIZON PROGRAMMABLE OPTION
K915684 · ESD
Rexton, Inc.
Ear, Nose, Throat · 21d
Cleared Jan 03, 1992
GRIESHABER TWO FUNCTION MANIPULATOR
K914585 · EQH
Grieshaber & Co.
Ear, Nose, Throat · 79d
Cleared Jan 03, 1992
GRIESHABER THREE FUNCTION MANIPULATOR
K914586 · EQH
Grieshaber & Co.
Ear, Nose, Throat · 79d
Cleared Dec 30, 1991
PHONAK 9000-AF ITE HEARING INSTRUMENT SERIES
K915461 · ESD
Phonak, Inc.
Ear, Nose, Throat · 26d
Cleared Dec 27, 1991
TEF/PLATINUM PISTON
K915120 · ETB
River Medical, Inc.
Ear, Nose, Throat · 44d
Cleared Dec 23, 1991
TEF/WIRE PISTON
K915121 · ETB
River Medical, Inc.
Ear, Nose, Throat · 40d
Cleared Dec 18, 1991
PTFE PISTON
K913285 · ETB
River Medical, Inc.
Ear, Nose, Throat · 147d
Cleared Dec 18, 1991
H/A TOTAL-REGULAR, H/A TOTAL-OFFSET
K913286 · ETA
River Medical, Inc.
Ear, Nose, Throat · 147d
Cleared Dec 18, 1991
H/A PARTIAL - REGULAR & H/A PARTIAL - OFFSET
K913287 · ETB
River Medical, Inc.
Ear, Nose, Throat · 147d
Cleared Dec 18, 1991
ASPIRATING ENDO OCULAR PROBE
K914247 · EQH
Surgical Technologies, Inc.
Ear, Nose, Throat · 86d
Cleared Dec 10, 1991
WANG/MILL-ROSE TRANSBRONCHIAL ASPIRATION NEEDLE
K914181 · EOQ
Mill-Rose Laboratory
Ear, Nose, Throat · 83d
Cleared Dec 05, 1991
THE MONITOR/DEMLAR MODEL MI-5000 AUDIOMETER
K913356 · EWO
Monitor Instruments, Inc.
Ear, Nose, Throat · 128d
Cleared Dec 05, 1991
PHILIPS P74P BEHIND-THE-EAR HEARING AID
K915252 · ESD
Philips Hearing Instruments Co.
Ear, Nose, Throat · 17d
Cleared Dec 04, 1991
WEHRS INCUS AND INCUS-STAPES PROSTHESES
K910685 · ETB
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 288d
Cleared Nov 27, 1991
DRILL MODULES MODELS 2116/2117
K914346 · ERL
Micro Surgical Instruments Corp.
Ear, Nose, Throat · 61d
Cleared Nov 27, 1991
OTOSONIC (OSI) LPS IN-THE-EAR HEARING AID
K914981 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 21d
Cleared Nov 27, 1991
BELTONE PROFILE IN-THE-EAR HEARING AID
K914982 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 21d
Cleared Nov 22, 1991
OLYMPUS FLEXIBLE TIP THORACOSCOPE
K913829 · EWY
Olympus Corp.
Ear, Nose, Throat · 88d
Cleared Nov 22, 1991
OTOSONIC ACS-ASP
K914939 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 18d