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
1753–1776 of 3,798
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Aug 09, 1994
THE CANAL (C.I.C.) AKA/HIDDEN EAR
K941107 · ESD
Qualitone, Inc.
Ear, Nose, Throat · 155d
Cleared Aug 09, 1994
WATER IRRIGATOR, W1 200
K941325 · KHH
Strong Medical, Inc.
Ear, Nose, Throat · 144d
Cleared Aug 09, 1994
CRYSTAL EAR
K942189 · ESD
Crystal Care Intl., Inc.
Ear, Nose, Throat · 97d
Cleared Aug 09, 1994
PHILIPS M38 SERIES
K943395 · ESD
Philips Hearing Instruments Co.
Ear, Nose, Throat · 26d
Cleared Aug 04, 1994
EARCRAFT HEARING AID
K940670 · ESD
Earcraft, Inc.
Ear, Nose, Throat · 169d
Cleared Aug 02, 1994
FORCEPS, PUNCHES, SCISSORS
K943074 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 35d
Cleared Jul 29, 1994
BELTONE SERIES 100 AUDIOMETERS
K940216 · EWO
Beltone Electronics Corp.
Ear, Nose, Throat · 196d
Cleared Jul 29, 1994
AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS
K942158 · EPP
Wfr/Aquaplast Corp.
Ear, Nose, Throat · 87d
Cleared Jul 25, 1994
MIRACLE-EAR EAR IMPRESSION MATERIAL
K941859 · ESD
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 101d
Cleared Jul 20, 1994
STIMULATING SURGICAL INSTRUMENTS
K934733 · ETN
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 292d
Cleared Jul 20, 1994
GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHT
K941662 · EQH
Gm Engineering, Inc.
Ear, Nose, Throat · 106d
Cleared Jul 20, 1994
HAE 1
K942829 · ESD
Hearing Aid Express
Ear, Nose, Throat · 36d
Cleared Jul 20, 1994
HAE 3
K942830 · ESD
Hearing Aid Express
Ear, Nose, Throat · 36d
Cleared Jul 20, 1994
HAE 2
K942831 · ESD
Hearing Aid Express
Ear, Nose, Throat · 36d
Cleared Jul 20, 1994
AURIS CIC
K943144 · ESD
General Hearing Instruments, Inc.
Ear, Nose, Throat · 21d
Cleared Jul 18, 1994
XOMED-TREACE SCOPESHEATH
K933672 · EOB
Xomed-Treace, Inc.
Ear, Nose, Throat · 355d
Cleared Jul 18, 1994
RICHARD ROD LENS LARYNGOSCOPE
K941264 · EOQ
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 124d
Cleared Jul 18, 1994
HI-PRO/NOAH UNIVERSAL HEARING INSTRUMENT
K942749 · ESD
Madsen Electronics (Canada) , Ltd.
Ear, Nose, Throat · 38d
Cleared Jul 08, 1994
EXTERNAL NASAL SPLINT
K942724 · EPP
Micromed Development Corp.
Ear, Nose, Throat · 29d
Cleared Jul 07, 1994
DAIL A HEARING SCREENING TEST
K935719 · EWO
Occupational Hearing Services
Ear, Nose, Throat · 219d
Cleared Jul 06, 1994
MODEL#1550 MARSONA(R) TINNITUS MASKER
K940567 · KLW
Marpac, Inc.
Ear, Nose, Throat · 148d
Cleared Jul 05, 1994
STAR 42 PP SP STAR 42 DIGITALLY PROGRAMMABLE HEARING AID
K942594 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 34d
Cleared Jul 01, 1994
BIVONA NASAL TURBINATE STENT
K935053 · LYA
Bivona Medical Technologies
Ear, Nose, Throat · 253d
Cleared Jun 29, 1994
SUPER-SIL
K940164 · ESD
Finetone Hearing Instruments
Ear, Nose, Throat · 174d