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
1129–1152 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Nov 19, 1997
FUTURA 67M, 68M, MEGAPOWERMP97, INTEGRA 70,71,72,73, SUPRA 51,52, SUPRA...
K973861 · ESD
Magnatone Hearing Aid Corp.
Ear, Nose, Throat · 41d
Cleared Nov 18, 1997
INTUBATION ENDOSCOPE AND INTRODUCER SHEATH
K970107 · EOQ
Urohealth Systems, Inc.
Ear, Nose, Throat · 309d
Cleared Nov 18, 1997
ULTRACELL PACKING WITH SLEEVE
K973085 · EMX
Ultracell Medical Technologies, Inc.
Ear, Nose, Throat · 92d
Cleared Nov 18, 1997
DISPOSABLE SILICONE EPISTAXIS CATHETER
K973656 · EMX
Specialty Surgical Products, Inc.
Ear, Nose, Throat · 54d
Cleared Nov 06, 1997
INVOTEC EAR TAMPON (WICK) W/STRING
K973578 · KCN
Invotec International, Inc.
Ear, Nose, Throat · 48d
Cleared Nov 05, 1997
POWERTREK INSTRUMENTS
K972057 · ERL
Medtrek Corp.
Ear, Nose, Throat · 156d
Cleared Nov 04, 1997
TUBINGEN TYMPANIC VENTILATION TUBE, TYMPANIC VENTILATION TUBES WITH ENE/S,...
K973226 · ETD
Heinz Kurz GmbH Medizintechnik
Ear, Nose, Throat · 69d
Cleared Nov 04, 1997
MAGNATONE / STERLING/ ST
K973665 · ESD
Magnatone Hearing Aid Corp.
Ear, Nose, Throat · 40d
Cleared Nov 04, 1997
OTICON DIGISOUND ITE
K973885 · ESD
Oticon, Inc.
Ear, Nose, Throat · 21d
Cleared Nov 04, 1997
OTICON DIGISOUND COMPACT
K973886 · ESD
Oticon, Inc.
Ear, Nose, Throat · 21d
Cleared Nov 04, 1997
PERFECT EAR/ MINI-CANAL/ PE-M, PE-ML, PE-MD), PERFECT EAR/ C.I.C./ (PEC,...
K973972 · ESD
Perfect Ear
Ear, Nose, Throat · 15d
Cleared Oct 31, 1997
GREATBATCH SCIENTIFIC MR COMPATIBLE SINUSCOPE
K971375 · EOB
Wilson Greatbatch Technologies, Inc.
Ear, Nose, Throat · 200d
Cleared Oct 31, 1997
AMPLAID 171S
K972862 · EWO
Amplifon S.P.A.
Ear, Nose, Throat · 88d
Cleared Oct 29, 1997
AIR CONDUCTION HEARING AID
K973846 · ESD
Baron Trading, Inc.
Ear, Nose, Throat · 21d
Cleared Oct 28, 1997
AM SERIES HEARING AID
K973579 · ESD
A & M Hearing, Ltd.
Ear, Nose, Throat · 39d
Cleared Oct 28, 1997
DUALINE 100 BTE
K973948 · ESD
Bernafon-Maico, Inc.
Ear, Nose, Throat · 12d
Cleared Oct 27, 1997
URO MED NERVE STIMULATOR
K970971 · ETN
Uromed Corp.
Ear, Nose, Throat · 224d
Cleared Oct 27, 1997
SUPER SILIPLUGS EAR PLUGS
K972923 · EWD
Interview Medical Technology Corp.
Ear, Nose, Throat · 80d
Cleared Oct 27, 1997
MODEL C-1 HEARING AID
K973043 · ESD
Better Hearing, Inc.
Ear, Nose, Throat · 73d
Cleared Oct 17, 1997
D72 DIGITAL
K972818 · ESD
Philips Hearing Instruments Co.
Ear, Nose, Throat · 80d
Cleared Oct 14, 1997
LORI/LORI, LORI-S (LORI STOCK AID)
K973376 · ESD
Lori Medical Laboratories, Inc.
Ear, Nose, Throat · 36d
Cleared Oct 08, 1997
PARTIAL/TOTAL/POROUS POLYETHYLENE OSSICULAR REPLACEMENT
K972815 · ETB
Grace Medical, Inc.
Ear, Nose, Throat · 72d
Cleared Oct 08, 1997
VYKER SILICONE EPISTAXIS CATHETER V-27030, VYKER SILICONE EPISTAXIS CATHETER...
K972922 · EMX
Interview Medical Technology Corp.
Ear, Nose, Throat · 61d
Cleared Oct 01, 1997
STRYKER HUMMER II MICRODEBRIDER SYSTEM
K972584 · ERL
Stryker Endoscopy
Ear, Nose, Throat · 83d