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
1105–1128 of 3,798
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Dec 12, 1997
RESOUND STEALTH CIC
K974081 · ESD
Resound Corp.
Ear, Nose, Throat · 44d
Cleared Dec 12, 1997
HI-69E, HI-69N, HI-69P
K974129 · ESD
Rockwin Corp.
Ear, Nose, Throat · 39d
Cleared Dec 12, 1997
RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMMER)
K974257 · ESD
Resound Corp.
Ear, Nose, Throat · 29d
Cleared Dec 12, 1997
UNITRON MODEL F/X PROGRAMMABLE (MINI BTE)
K974338 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 24d
Cleared Dec 12, 1997
UNITRON MODEL SOUND F/XD PROGRAMMABLE
K974339 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 24d
Cleared Dec 12, 1997
UNITRON MODEL SOUND F/XP PROGRAMMABLE MINI BTE
K974340 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 24d
Cleared Dec 11, 1997
HYUNJAE CORPORATION - NUSIL EARMOLD IMPRESSION MATERIAL
K973927 · ESD
Hyunjae Corp.
Ear, Nose, Throat · 57d
Cleared Nov 25, 1997
ARTICULATE FITTING SYSTEM
K973320 · EWO
Decibel Instruments, Inc.
Ear, Nose, Throat · 83d
Cleared Nov 21, 1997
FLEXTIP GRASPER
K972450 · EOB
Endius, Inc.
Ear, Nose, Throat · 144d
Cleared Nov 21, 1997
K-PISTON WITH BAND HOOK /ANGULAR PISTON
K973356 · ETB
Heinz Kurz
Ear, Nose, Throat · 74d
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