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
1105–1128 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Feb 10, 1998
FM RECEIVER - AUDITORY TRAINER
K974287 · EPF
Phonic Ear, Inc.
Ear, Nose, Throat · 88d
Cleared Jan 27, 1998
ENDOLYMPHATIC SAC TO MASTOID T-SHUNT
K974224 · ESZ
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 78d
Cleared Jan 26, 1998
RINOFLOW MICRONIZED E.N.T. WASH SYSTEM
K973875 · KMA
Respironics, Inc.
Ear, Nose, Throat · 108d
Cleared Jan 23, 1998
EXMOOR TYMPANOCENTESIS KIT (TK/1)
K973587 · JZF
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 123d
Cleared Jan 22, 1998
SPORT/AUDX OAE TEST INSTRUMENT WITH BIO-LOGIC EAR PROBE
K974076 · EWO
Bio-Logic Systems Corp.
Ear, Nose, Throat · 85d
Cleared Jan 22, 1998
MILLS INCUS HA SLEEVE
K974365 · ETB
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 64d
Cleared Jan 20, 1998
ARGOSY PROGRAMMABLE ONQUE
K974242 · ESD
Argosy Electronics
Ear, Nose, Throat · 69d
Cleared Jan 20, 1998
DIGITAL TINNITUS MASKING SYSTEM
K974501 · KLW
Petroff Audio Technologies
Ear, Nose, Throat · 53d
Cleared Jan 12, 1998
SONIX HEARING AID FITTING AND PROGRAMMING SYSTEM
K973880 · ESD
Sonix Technologies, Inc.
Ear, Nose, Throat · 90d
Cleared Jan 12, 1998
ESSENTIAL SHAVER SYSTEM
K974232 · EQJ
Gyrus Ent LLC
Ear, Nose, Throat · 61d
Cleared Dec 15, 1997
OPUS 2 - CANAL SERIES (ITC)
K974069 · ESD
Bernafon-Maico, Inc.
Ear, Nose, Throat · 48d
Cleared Dec 15, 1997
OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC)
K974152 · ESD
Bernafon-Maico, Inc.
Ear, Nose, Throat · 41d
Cleared Dec 15, 1997
OPUS 2 - FULL CONCHA SERIES - ITE
K974211 · ESD
Bernafon-Maico, Inc.
Ear, Nose, Throat · 35d
Cleared Dec 12, 1997
SHAH PERMAVENT
K974007 · ETD
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 52d
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