FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Ear, Nose, Throat ×
3,823 results
841–864 of 3,823
Search insights Median review: 65d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Feb 10, 2005
EVIS EXERA BRONCHOVIDEOSCOPE, OLYMPUS XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2AC
K050220 · EOQ
Olympus Medical Systems Corporation
Ear, Nose, Throat · 10d
Cleared Feb 04, 2005
AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS
K043219 · EWO
Interacoustics AS
Ear, Nose, Throat · 74d
Cleared Jan 28, 2005
NEUROMONICS TINNITUS TREATMENT
K043274 · KLW
Neuromonics Pty, Ltd.
Ear, Nose, Throat · 63d
Cleared Jan 24, 2005
FISCH TITANIUM MIDDLE EAR PROSTHESES
K043375 · ETA
Karl Storz Endoscopy
Ear, Nose, Throat · 47d
Cleared Dec 23, 2004
EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS
K043090 · LZI
Phonic Ear, Inc.
Ear, Nose, Throat · 45d
Cleared Nov 22, 2004
PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134
K043138 · EWL
Atos Medical AB
Ear, Nose, Throat · 10d
Cleared Nov 08, 2004
OTOMIMIX
K042516 · NEA
Walter Lorenz Surgical, Inc.
Ear, Nose, Throat · 53d
Cleared Oct 01, 2004
KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MM
K042503 · ETA
Heinz Kurz GmbH Medizintechnik
Ear, Nose, Throat · 16d
Cleared Sep 10, 2004
CHIN-UP STRIP
K040491 · LWF
Dale Miller, Inc. - the Chin-Up Company
Ear, Nose, Throat · 197d
Cleared Sep 10, 2004
MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT
K041381 · LYA
Medtronic Xomed, Inc.
Ear, Nose, Throat · 108d
Cleared Sep 03, 2004
OTOGRAM
K041853 · ETW
Tympany, Inc.
Ear, Nose, Throat · 57d
Cleared Aug 26, 2004
BAHA DIVINO
K042017 · LXB
Entific Medical Systems, Inc.
Ear, Nose, Throat · 30d
Cleared Aug 20, 2004
RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION...
K040996 · NIX
Gyrus Ent LLC
Ear, Nose, Throat · 126d
Cleared Aug 12, 2004
XPS CURVED BUR
K041985 · EQJ
Medtronic Xomed, Inc.
Ear, Nose, Throat · 20d
Cleared Jul 23, 2004
XPS 3000 SYSTEM
K041523 · ERL
Medtronic Xomed, Inc.
Ear, Nose, Throat · 45d
Cleared Jul 12, 2004
XPS 3000 SYSTEM
K041413 · ERL
Medtronic Xomed, Inc.
Ear, Nose, Throat · 46d
Cleared Jul 01, 2004
REFUGE SOUND GENERATOR
K041302 · KLW
Micro-Ear Technology, Inc.
Ear, Nose, Throat · 48d
Cleared Jul 01, 2004
NASALCEASE
K041446 · EMX
Les Laboratorires Brothier, S.A.
Ear, Nose, Throat · 30d
Cleared Apr 30, 2004
SONA PILLOW
K040161 · MYB
Sleep Devices, Inc.
Ear, Nose, Throat · 98d
Cleared Apr 27, 2004
VISION SCIENCES MODEL ENT-2000V FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE
K040984 · EOB
Vision-Sciences, Inc.
Ear, Nose, Throat · 12d
Cleared Apr 19, 2004
BRONCHOVIDEOSCOPE OLYMPUS XBF-D160HM
K040940 · EOQ
Olympus Corporation
Ear, Nose, Throat · 7d
Cleared Apr 12, 2004
QUIESCENCE
K040330 · KLW
Spectral Visualization & Development,...
Ear, Nose, Throat · 61d
Cleared Apr 01, 2004
NUVASIVE NEUROVISION JJB SYSTEM
K040543 · ETN
Nuvasive, Inc.
Ear, Nose, Throat · 30d
Cleared Mar 31, 2004
OTOFLEX 100 TYE 1012
K033645 · ETY
Gn Otometrics A/S
Ear, Nose, Throat · 132d