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
985–1008 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Mar 14, 2000
INTERACOUSTICS AT235 IMPEDANCE AUDIOMETER
K994254 · ETY
International Distributors of...
Ear, Nose, Throat · 88d
Cleared Mar 13, 2000
HYLASINE
K993362 · EMX
Biomatrix, Inc.
Ear, Nose, Throat · 159d
Cleared Mar 01, 2000
VOCOM IMPLANT- 8MM
K000533 · MIX
Smith & Nephew, Inc.
Ear, Nose, Throat · 13d
Cleared Feb 24, 2000
HORTMANN ECHOMASTER OAE ANALYZER
K994033 · EWO
Hortmann AG
Ear, Nose, Throat · 90d
Cleared Feb 11, 2000
AUDIOSCREENER OAE
K000184 · EWO
Kedly, Inc.
Ear, Nose, Throat · 22d
Cleared Feb 11, 2000
CAP PORP, CAP TORP
K000256 · ETB
Gyrus Ent LLC
Ear, Nose, Throat · 14d
Cleared Jan 28, 2000
COAGULATION ELECTRODE, MODEL 2000
K993900 · EOQ
Broncus Technologies, Inc.
Ear, Nose, Throat · 73d
Cleared Dec 28, 1999
PASCAL MEDICAL AB MENIETT 20
K991562 · ETY
Pascal Medical AB
Ear, Nose, Throat · 238d
Cleared Nov 24, 1999
BRANEMARK BONE-ANCHORED HEARING AID (BAHA) CORDELLE II
K992872 · LXB
Entific Medical Systems, Inc.
Ear, Nose, Throat · 90d
Cleared Nov 23, 1999
EASY-JET DEVICE
K972383 · KLZ
A.Stein - Regulatory Affairs Consulting
Ear, Nose, Throat · 880d
Cleared Nov 23, 1999
TURBO 7000 SHAVER AND DRILL CONSOLE
K992994 · ERL
Gyrus Ent LLC
Ear, Nose, Throat · 77d
Cleared Nov 10, 1999
MICROMEDICS S&T PARTIAL OSSICULAR REPLACEMENT PROSTHESIS
K993234 · ETB
Micromedics, Inc.
Ear, Nose, Throat · 44d
Cleared Nov 10, 1999
ZURICH TITANIUM OSSICULAR REPLACEMENT SYSTEM
K993583 · ETA
Stryker Corp.
Ear, Nose, Throat · 19d
Cleared Oct 07, 1999
XOMED BALL-TIP MONOPOLAR STIMULATOR PROBE
K992869 · ETN
Xomed, Inc.
Ear, Nose, Throat · 43d
Cleared Sep 24, 1999
FLEXIBLE NASOPHARYNGO-LARYNGOSCOPES, FLEXIBLE BRONCHOSCOPE
K992526 · EOB
Richard Wolf Medical Instruments Corp.
Ear, Nose, Throat · 58d
Cleared Sep 20, 1999
AMPLAID A724 AND A728
K992370 · ETY
Amplifon S.P.A.
Ear, Nose, Throat · 67d
Cleared Sep 16, 1999
SOCKET STAPES PISTON W/O LOOP, SCHOBEL, SCHOBEL-CAUSSE
K992839 · ETB
Heinz Kurz GmbH Medizintechnik
Ear, Nose, Throat · 24d
Cleared Sep 14, 1999
HYDROFERA BACTERISTATIC NASAL DRESSING
K983276 · EMX
Hydrofera, LLC
Ear, Nose, Throat · 362d
Cleared Aug 26, 1999
SILVERSTEIN MICROWICK
K991670 · ETD
Micromedics, Inc.
Ear, Nose, Throat · 101d
Cleared Aug 26, 1999
FLUOROPLASTIC VENTILATION TUBES
K992222 · ETD
Gyrus Ent LLC
Ear, Nose, Throat · 56d
Cleared Aug 09, 1999
MICROMEDICS S&T TOTAL OSSICULAR REPLACEMENT PROSTHESIS AND ACCESSORIES
K992138 · ETA
Micromedics, Inc.
Ear, Nose, Throat · 46d
Cleared Jul 13, 1999
NASO-LARYNGO-PHARYNGOSCOPE
K991560 · EOB
Fiber Imaging Technologies, Inc.
Ear, Nose, Throat · 70d
Cleared Jun 28, 1999
BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE
K984162 · MAH
Nobelpharma USA, Inc.
Ear, Nose, Throat · 221d
Cleared Jun 25, 1999
BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS
K991587 · EWL
Helix Medical, Inc.
Ear, Nose, Throat · 49d