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
913–936 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Apr 05, 2002
HISONIC-TRD TINNITUS RELIEF DEVICE
K013253 · KLW
Hearing Innovations, Inc.
Ear, Nose, Throat · 189d
Cleared Apr 05, 2002
MICROVASIVE ZERO TIP AIRWAY RETRIEVAL BASKET, MODELS M00513200 AND M00513210
K020765 · KTI
Boston Scientific Corp
Ear, Nose, Throat · 28d
Cleared Mar 13, 2002
MTP CLEARVISION DISPOSABLE TUBING SET
K020599 · EOB
Mtp Medical Technical Promotion GmbH
Ear, Nose, Throat · 19d
Cleared Mar 08, 2002
DIEGO POWERED DISSECTOR AND DRILL SYSTEM
K020594 · ERL
Gyrus Ent LLC
Ear, Nose, Throat · 14d
Cleared Mar 01, 2002
REPROCESSED DISPOSABLE TROCARS
K013987 · KBG
Adven Medical
Ear, Nose, Throat · 87d
Cleared Jan 22, 2002
STIMULUS - DISSECTION INSTRUMENTS
K014165 · ETN
Medtronic Xomed, Inc.
Ear, Nose, Throat · 34d
Cleared Jan 16, 2002
KSEA CLEARVISION LENS IRRIGATION SYSTEM
K013838 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 58d
Cleared Jan 09, 2002
COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0008021-1, 0008022-1
K013243 · KHJ
Bioform, Inc.
Ear, Nose, Throat · 103d
Cleared Dec 26, 2001
XENF-TP RHINO-LARYNGOFIBERSCOPE, ITS ACESSORIES AND ANCILLARY EQUIPMENT
K013591 · EOB
Olympus Optical Co., Ltd.
Ear, Nose, Throat · 57d
Cleared Nov 28, 2001
SILMED NASAL SEPTAL BUTTON
K013696 · LFB
Silmed, Inc.
Ear, Nose, Throat · 21d
Cleared Nov 27, 2001
GIMMI ALPHA SINUSCOPES MODEL # E.8282.01/31/71 + E.8284.01/31/71
K013731 · EOQ
Gimmi GmbH
Ear, Nose, Throat · 18d
Cleared Nov 09, 2001
CLIP PARTIAL PROSTHESIS-TITANIUM DRESDEN, MODEL 1002 250-257
K013573 · ETB
Heinz Kurz GmbH Medizintechnik
Ear, Nose, Throat · 11d
Cleared Oct 30, 2001
SEPRAGEL SINUS
K012532 · LYA
Genzyme Corp.
Ear, Nose, Throat · 85d
Cleared Oct 25, 2001
MACROPORE ENT RECONSTRUCTION FILM
K012769 · NHB
Macropore Biosurgery, Inc.
Ear, Nose, Throat · 69d
Cleared Oct 18, 2001
LORENZ LACTOSORB LARYNGOTRACHEAL RECONSTRUCTION IMPLANTS
K012409 · NHB
Walter Lorenz Surgical, Inc.
Ear, Nose, Throat · 80d
Cleared Sep 21, 2001
AUDIOSCAN VERIFIT, MODEL VF-1
K012306 · ETW
Etymonic Design, Inc.
Ear, Nose, Throat · 60d
Cleared Sep 21, 2001
SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT)
K012456 · ERL
Sodemsystems
Ear, Nose, Throat · 51d
Cleared Sep 13, 2001
OTO-CEM
K011338 · NEA
Ototech, Inc.
Ear, Nose, Throat · 134d
Cleared Aug 15, 2001
HADGEL, 4 GRAM/SYRINGE
K011544 · LYA
Seikagaku Corp.
Ear, Nose, Throat · 89d
Cleared Aug 10, 2001
OLYMPUS SPRAY CATHETER PW-6C-1
K012073 · EOQ
The Olympus Optical Co.
Ear, Nose, Throat · 39d
Cleared Jul 26, 2001
GSI AUDERA
K011135 · EWO
Nicolet Biomedical
Ear, Nose, Throat · 104d
Cleared Jul 25, 2001
XENF-DP RHINO-LARYNGOFIBERSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENT
K011869 · EOB
The Olympus Optical Co.
Ear, Nose, Throat · 41d
Cleared Jul 23, 2001
BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM.
K011438 · LXB
Entific Medical Systems, Inc.
Ear, Nose, Throat · 74d
Cleared Jul 18, 2001
VIVO 200 DPS VIVOSCAN
K003364 · EWO
Vivosonic, Inc.
Ear, Nose, Throat · 264d