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
289–312 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Feb 21, 2020
TGS Guidewire and updated Scopis Software
K193118 · PGW
Stryker Ent
Ear, Nose, Throat · 101d
Cleared Feb 20, 2020
Tinnitus Sound Generator Module
K193303 · KLW
GN Hearing A/S
Ear, Nose, Throat · 83d
Cleared Feb 14, 2020
TGS Universal Headrest with Mounting Arm
K193502 · PGW
Stryker Ent
Ear, Nose, Throat · 58d
Cleared Feb 13, 2020
Vathin Video Bronchoscope System
K191828 · EOQ
Hunan Vathin Medical Instrument Co.,...
Ear, Nose, Throat · 220d
Cleared Jan 30, 2020
TruDi Navigation System
K192397 · PGW
Biosense Webster
Ear, Nose, Throat · 149d
Cleared Jan 27, 2020
CMOS Video Rhino-Laryngoscope SSU
K192090 · EOB
Karl Storz SE & CO. KG
Ear, Nose, Throat · 175d
Cleared Jan 24, 2020
CMOS Video Esophagoscope SSU
K192523 · EOX
Karl Storz SE & CO. KG
Ear, Nose, Throat · 133d
Cleared Jan 16, 2020
GlideScope BFlex 3.8 Single-Use Bronchoscope
K193488 · EOQ
Verathon Medical (Canada) Ulc
Ear, Nose, Throat · 30d
Cleared Jan 03, 2020
Dillard Nasal Balloon Catheter
K181546 · LRC
Intuit Medical Products, LLC
Ear, Nose, Throat · 570d
Cleared Dec 20, 2019
RHIN1 Stylus
K192471 · GEI
Aerin Medical, Inc.
Ear, Nose, Throat · 101d
Cleared Dec 13, 2019
EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor...
K190715 · ERL
Interscope, Inc.
Ear, Nose, Throat · 269d
Cleared Dec 05, 2019
TOMi Scope
K191804 · QJG
Photonicare, Inc.
Ear, Nose, Throat · 153d
Cleared Nov 29, 2019
I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System,...
K192186 · GWN
Neurolign USA, LLC
Ear, Nose, Throat · 109d
Cleared Nov 26, 2019
Ion Endoluminal System
K192367 · EOQ
Intuitive Surgical, Inc.
Ear, Nose, Throat · 88d
Cleared Nov 15, 2019
Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting...
K191921 · PFO
Cochlear Americas
Ear, Nose, Throat · 120d
Cleared Nov 10, 2019
LATERA Absorbable Nasal Implant System
K192661 · NHB
Entellus Medical, Inc. (Aka Stryker Ent)
Ear, Nose, Throat · 46d
Cleared Oct 22, 2019
ClearEdge Balance System
K183661 · LXV
Quadrant Biosciences
Ear, Nose, Throat · 299d
Cleared Sep 18, 2019
BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602...
K191457 · PFO
Med-El Elektromedizinische Geraete GmbH
Ear, Nose, Throat · 110d
Cleared Sep 06, 2019
Rhino-Laryngo Videoscope Olympus ENF-VT3
K183416 · EOB
Olympus Medical Systems Corp.
Ear, Nose, Throat · 270d
Cleared Sep 06, 2019
PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U
K183516 · EOQ
Pentax of America, Inc.
Ear, Nose, Throat · 262d
Cleared Sep 06, 2019
EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F
K183525 · PSV
Olympus Medical Systems Corp.
Ear, Nose, Throat · 261d
Cleared Sep 06, 2019
Precision S 4K Sinuscope
K191102 · EOB
Stryker
Ear, Nose, Throat · 134d
Cleared Sep 05, 2019
EVIS EXERA III Bronchovideoscope Olympus BF-XT190
K183419 · EOQ
Olympus Medical Systems Corp.
Ear, Nose, Throat · 269d
Cleared Aug 30, 2019
Sutter RaVoR Bipolar Electrodes
K191732 · GEI
Sutter Medizintechnik GmbH
Ear, Nose, Throat · 63d