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
265–288 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Oct 09, 2020
BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4...
K201983 · PFO
Med-El Elektromedizinische Geraete GmbH
Ear, Nose, Throat · 84d
Cleared Oct 09, 2020
Instrument Clamps Electromagnetic
K202609 · PGW
Stryker Corporation
Ear, Nose, Throat · 30d
Cleared Aug 27, 2020
Next Generation Balloon Dilation System
K201115 · LRC
Acclarent, Inc.
Ear, Nose, Throat · 122d
Cleared Aug 26, 2020
VenSure Balloon Device, VenSure Nav Balloon Device
K201472 · LRC
Fiagon GmbH
Ear, Nose, Throat · 84d
Cleared Aug 12, 2020
Orion
K200529 · LXV
Interacoustics A/S
Ear, Nose, Throat · 163d
Cleared Aug 12, 2020
VisualEyes
K200534 · GWN
Interacoustics A/S
Ear, Nose, Throat · 163d
Cleared Aug 12, 2020
TruDi Curette
K201174 · PGW
Acclarent, Inc.
Ear, Nose, Throat · 103d
Cleared Aug 11, 2020
HD Video Rhino Laryngoscope
K200740 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 141d
Cleared Jul 30, 2020
PENTAX Medical Video Bronchoscope EB-J10 Series
K200678 · EOQ
Pentax of America, Inc.
Ear, Nose, Throat · 136d
Cleared Jul 29, 2020
BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote
K200504 · PFO
Med-El Elektromedizinische Geraete GmbH
Ear, Nose, Throat · 149d
Cleared Jun 26, 2020
StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)
K200723 · PGW
Medtronic Navigation, Inc.
Ear, Nose, Throat · 99d
Cleared Jun 26, 2020
Ion Endoluminal System
K201146 · EOQ
Intuitive Surgical, Inc.
Ear, Nose, Throat · 58d
Cleared Jun 19, 2020
Multiflex Tinnitus Technology
K201370 · KLW
Starkey Laboratories, Inc.
Ear, Nose, Throat · 28d
Cleared Jun 05, 2020
Hummingbird Tympanostomy Tube System
K200952 · ETD
Preceptis Medical, Inc.
Ear, Nose, Throat · 57d
Cleared Jun 02, 2020
StarPore
K200532 · JOF
Anatomics Pty, Ltd.
Ear, Nose, Throat · 92d
Cleared May 27, 2020
TRV
K192652 · LXV
Interacoustics A/S
Ear, Nose, Throat · 246d
Cleared May 11, 2020
Thunderbeat Open Fine Jaw Type X Hand Instrument
K192103 · GEI
Olympus Medical Systems Corp.
Ear, Nose, Throat · 280d
Cleared Apr 24, 2020
Single Use Biopsy Forceps FB-456D
K200397 · EOQ
Olympus Medical Systems Corp.
Ear, Nose, Throat · 66d
Cleared Apr 15, 2020
Monarch Platform
K193534 · EOQ
Auris Health, Inc.
Ear, Nose, Throat · 117d
Cleared Apr 13, 2020
VivAer Stylus
K200300 · GEI
Aerin Medical, Inc.
Ear, Nose, Throat · 67d
Cleared Mar 23, 2020
TruDi Probe
K193453 · PGW
Acclarent, Inc.
Ear, Nose, Throat · 101d
Cleared Mar 10, 2020
FlexPointer 1.5 Single Use, FlexTube 3 Single Use
K200041 · PGW
Fiagon GmbH
Ear, Nose, Throat · 62d
Cleared Mar 02, 2020
BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider
K193356 · GEI
Covidien, LLC
Ear, Nose, Throat · 89d
Cleared Feb 27, 2020
Colibri Endoscopy System
K192305 · EOB
3nt Medical , Ltd.
Ear, Nose, Throat · 188d