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
313–336 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Aug 23, 2019
FUJIFILM Bronchoscope
K183607 · EOQ
Fujifilm Corporation
Ear, Nose, Throat · 240d
Cleared Aug 21, 2019
GlideScope BFlex 5.8 Single-Use Bronchoscope
K191948 · EOQ
Verathon Medical (Canada) Ulc
Ear, Nose, Throat · 30d
Cleared Aug 16, 2019
EQ Balance
K190735 · LXV
Upright Science, Inc.
Ear, Nose, Throat · 148d
Cleared Jul 15, 2019
Lyra
K191372 · EWO
Interacoustics A/S
Ear, Nose, Throat · 54d
Cleared Jul 12, 2019
Ambu aScope 4 RhinoLaryngo Intervention
K190972 · EOB
Ambu A/S
Ear, Nose, Throat · 88d
Cleared Jul 03, 2019
Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia...
K190589 · PFO
Cochlear Americas
Ear, Nose, Throat · 118d
Cleared Jun 12, 2019
PENTAX Medical ENT Video Imaging System
K183691 · EOB
Pentax of America, Inc.
Ear, Nose, Throat · 163d
Cleared May 23, 2019
PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and...
K183654 · EOQ
Pentax of America, Inc.
Ear, Nose, Throat · 147d
Cleared May 22, 2019
Ambu aScope 4 RhinoLaryngo Slim
K191080 · EOB
Ambu A/S
Ear, Nose, Throat · 28d
Cleared May 03, 2019
RELIEVA ULTIRRA Sinus Balloon Catheter
K190525 · LRC
Acclarent, Inc.
Ear, Nose, Throat · 60d
Cleared May 03, 2019
TruDi NAV Wire
K190532 · PGW
Acclarent, Inc.
Ear, Nose, Throat · 60d
Cleared May 02, 2019
Ponto 4
K190540 · LXB
Oticon Medical AB
Ear, Nose, Throat · 59d
Cleared Apr 19, 2019
Relieva Tract Balloon Dilation System
K183090 · QGK
Acclarent, Inc.
Ear, Nose, Throat · 164d
Cleared Apr 12, 2019
PuraSinus
K183015 · NHB
3-D Matrix, Inc.
Ear, Nose, Throat · 163d
Cleared Apr 04, 2019
FUJIFILM Video Bronchoscopes
K182253 · EOQ
Fujifilm Corporation
Ear, Nose, Throat · 227d
Cleared Mar 22, 2019
CMOS Video-Rhino-Laryngoscope System
K182186 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 221d
Cleared Mar 14, 2019
da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories
K182371 · NAY
Intuitive Surgical, Inc.
Ear, Nose, Throat · 195d
Cleared Mar 07, 2019
Bonebridge
K183373 · PFO
Med-El Elektromedizinische Geraete GmbH
Ear, Nose, Throat · 91d
Cleared Mar 06, 2019
Hearing Healthcare Pro
K183201 · ETY
Db Diagnostic Systems, Inc.
Ear, Nose, Throat · 107d
Cleared Feb 22, 2019
FUJIFILM Ultrasonic Endoscope
K182825 · EOQ
Fujifilm Corporation
Ear, Nose, Throat · 141d
Cleared Feb 14, 2019
Ion Endoluminal System
K182188 · EOQ
Intuitive Surgical
Ear, Nose, Throat · 185d
Cleared Feb 06, 2019
RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2, RHINO-LARYNGO VIDEOSCOPE OLYMPUS...
K182102 · EOB
Olympus Medical Systems Corp.
Ear, Nose, Throat · 187d
Cleared Jan 25, 2019
Earlens Contact Hearing Aid
K182480 · PLK
Earlens Corporation
Ear, Nose, Throat · 137d
Cleared Jan 09, 2019
PENTAX Medical EPK-3000 Video Imaging System
K182846 · EOB
Pentax of America, Inc.
Ear, Nose, Throat · 92d