Medical Device Manufacturer · JP , Ashigara Kami-Gun

Fujifilm Corporation - FDA 510(k) Cleared Devices

63 submissions · 63 cleared · Since 2018

Recent clearances: Synapse Lung Nodule AI, Synapse 3D Base Tools (V7.2), APERTO Lucent MRI System

63

Total

63

Cleared

0

Denied

FDA 510(k) Regulatory Record - Fujifilm Corporation Ear, Nose, Throat ✕

5 devices

1-5 of 5

Cleared Dec 12, 2025

FUJIFILM Ultrasonic Endoscope EB-710US

Ear, Nose, Throat · 266d

Cleared Jun 13, 2025

FUJIFILM Endoscope Model EB-710P

Ear, Nose, Throat · 168d

Cleared Aug 23, 2019

FUJIFILM Bronchoscope

Ear, Nose, Throat · 240d

Cleared Apr 04, 2019

FUJIFILM Video Bronchoscopes

Ear, Nose, Throat · 227d

Cleared Feb 22, 2019

FUJIFILM Ultrasonic Endoscope

Ear, Nose, Throat · 141d