Medical Device Manufacturer · JP , Ashigara Kami-Gun

Fujifilm Corporation - FDA 510(k) Cleared Devices

65 submissions · 65 cleared · Since 2018

Recent clearances: FUJIFILM Processor EP-8000, FUJIFILM Endoscope Model EB-840S, Synapse Lung Nodule AI

65

Total

65

Cleared

0

Denied

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

6 devices

1-6 of 6

Cleared Jun 16, 2026

FUJIFILM Endoscope Model EB-840S

Ear, Nose, Throat · 264d

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