Medical Device Manufacturer · US , Lexington , MA

Fujifilm Healthcare Americas Corporation - FDA 510(k) Cleared Devices

13 submissions · 13 cleared · Since 2023

Recent clearances: FUJIFILM Stiffening Wire Device (SW-2000), Synapse PACS (7.5), Double Balloon Endoscope EN-840T, Over-tube TS-1214C

13

Total

13

Cleared

0

Denied

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

1 devices

1-1 of 1

Cleared Feb 07, 2024

FUJIFILM Endoscope Model EB-710XT

Ear, Nose, Throat · 28d