Medical Device Manufacturer · US , Lexington , MA

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

12 submissions · 12 cleared · Since 2023
12
Total
12
Cleared
0
Denied

FDA 510(k) cleared devices by Fujifilm Healthcare Americas Corporation Gastroenterology & Urology ✕

4 devices
1-4 of 4
Cleared Sep 26, 2025
FUJIFILM Stiffening Wire Device (SW-2000)
K251204 · FDA
Gastroenterology & Urology · 161d
Cleared Jun 13, 2024
Double Balloon Endoscope EN-840T, Over-tube TS-1214C
K233321 · FDA
Gastroenterology & Urology · 258d
Cleared Sep 15, 2023
Over-tube (TR-1208A)
K230752 · FED
Gastroenterology & Urology · 182d
Cleared Sep 01, 2023
Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)
K232314 · FDS
Gastroenterology & Urology · 30d
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