Fujifilm Healthcare Americas Corporation - FDA 510(k) Cleared Devices
12
Total
12
Cleared
0
Denied
Fujifilm Healthcare Americas Corporation has 12 FDA 510(k) cleared medical devices. Based in Lexington, US.
Latest FDA clearance: Sep 2025. Active since 2023. Primary specialty: Radiology.
Browse the FDA 510(k) cleared devices submitted by Fujifilm Healthcare Americas Corporation Filter by specialty or product code using the sidebar.
FDA 510(k) cleared devices by Fujifilm Healthcare Americas Corporation
12 devices
Cleared
Sep 26, 2025
FUJIFILM Stiffening Wire Device (SW-2000)
Gastroenterology & Urology
161d
Cleared
Jun 30, 2025
Synapse PACS (7.5)
Radiology
216d
Cleared
Jun 13, 2024
Double Balloon Endoscope EN-840T, Over-tube TS-1214C
Gastroenterology & Urology
258d
Cleared
May 10, 2024
APERTO Lucent MRI System
Radiology
179d
Cleared
May 03, 2024
ECHELON Synergy V10.0
Radiology
168d
Cleared
Apr 26, 2024
FCT iSTREAM Phase 1
Radiology
171d
Cleared
Feb 07, 2024
FUJIFILM Endoscope Model EB-710XT
Ear, Nose, Throat
28d
Cleared
Dec 13, 2023
Endoscopic Ultrasonic Probe (P2612S-L)
Radiology
189d
Cleared
Nov 20, 2023
ARIETTA x10
Radiology
143d
Cleared
Oct 12, 2023
Scenaria View 4.2
Radiology
134d
Cleared
Sep 15, 2023
Over-tube (TR-1208A)
Gastroenterology & Urology
182d
Cleared
Sep 01, 2023
Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)
Gastroenterology & Urology
30d