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

Total

Cleared

Denied

Fujifilm Healthcare Americas Corporation has 13 FDA 510(k) cleared medical devices. Based in Lexington, US.

Latest FDA clearance: Jun 2026. 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.

Fujifilm Healthcare Americas Corporation is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Fujifilm Healthcare Americas Corporation

13 devices

1-13 of 13

FUJIFILM Stiffening Wire Device (SW-2000)

K251204 · FDA

Gastroenterology & Urology · 161d

Double Balloon Endoscope EN-840T, Over-tube TS-1214C

K233321 · FDA

Gastroenterology & Urology · 258d

Cleared May 10, 2024

APERTO Lucent MRI System

K233629 · LNH

Radiology · 179d

Cleared May 03, 2024

ECHELON Synergy V10.0

FUJIFILM Endoscope Model EB-710XT

K240075 · EOQ

Ear, Nose, Throat · 28d

Cleared Dec 13, 2023

Endoscopic Ultrasonic Probe (P2612S-L)

Gastroenterology & Urology · 182d

Cleared Sep 01, 2023

Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)

K232314 · FDS

Gastroenterology & Urology · 30d

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

FDA 510(k) Regulatory Record - Fujifilm Healthcare Americas Corporation

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