Fujifilm Corporation - FDA 510(k) Cleared Devices
Recent clearances: Synapse Lung Nodule AI, Synapse 3D Base Tools (V7.2), APERTO Lucent MRI System
63
Total
63
Cleared
0
Denied
FDA 510(k) Regulatory Record - Fujifilm Corporation Gastroenterology & Urology ✕
37 devices
Cleared
Mar 09, 2026
FUJIFILM Endoscope Model ED-S100TP
Gastroenterology & Urology
265d
Cleared
Feb 17, 2026
FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit
Gastroenterology & Urology
357d
Cleared
Feb 06, 2026
Hood DH-084STR
Gastroenterology & Urology
81d
Cleared
Jun 10, 2025
FUJIFILM Endoscope Model EG-840N
Gastroenterology & Urology
210d
Cleared
May 23, 2025
FUJIFILM Endoscope Model EC-860P/M
Gastroenterology & Urology
220d
Cleared
Apr 11, 2025
FUJIFILM Processor EP-8000
Gastroenterology & Urology
178d
Cleared
Nov 01, 2024
Over-tube (TR-1108A)
Gastroenterology & Urology
32d
Cleared
Oct 11, 2024
Hood (DH-083ST)
Gastroenterology & Urology
28d
Cleared
Sep 04, 2024
FUJIFILM Endoscope Model EG-840N
Gastroenterology & Urology
230d
Cleared
Dec 15, 2023
EW10-EC02 Endoscopy Support Program
Gastroenterology & Urology
273d
Cleared
Sep 08, 2023
FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01
Gastroenterology & Urology
261d
Cleared
Aug 19, 2022
FUJIFILM Ultrasonic Endoscope EG-740UT
Gastroenterology & Urology
112d
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