Fujifilm Corporation - FDA 510(k) Cleared Devices
63
Total
63
Cleared
0
Denied
63 devices
Cleared
Nov 08, 2021
FDR Cross (DR-XD 3000)
Radiology
53d
Cleared
Oct 29, 2021
Balloon BS-3
Gastroenterology & Urology
30d
Cleared
Aug 19, 2021
Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2
Gastroenterology & Urology
28d
Cleared
Apr 09, 2021
Endoscope Model EI-740D/S
Gastroenterology & Urology
78d
Cleared
Feb 09, 2021
Synapse 3D, Synapse 3D Base Tools v6.1
Radiology
118d
Cleared
Oct 30, 2020
FUJIFILM Distal End Cap
Gastroenterology & Urology
28d
Cleared
Aug 20, 2020
FUJIFILM Video Laparoscope
General & Plastic Surgery
20d
Cleared
Jul 06, 2020
Fujifilm Ultrasonic Processor
Gastroenterology & Urology
97d
Cleared
May 01, 2020
FUJIFILM EP-6000 Video Processor
Gastroenterology & Urology
253d
Cleared
Apr 10, 2020
DR-ID 1200SDK System
Radiology
28d
Cleared
Feb 20, 2020
Video Laparoscope, Video Processor, Light Source
General & Plastic Surgery
128d
Cleared
Dec 11, 2019
FUJIFILM Distal Cap Models 33-40
Gastroenterology & Urology
29d
Cleared
Nov 20, 2019
FUJIFILM Endoscope Model EC-760Z-V/L
Gastroenterology & Urology
56d
Cleared
Nov 12, 2019
FDR D-EVO III flat panel detector system
Radiology
26d
Cleared
Nov 01, 2019
FDR SE Lite
Radiology
56d
Cleared
Oct 18, 2019
Synapse 3D Blood Flow Analysis
Radiology
129d
Cleared
Sep 27, 2019
FUJIFILM Duodenoscope Model ED-580XT
Gastroenterology & Urology
88d
Cleared
Sep 05, 2019
FUJIFILM Ultrasonic Endoscope
Gastroenterology & Urology
268d
Cleared
Aug 23, 2019
FUJIFILM Bronchoscope
Ear, Nose, Throat
240d
Cleared
Jul 16, 2019
FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L
Gastroenterology & Urology
207d
Cleared
Jul 03, 2019
Biopsy Positioner
Radiology
28d
Cleared
Jun 24, 2019
FUJIFILM Double Balloon Endoscope EI580BT
Gastroenterology & Urology
235d
Cleared
May 07, 2019
FUJIFILM Endoscope Model EC-760S-V/L
Gastroenterology & Urology
55d
Cleared
Apr 25, 2019
Synapse Enterprise Viewer Version 1.0
Radiology
155d
Cleared
Apr 04, 2019
FUJIFILM Video Bronchoscopes
Ear, Nose, Throat
227d