Medical Device Manufacturer · JP , Ashigara Kami-Gun

Fujifilm Corporation - FDA 510(k) Cleared Devices

71 submissions · 71 cleared · Since 2018
View 71 510(k) Devices ↓
71
Total
71
Cleared
0
Denied
71 devices
26-50 of 71
Cleared Dec 15, 2023
EW10-EC02 Endoscopy Support Program
K230751 · QNP
Gastroenterology & Urology · 273d
Cleared Sep 08, 2023
FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01
K223827 · FDF
Gastroenterology & Urology · 261d
Cleared Nov 10, 2022
Synapse 3D Base Tools v6.6
K221677 · LLZ
Radiology · 154d
Cleared Aug 19, 2022
FUJIFILM Ultrasonic Endoscope EG-740UT
K221238 · ODG
Gastroenterology & Urology · 112d
Cleared Aug 04, 2022
Endoscope Model EG-580UT and Endoscope Model EG-580UR
K221952 · ODG
Gastroenterology & Urology · 30d
Cleared Jun 03, 2022
FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2
K214089 · ODG
Radiology · 157d
Cleared May 27, 2022
Aspire Cristalle
K212873 · MUE
Radiology · 260d
Cleared Feb 04, 2022
Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI
K220053 · KGE
Gastroenterology & Urology · 29d
Cleared Nov 08, 2021
FDR Cross (DR-XD 3000)
K212956 · OWB
Radiology · 53d
Cleared Oct 29, 2021
Balloon BS-3
K213195 · FDA
Gastroenterology & Urology · 30d
Cleared Aug 19, 2021
Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2
K212296 · FDS
Gastroenterology & Urology · 28d
Cleared Apr 09, 2021
Endoscope Model EI-740D/S
K210162 · FDS
Gastroenterology & Urology · 78d
Cleared Feb 09, 2021
Synapse 3D, Synapse 3D Base Tools v6.1
K203103 · LLZ
Radiology · 118d
Cleared Oct 30, 2020
FUJIFILM Distal End Cap
K203028 · FDT
Gastroenterology & Urology · 28d
Cleared Aug 20, 2020
FUJIFILM Video Laparoscope
K202130 · GCJ
General & Plastic Surgery · 20d
Cleared Jul 06, 2020
Fujifilm Ultrasonic Processor
K200850 · FDS
Gastroenterology & Urology · 97d
Cleared May 01, 2020
FUJIFILM EP-6000 Video Processor
K192286 · FET
Gastroenterology & Urology · 253d
Cleared Apr 10, 2020
DR-ID 1200SDK System
K200668 · MQB
Radiology · 28d
Cleared Feb 20, 2020
Video Laparoscope, Video Processor, Light Source
K192918 · GCJ
General & Plastic Surgery · 128d
Cleared Dec 11, 2019
FUJIFILM Distal Cap Models 33-40
K193123 · FDS
Gastroenterology & Urology · 29d
Cleared Nov 20, 2019
FUJIFILM Endoscope Model EC-760Z-V/L
K192664 · FDF
Gastroenterology & Urology · 56d
Cleared Nov 12, 2019
FDR D-EVO III flat panel detector system
K192932 · MQB
Radiology · 26d
Cleared Nov 01, 2019
FDR SE Lite
K192440 · MQB
Radiology · 56d
Cleared Oct 18, 2019
Synapse 3D Blood Flow Analysis
K191544 · LLZ
Radiology · 129d
Cleared Sep 27, 2019
FUJIFILM Duodenoscope Model ED-580XT
K191747 · FDT
Gastroenterology & Urology · 88d
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