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Fujifilm Corporation FDA Approvals
0 new drug approvals and 37 device clearances on file. Matched by name to FUJIY.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| SCENARIA View Phase 6.0510(k)Sep 18, 2026Radiology |
| APERTO Lucent MRI System510(k)Sep 16, 2026Radiology |
| FCT iStream Phase 2510(k)Sep 4, 2026Radiology |
| BA-004CC510(k)Aug 12, 2026Radiology |
| EW10-EC02 Endoscopy Support Program510(k)Aug 7, 2026Gastroenterology, Urology |
| FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01510(k)Jul 2, 2026Gastroenterology, Urology |
| FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T510(k)Jun 16, 2026Ear, Nose, Throat |
| Synapse Lung Nodule AI510(k)May 27, 2026Radiology |
| Synapse 3D Base Tools (V7.2)510(k)Apr 30, 2026Radiology |
| APERTO Lucent MRI System510(k)Apr 6, 2026Radiology |
| FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000510(k)Mar 9, 2026Gastroenterology, Urology |
| FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit510(k)Feb 17, 2026Gastroenterology, Urology |
| Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR510(k)Feb 6, 2026Gastroenterology, Urology |
| FUJIFILM Ultrasonic Endoscope EB-710US510(k)Dec 12, 2025Ear, Nose, Throat |
| ECHELON Synergy510(k)Sep 17, 2025Radiology |
| FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000510(k)Jun 13, 2025Ear, Nose, Throat |
| FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP510(k)Jun 10, 2025Gastroenterology, Urology |
| FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L510(k)May 23, 2025Gastroenterology, Urology |
| Synapse 3D Base Tools (V7.0)510(k)May 21, 2025Radiology |
| SCENARIA View Phase 5.0510(k)May 20, 2025Radiology |
| FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R510(k)Apr 11, 2025Gastroenterology, Urology |
| Over-tube (TR-1108A)510(k)Nov 1, 2024Gastroenterology, Urology |
| Hood (DH-083ST)510(k)Oct 11, 2024Gastroenterology, Urology |
| FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP510(k)Sep 4, 2024Gastroenterology, Urology |
| EW10-EC02 Endoscopy Support Program510(k)Dec 15, 2023Gastroenterology, Urology |
| FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01510(k)Sep 8, 2023Gastroenterology, Urology |
| Synapse 3D Base Tools v6.6510(k)Nov 10, 2022Radiology |
| FUJIFILM Ultrasonic Endoscope EG-740UT510(k)Aug 19, 2022Gastroenterology, Urology |
| Endoscope Model EG-580UT and Endoscope Model EG-580UR510(k)Aug 4, 2022Gastroenterology, Urology |
| FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2510(k)Jun 3, 2022Gastroenterology, Urology |
| Aspire Cristalle510(k)May 27, 2022Radiology |
| Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI510(k)Feb 4, 2022Gastroenterology, Urology |
| FDR Cross (DR-XD 3000)510(k)Nov 8, 2021Radiology |
| Balloon BS-3510(k)Oct 29, 2021Gastroenterology, Urology |
| Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2510(k)Aug 19, 2021Gastroenterology, Urology |
| Endoscope Model EI-740D/S510(k)Apr 9, 2021Gastroenterology, Urology |
| Synapse 3D, Synapse 3D Base Tools v6.1510(k)Feb 9, 2021Radiology |