Fujifilm Corporation
FDA 510(k) & PMA Approved Devices — 67 products
Total Devices67
Categories22
Latest FDA decision2026-08-12
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K261170 | BA-004CC | ITX | 2026-08-12 | View |
| 510(k) | K260567 | EW10-EC02 Endoscopy Support Program | QNP | 2026-08-07 | View |
| 510(k) | K261880 | FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01 | FET | 2026-07-02 | View |
| 510(k) | K253137 | FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T | EOQ | 2026-06-16 | View |
| 510(k) | K254075 | Synapse Lung Nodule AI | OEB | 2026-05-27 | View |
| 510(k) | K254189 | Synapse 3D Base Tools (V7.2) | QIH | 2026-04-30 | View |
| 510(k) | K253862 | APERTO Lucent MRI System | LNH | 2026-04-06 | View |
| 510(k) | K251861 | FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000 | FDT | 2026-03-09 | View |
| 510(k) | K250550 | FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit | FDS | 2026-02-17 | View |
| 510(k) | K253568 | Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR | FDS | 2026-02-06 | View |
| 510(k) | K250863 | FUJIFILM Ultrasonic Endoscope EB-710US | EOQ | 2025-12-12 | View |
| 510(k) | K251386 | ECHELON Synergy | LNH | 2025-09-17 | View |
| 510(k) | K244017 | FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000 | EOQ | 2025-06-13 | View |
| 510(k) | K243512 | FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP | FDS | 2025-06-10 | View |
| 510(k) | K243261 | FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L | FDF | 2025-05-23 | View |
| 510(k) | K243762 | Synapse 3D Base Tools (V7.0) | QIH | 2025-05-21 | View |
| 510(k) | K250370 | SCENARIA View Phase 5.0 | JAK | 2025-05-20 | View |
| 510(k) | K243260 | FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R | FET | 2025-04-11 | View |
| 510(k) | K243091 | Over-tube (TR-1108A) | FED | 2024-11-01 | View |
| 510(k) | K242779 | Hood (DH-083ST) | FDS | 2024-10-11 | View |
No matching devices.
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