Fujifilm Corporation
Fujifilm Corporation appears in FDA public data with 0 recalls, 70 510(k) clearances, 5 FDA inspections, and 1 compliance action on record. Its most recent 510(k) clearance was granted on September 18, 2026.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 70
- Inspections
- 5
- Compliance Actions
- 1
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K261229 | SCENARIA View Phase 6.0 | September 18, 2026 |
| K261283 | APERTO Lucent MRI System | September 16, 2026 |
| K253836 | FCT iStream Phase 2 | September 4, 2026 |
| K261170 | BA-004CC | August 12, 2026 |
| K260567 | EW10-EC02 Endoscopy Support Program | August 7, 2026 |
| K261880 | FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01 | July 2, 2026 |
| K253137 | FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T | June 16, 2026 |
| K254075 | Synapse Lung Nodule AI | May 27, 2026 |
| K254189 | Synapse 3D Base Tools (V7.2) | April 30, 2026 |
| K253862 | APERTO Lucent MRI System | April 6, 2026 |
| K251861 | FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS- | March 9, 2026 |
| K250550 | FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit | February 17, 2026 |
| K253568 | Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR | February 6, 2026 |
| K250863 | FUJIFILM Ultrasonic Endoscope EB-710US | December 12, 2025 |
| K251386 | ECHELON Synergy | September 17, 2025 |
| K244017 | FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000 | June 13, 2025 |
| K243512 | FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840T | June 10, 2025 |
| K243261 | FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC- | May 23, 2025 |
| K243762 | Synapse 3D Base Tools (V7.0) | May 21, 2025 |
| K250370 | SCENARIA View Phase 5.0 | May 20, 2025 |