Fujifilm Corporation
FDA Regulatory Profile
Fujifilm Corporation has 0 FDA recalls, 5 inspections, 71 510(k) clearances and 1 compliance action on record.
- Latest inspection
- Sep 22, 2023 · VAI
- Latest 510(k)
- Oct 9, 2026
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 0 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 71 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 5 | Nov 9, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Sep 22, 2023 | Ashigarakami-Gun, Japan | Devices | Voluntary Action Indicated (VAI) | 3001722928 |
| Sep 30, 2019 | Ashigarakami-Gun, Japan | Devices | Official Action Indicated (OAI) | 3001722928 |
| Jul 13, 2018 | Ashigarakami-Gun, Japan | Devices | No Action Indicated (NAI) | 3001722928 |
| Apr 25, 2013 | Ashigarakami-Gun, Japan | Devices | No Action Indicated (NAI) | 3001722928 |
| Jun 11, 2009 | Ashigarakami-Gun, Japan | Devices | No Action Indicated (NAI) | 3001722928 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 3001722928 | Ashigarakami-Gun, Japan | 5 | Sep 22, 2023 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K262902 | ECHELON Synergy | Oct 9, 2026 |
| K261229 | SCENARIA View Phase 6.0 | Sep 18, 2026 |
| K261283 | APERTO Lucent MRI System | Sep 16, 2026 |
| K253836 | FCT iStream Phase 2 | Sep 4, 2026 |
| K261170 | BA-004CC | Aug 12, 2026 |
| K260567 | EW10-EC02 Endoscopy Support Program | Aug 7, 2026 |
| K261880 | FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01 | Jul 2, 2026 |
| K253137 | FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T | Jun 16, 2026 |
| K254075 | Synapse Lung Nodule AI | May 27, 2026 |
| K254189 | Synapse 3D Base Tools (V7.2) | Apr 30, 2026 |
| K253862 | APERTO Lucent MRI System | Apr 6, 2026 |
| K251861 | FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model… | Mar 9, 2026 |
| K250550 | FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit | Feb 17, 2026 |
| K253568 | Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR | Feb 6, 2026 |
| K250863 | FUJIFILM Ultrasonic Endoscope EB-710US | Dec 12, 2025 |
| K251386 | ECHELON Synergy | Sep 17, 2025 |
| K244017 | FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000 | Jun 13, 2025 |
| K243512 | FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model… | Jun 10, 2025 |
| K243261 | FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model… | May 23, 2025 |
| K243762 | Synapse 3D Base Tools (V7.0) | May 21, 2025 |