Unisis Corp.
Unisis Corp. has 0 FDA recalls, 5 inspections, 2 510(k) clearances and 1 compliance action on record.
- Latest inspection
- May 18, 2023 · OAI
- Latest 510(k)
- Jan 14, 2015
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Summary
| 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 | 2 | 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 |
|---|---|---|---|---|
| May 18, 2023 | Koshigaya, Japan | Devices | Official Action Indicated (OAI) | 3003803331 |
| Jan 23, 2020 | Koshigaya, Japan | Devices | Voluntary Action Indicated (VAI) | 3003803331 |
| Feb 19, 2016 | Koshigaya, Japan | Devices | No Action Indicated (NAI) | 3003803331 |
| Jul 3, 2013 | Koshigaya, Japan | Devices | No Action Indicated (NAI) | 3003803331 |
| May 17, 2012 | Koshigaya, Japan | Devices | Official Action Indicated (OAI) | 3003803331 |
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3003803331 | Koshigaya, Japan | 5 | May 18, 2023 |