Radisen Co., Ltd.
Radisen Co., Ltd. has 0 FDA recalls, 2 inspections, 3 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Aug 4, 2026 · NAI
- Latest 510(k)
- Aug 19, 2022
Reviewing Radisen Co., Ltd. as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.
Or get Radisen Co., Ltd.'s full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site, in Claude, Cursor or ChatGPT.
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Oct 23, 2026 | Not stated | Current |
| 510(k) clearances | 3 | Oct 4, 2026 | Not stated | Current |
| Inspections | 2 | Oct 25, 2026 | Not stated | Current |
| Compliance actions | 0 | Oct 23, 2026 | Not stated | Current |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Aug 4, 2026 | Anyang, Korea (The Republic Of) | Devices | No Action Indicated (NAI) | 3017004860 |
| Dec 7, 2023 | Anyang, Korea (The Republic Of) | Devices | No Action Indicated (NAI) | 3017004860 |