Sewoon Medical Co., Ltd. FDA Record
- Latest inspection OAI · Feb 20, 2025
- No warning letters matched by name
Sewoon Medical Co., Ltd. has 0 FDA recalls, 2 inspections, 1 510(k) clearance and 0 compliance actions on record. No FDA warning letter addressed to "Sewoon Medical Co., Ltd." is on file.
- Latest inspection
- Feb 20, 2025 · OAI
- Latest 510(k)
- Feb 15, 2002
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 1 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 2 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Feb 20, 2025 | Cheonan, Korea (The Republic Of) | Devices | Official Action Indicated (OAI) | 3000247987 |
| Jun 23, 2011 | Cheonan, Korea (The Republic Of) | Devices | Voluntary Action Indicated (VAI) | 3000247987 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3000247987 | Cheonan, Korea (The Republic Of) | 2 | Feb 20, 2025 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K013276 | ALL-SILICONE FOLEY BALLOON CATHETER (TWO WAY; THREE WAY, RADIOPAQUE) | Feb 15, 2002 |
Sewoon Medical Co., Ltd. and the FDA: common questions
Has Sewoon Medical Co., Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Sewoon Medical Co., Ltd." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Sewoon Medical Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Sewoon Medical Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Sewoon Medical Co., Ltd.?
The most recent FDA inspection on file ended Feb 20, 2025 at Cheonan, Korea (The Republic Of) and was classified OAI. FDA has 2 inspections of Sewoon Medical Co., Ltd. on file, 1 of them classified OAI (official action indicated).
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