Medicore Co., Ltd. FDA Record
Medicore Co., Ltd. has 0 FDA recalls, 1 inspection, 6 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Medicore Co., Ltd." is on file.
- Latest inspection
- Apr 25, 2019 · VAI
- Latest 510(k)
- Sep 13, 2021
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 6 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 1 | Nov 14, 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 |
|---|---|---|---|---|
| Apr 25, 2019 | Seongnam, Korea (The Republic Of) | Devices | Voluntary Action Indicated (VAI) | 2000010846 |
- 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 2000010846 | Seongnam, Korea (The Republic Of) | 1 | Apr 25, 2019 |
Medicore Co., Ltd. and the FDA: common questions
Has Medicore Co., Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Medicore 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 Medicore Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Medicore Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Medicore Co., Ltd.?
The most recent FDA inspection on file ended Apr 25, 2019 at Seongnam, Korea (The Republic Of) and was classified VAI. FDA has 1 inspection of Medicore Co., Ltd. on file.
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