Nuga Medical Co., Ltd. FDA Record
- Latest inspection VAI · Dec 8, 2022
- No warning letters matched by name
Nuga Medical Co., Ltd. has 0 FDA recalls, 3 inspections, 3 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Nuga Medical Co., Ltd." is on file.
- Latest inspection
- Dec 8, 2022 · VAI
- Latest 510(k)
- Sep 12, 2024
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 3 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 3 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
Nuga Medical Co., Ltd.: FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 1 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 1 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Dec 8, 2022 | Wonju, Korea (The Republic Of) | Devices | Voluntary Action Indicated (VAI) | 3004006265 |
| Jul 27, 2018 | Wonju, Korea (The Republic Of) | Devices | Voluntary Action Indicated (VAI) | 3004006265 |
| Aug 28, 2014 | Wonju, Korea (The Republic Of) | Devices | Official Action Indicated (OAI) | 3004006265 |
- 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 3004006265 | Wonju, Korea (The Republic Of) | 3 | Dec 8, 2022 |
Nuga Medical Co., Ltd. and the FDA: common questions
Has Nuga Medical Co., Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Nuga 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 Nuga Medical Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Nuga Medical Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Nuga Medical Co., Ltd.?
The most recent FDA inspection on file ended Dec 8, 2022 at Wonju, Korea (The Republic Of) and was classified VAI. FDA has 3 inspections of Nuga Medical Co., Ltd. on file, 1 of them classified OAI (official action indicated).
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