Cg Medtech Co., Ltd. FDA Record
Cg Medtech Co., Ltd. has 0 FDA recalls, 6 inspections, 2 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Cg Medtech Co., Ltd." is on file.
- Latest inspection
- Sep 8, 2026 · NAI
- Latest 510(k)
- Oct 28, 2025
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 2 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 6 | 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
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 1 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 1 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 1 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Sep 8, 2026 | Seongnam, Korea (The Republic Of) | Biologics | No Action Indicated (NAI) | 3006724198 |
| Jun 15, 2023 | Uijeongbu, Korea (The Republic Of) | Devices | Voluntary Action Indicated (VAI) | 3003200961 |
| Nov 14, 2019 | Uijeongbu, Korea (The Republic Of) | Devices | Voluntary Action Indicated (VAI) | 3003200961 |
| Mar 25, 2016 | Seongnam, Korea (The Republic Of) | Biologics | Voluntary Action Indicated (VAI) | 3006724198 |
| Feb 5, 2015 | Uijeongbu, Korea (The Republic Of) | Devices | Voluntary Action Indicated (VAI) | 3003200961 |
| Sep 25, 2009 | Seongnam, Korea (The Republic Of) | Biologics | Voluntary Action Indicated (VAI) | 3006724198 |
- 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 3006724198 | Seongnam, Korea (The Republic Of) | 3 | Sep 8, 2026 |
| FEI 3003200961 | Uijeongbu, Korea (The Republic Of) | 3 | Jun 15, 2023 |
Cg Medtech Co., Ltd. and the FDA: common questions
Has Cg Medtech Co., Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Cg Medtech 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 Cg Medtech Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Cg Medtech Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Cg Medtech Co., Ltd.?
The most recent FDA inspection on file ended Sep 8, 2026 at Seongnam, Korea (The Republic Of) and was classified NAI. FDA has 6 inspections of Cg Medtech Co., Ltd. on file.
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