Insung Medical Co., Ltd. FDA Record
Insung Medical Co., Ltd. has 0 FDA recalls, 1 inspection, 1 510(k) clearance and 0 compliance actions on record. FDA has issued 1 warning letter to Insung Medical Co., Ltd., the most recent on Sep 23, 2025.
- Latest inspection
- May 1, 2025 · OAI
- Latest 510(k)
- Dec 28, 2020
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 1 | 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 |
Insung Medical Co., Ltd. FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Sep 23, 2025 | Medical Device Reporting/Misbranded | Center for Devices and Radiological Health |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| May 1, 2025 | Wonju, Korea (The Republic Of) | Devices | Official Action Indicated (OAI) | 3013023209 |
- 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 3013023209 | Wonju, Korea (The Republic Of) | 1 | May 1, 2025 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K200968 | ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R | Dec 28, 2020 |
Insung Medical Co., Ltd. and the FDA: common questions
Has Insung Medical Co., Ltd. received an FDA warning letter?
Yes. FDA has issued 1 warning letter to Insung Medical Co., Ltd.. The most recent is dated Sep 23, 2025, with the subject "Medical Device Reporting/Misbranded".
Has Insung Medical Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Insung Medical Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Insung Medical Co., Ltd.?
The most recent FDA inspection on file ended May 1, 2025 at Wonju, Korea (The Republic Of) and was classified OAI. FDA has 1 inspection of Insung Medical Co., Ltd. on file, 1 of them classified OAI (official action indicated).
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