Samsung Medison Co., Ltd.
FDA Regulatory Profile
Samsung Medison Co., Ltd. has 0 FDA recalls, 2 inspections, 75 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Dec 17, 2015 · NAI
- Latest 510(k)
- Oct 8, 2026
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 0 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 75 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 2 | Nov 9, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent FDA Inspections
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 3011847918 | Seoul, Korea (The Republic Of) | 1 | Dec 17, 2015 |
| FEI 3010289997 | Hongcheon, Korea (The Republic Of) | 1 | Dec 16, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K263150 | V10 Diagnostic Ultrasound System; cV10 Diagnostic Ultrasound System; H10 Diagnostic Ultrasound… | Oct 8, 2026 |
| K263182 | EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10 Diagnostic… | Sep 25, 2026 |
| K261412 | V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System… | Jul 28, 2026 |
| K254099 | EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10 Diagnostic… | Mar 27, 2026 |
| K252018 | HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic… | Jan 5, 2026 |
| K250999 | V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System… | Jul 18, 2025 |
| K243702 | V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System… | Feb 12, 2025 |
| K242511 | V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System… | Dec 10, 2024 |
| K242444 | HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System | Nov 27, 2024 |
| K241971 | HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System | Oct 11, 2024 |
| K241302 | SonoSync | Aug 23, 2024 |
| K240631 | V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System | Jun 21, 2024 |
| K240516 | RS85 Diagnostic Ultrasound System | Jun 12, 2024 |
| K233112 | HM70 EVO Diagnostic Ultrasound System | Dec 21, 2023 |
| K231772 | V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound… | Oct 3, 2023 |
| K230084 | HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System | Apr 21, 2023 |
| K223387 | V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System | Feb 13, 2023 |
| K221599 | HS40 Diagnostic Ultrasound System | Aug 22, 2022 |
| K220975 | V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System | Jun 29, 2022 |
| K221117 | RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System | Jun 17, 2022 |