Samsung Electronics Co., Ltd.
Samsung Electronics Co., Ltd. appears in FDA public data with 0 recalls, 43 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on August 27, 2026.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 43
- Inspections
- 1
- Compliance Actions
- 0
Known Names
samsung electronics co, samsung electronics
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K260481 | GC85A | August 27, 2026 |
| K261187 | Hearing Aid Feature | July 31, 2026 |
| K261011 | Sleep Apnea Feature (v2.0) | July 20, 2026 |
| K242651 | GM85 | October 1, 2024 |
| K242478 | GF85 (models GF85-3P, GF85-SP) | September 19, 2024 |
| K240909 | Samsung ECG App v 1.3 (ECG) | August 2, 2024 |
| DEN230041 | Sleep Apnea Feature | February 6, 2024 |
| K230292 | Samsung ECG Monitor Application with Irregular Heart Rhythm Notification | May 2, 2023 |
| K222353 | GM85 | September 29, 2022 |
| K220175 | GM85 | April 21, 2022 |
| K213452 | GEMS-H | April 21, 2022 |
| K211139 | CUBE Air Purifier | November 26, 2021 |
| K201560 | Auto Lung Nodule Detection | August 31, 2021 |
| K201168 | ECG Monitor App | August 4, 2020 |
| K182183 | GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A | December 7, 2018 |
| K182647 | GC70 | October 24, 2018 |
| K182622 | GU60A, GU60A-65 | October 23, 2018 |
| K181631 | GR40CW | July 20, 2018 |
| K181626 | Digital Diagnostic Mobile X-ray System | July 20, 2018 |
| K181629 | GC85A | July 20, 2018 |