Samsung Electronics Co., Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 40
- Inspections
- 1
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| 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 |
| K180543 | GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85 | May 24, 2018 |
| K173828 | GU60A & GU60A-65 | January 12, 2018 |
| K172229 | GC85A | November 22, 2017 |