Samsung Electronics Co., Ltd.
FDA 510(k) & PMA Approved Devices — 25 products
Total Devices25
Categories9
Latest FDA decision2026-07-31
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K261187 | Hearing Aid Feature | SCR | 2026-07-31 | View |
| 510(k) | K261011 | Sleep Apnea Feature (v2.0) | QZW | 2026-07-20 | View |
| 510(k) | K242651 | GM85 | IZL | 2024-10-01 | View |
| 510(k) | K242478 | GF85 (models GF85-3P, GF85-SP) | KPR | 2024-09-19 | View |
| 510(k) | K240909 | Samsung ECG App v 1.3 (ECG) | QDA | 2024-08-02 | View |
| 510(k) | K230292 | Samsung ECG Monitor Application with Irregular Heart Rhythm Notification | QDA | 2023-05-02 | View |
| 510(k) | K222353 | GM85 | IZL | 2022-09-29 | View |
| 510(k) | K213452 | GEMS-H | PHL | 2022-04-21 | View |
| 510(k) | K220175 | GM85 | IZL | 2022-04-21 | View |
| 510(k) | K211139 | CUBE Air Purifier | FRA | 2021-11-26 | View |
| 510(k) | K201560 | Auto Lung Nodule Detection | MYN | 2021-08-31 | View |
| 510(k) | K201168 | ECG Monitor App | QDA | 2020-08-04 | View |
| 510(k) | K182183 | GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A | KPR | 2018-12-07 | View |
| 510(k) | K182647 | GC70 | KPR | 2018-10-24 | View |
| 510(k) | K182622 | GU60A, GU60A-65 | KPR | 2018-10-23 | View |
| 510(k) | K181626 | Digital Diagnostic Mobile X-ray System | IZL | 2018-07-20 | View |
| 510(k) | K181629 | GC85A | KPR | 2018-07-20 | View |
| 510(k) | K181631 | GR40CW | MQB | 2018-07-20 | View |
| 510(k) | K180543 | GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85 | KPR | 2018-05-24 | View |
| 510(k) | K173828 | GU60A & GU60A-65 | KPR | 2018-01-12 | View |
No matching devices.
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