Samsung Electronics Co., Ltd.
42 FDA 510(k) clearances · Manufacturer
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| Record | Firm | Date |
|---|---|---|
| Hearing Aid Feature (K261187) | Samsung Electronics Co., Ltd. | 2026-07-31 |
| Sleep Apnea Feature (v2.0) (K261011) | Samsung Electronics Co., Ltd. | 2026-07-20 |
| GM85 (K242651) | Samsung Electronics Co., Ltd. | 2024-10-01 |
| GF85 (models GF85-3P, GF85-SP) (K242478) | Samsung Electronics Co., Ltd. | 2024-09-19 |
| Samsung ECG App v 1.3 (ECG) (K240909) | Samsung Electronics Co., Ltd. | 2024-08-02 |
| Sleep Apnea Feature (DEN230041) | Samsung Electronics Co., Ltd. | 2024-02-06 |
| Samsung ECG Monitor Application with Irregular Heart Rhythm Notification (K230292) | Samsung Electronics Co., Ltd. | 2023-05-02 |
| GM85 (K222353) | Samsung Electronics Co., Ltd. | 2022-09-29 |
| GEMS-H (K213452) | Samsung Electronics Co., Ltd. | 2022-04-21 |
| GM85 (K220175) | Samsung Electronics Co., Ltd. | 2022-04-21 |
| CUBE Air Purifier (K211139) | Samsung Electronics Co., Ltd. | 2021-11-26 |
| Auto Lung Nodule Detection (K201560) | Samsung Electronics Co., Ltd. | 2021-08-31 |
| ECG Monitor App (K201168) | Samsung Electronics Co., Ltd. | 2020-08-04 |
| GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A (K182183) | Samsung Electronics Co., Ltd. | 2018-12-07 |
| GC70 (K182647) | Samsung Electronics Co., Ltd. | 2018-10-24 |
| GU60A, GU60A-65 (K182622) | Samsung Electronics Co., Ltd. | 2018-10-23 |
| GR40CW (K181631) | Samsung Electronics Co., Ltd. | 2018-07-20 |
| Digital Diagnostic Mobile X-ray System (K181626) | Samsung Electronics Co., Ltd. | 2018-07-20 |
| GC85A (K181629) | Samsung Electronics Co., Ltd. | 2018-07-20 |
| GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85 (K180543) | Samsung Electronics Co., Ltd. | 2018-05-24 |
| GU60A & GU60A-65 (K173828) | Samsung Electronics Co., Ltd. | 2018-01-12 |
| GC85A (K172229) | Samsung Electronics Co., Ltd. | 2017-11-22 |
| GM85 (K171119) | Samsung Electronics Co., Ltd. | 2017-05-12 |
| GC70 (K163115) | Samsung Electronics Co., Ltd. | 2016-12-07 |
| Digital Diagnostic Mobile X-ray System (K162278) | Samsung Electronics Co., Ltd. | 2016-11-15 |
| GC85A (K160997) | Samsung Electronics Co., Ltd. | 2016-07-06 |
| GR40CW (K153401) | Samsung Electronics Co., Ltd. | 2015-12-21 |
| GR40CW (K152094) | Samsung Electronics Co., Ltd. | 2015-10-16 |
| GUA60A, GU60A-65 (K151685) | Samsung Electronics Co., Ltd. | 2015-07-17 |
| GF50A (K151419) | Samsung Electronics Co., Ltd. | 2015-06-23 |
| GC85A (K150165) | Samsung Electronics Co., Ltd. | 2015-04-02 |
| GM60A-32S & GM60A-40S (K150097) | Samsung Electronics Co., Ltd. | 2015-02-19 |
| Digital Diagnostic X-ray System (GC80) (K143029) | Samsung Electronics Co., Ltd. | 2015-02-04 |
| GM60A-32S, GM60A-40S (K142492) | Samsung Electronics Co., Ltd. | 2014-12-17 |
| XGEO GF50 (K140326) | Samsung Electronics Co., Ltd. | 2014-05-29 |
| XGEO GU60A (K140332) | Samsung Electronics Co., Ltd. | 2014-05-28 |
| XGEO GC80 (K140334) | Samsung Electronics Co., Ltd. | 2014-05-28 |
| XGEO GR40CW (K140235) | Samsung Electronics Co., Ltd. | 2014-05-15 |
| S HEALTH (K132148) | Samsung Electronics Co., Ltd. | 2013-12-04 |
| DIGITAL DIAGNOSTIC X-RAY SYSTEM MODEL XGEO GU60A (K123106) | Samsung Electronics Co., Ltd. | 2013-06-20 |
| XGEO GU60 (K123105) | Samsung Electronics Co., Ltd. | 2013-06-07 |
| XGEO GC80 (K123098) | Samsung Electronics Co., Ltd. | 2013-01-18 |
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