Company ยท KR
Samsung Electronics Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2013 to 2026. Name variants (Inc, Corp, punctuation) are merged.
43510(k) clearances (3 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KPR | System, X-Ray, Stationary | 21 |
| IZL | System, X-Ray, Mobile | 8 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 4 |
| QDA | Electrocardiograph Software For Over-The-Counter Use | 3 |
| QZW | Over-The-Counter Device To Assess Risk Of Sleep Apnea | 2 |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 1 |
| FRA | Purifier, Air, Ultraviolet, Medical | 1 |
| MYN | Analyzer, Medical Image | 1 |
| PHL | Powered Exoskeleton | 1 |
| SCR | Air-Conduction Hearing Aid Software | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 27, 2026 | K260481 | GC85A Samsung Electronics Co., Ltd., KR | KPR |
| Jul 31, 2026 | K261187 | Hearing Aid Feature Samsung Electronics Co., Ltd., KR | SCR |
| Jul 20, 2026 | K261011 | Sleep Apnea Feature (v2.0) Samsung Electronics Co., Ltd., KR | QZW |
| Oct 1, 2024 | K242651 | GM85 Samsung Electronics Co., Ltd., KR | IZL |
| Sep 19, 2024 | K242478 | GF85 (models GF85-3P, GF85-SP) Samsung Electronics Co., Ltd., KR | KPR |
| Aug 2, 2024 | K240909 | Samsung ECG App v 1.3 (ECG) Samsung Electronics Co., Ltd., KR | QDA |
| Feb 6, 2024 | DEN230041 | Sleep Apnea Feature Samsung Electronics Co., Ltd., KR | QZW |
| May 2, 2023 | K230292 | Samsung ECG Monitor Application with Irregular Heart Rhythm Notification Samsung Electronics Co., Ltd., KR | QDA |
| Sep 29, 2022 | K222353 | GM85 Samsung Electronics Co., Ltd., KR | IZL |
| Apr 21, 2022 | K220175 | GM85 Samsung Electronics Co., Ltd., KR | IZL |
| Apr 21, 2022 | K213452 | GEMS-H Samsung Electronics Co., Ltd., KR | PHL |
| Nov 26, 2021 | K211139 | CUBE Air Purifier Samsung Electronics Co., Ltd., KR | FRA |
| Aug 31, 2021 | K201560 | Auto Lung Nodule Detection Samsung Electronics Co., Ltd., KR | MYN |
| Aug 4, 2020 | K201168 | ECG Monitor App Samsung Electronics Co., Ltd., KR | QDA |
| Dec 7, 2018 | K182183 | GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A Samsung Electronics Co., Ltd., KR | KPR |
| Oct 24, 2018 | K182647 | GC70 Samsung Electronics Co., Ltd., KR | KPR |
| Oct 23, 2018 | K182622 | GU60A, GU60A-65 Samsung Electronics Co., Ltd., KR | KPR |
| Jul 20, 2018 | K181631 | GR40CW Samsung Electronics Co., Ltd., KR | MQB |
| Jul 20, 2018 | K181629 | GC85A Samsung Electronics Co., Ltd., KR | KPR |
| Jul 20, 2018 | K181626 | Digital Diagnostic Mobile X-ray System Samsung Electronics Co., Ltd., KR | IZL |
| May 24, 2018 | K180543 | GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85 Samsung Electronics Co., Ltd., KR | KPR |
| Jan 12, 2018 | K173828 | GU60A & GU60A-65 Samsung Electronics Co., Ltd., KR | KPR |
| Nov 22, 2017 | K172229 | GC85A Samsung Electronics Co., Ltd., KR | KPR |
| May 12, 2017 | K171119 | GM85 Samsung Electronics Co., Ltd., KR | IZL |
| Dec 7, 2016 | K163115 | GC70 Samsung Electronics Co., Ltd., KR | KPR |
| Nov 15, 2016 | K162278 | Digital Diagnostic Mobile X-ray System Samsung Electronics Co., Ltd., KR | IZL |
| Jul 6, 2016 | K160997 | GC85A Samsung Electronics Co., Ltd., KR | KPR |
| Dec 21, 2015 | K153401 | GR40CW Samsung Electronics Co., Ltd., KR | MQB |
| Oct 16, 2015 | K152094 | GR40CW Samsung Electronics Co., Ltd., KR | MQB |
| Jul 17, 2015 | K151685 | GUA60A, GU60A-65 Samsung Electronics Co., Ltd., KR | KPR |
| Jun 23, 2015 | K151419 | GF50A Samsung Electronics Co., Ltd., KR | KPR |
| Apr 2, 2015 | K150165 | GC85A Samsung Electronics Co., Ltd., KR | KPR |
| Feb 19, 2015 | K150097 | GM60A-32S & GM60A-40S Samsung Electronics Co., Ltd., KR | IZL |
| Feb 4, 2015 | K143029 | Digital Diagnostic X-ray System (GC80) Samsung Electronics Co., Ltd., KR | KPR |
| Dec 17, 2014 | K142492 | GM60A-32S, GM60A-40S Samsung Electronics Co., Ltd., KR | IZL |
| May 29, 2014 | K140326 | XGEO GF50 Samsung Electronics Co., Ltd., KR | KPR |
| May 28, 2014 | K140334 | XGEO GC80 Samsung Electronics Co., Ltd., KR | KPR |
| May 28, 2014 | K140332 | XGEO GU60A Samsung Electronics Co., Ltd., KR | KPR |
| May 15, 2014 | K140235 | XGEO GR40CW Samsung Electronics Co., Ltd., KR | MQB |
| Dec 4, 2013 | K132148 | S HEALTH Samsung Electronics Co., Ltd., KR | DRG |
| Jun 20, 2013 | K123106 | DIGITAL DIAGNOSTIC X-RAY SYSTEM MODEL XGEO GU60A Samsung Electronics Co., Ltd. | KPR |
| Jun 7, 2013 | K123105 | XGEO GU60 Samsung Electronics Co., Ltd. | KPR |
| Jan 18, 2013 | K123098 | XGEO GC80 Samsung Electronics Co., Ltd. | KPR |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||