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Samsung Electronics Co., Ltd. FDA Approvals
0 new drug approvals and 13 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| GC85A510(k)Aug 27, 2026Radiology |
| Hearing Aid Feature510(k)Jul 31, 2026Ear, Nose, Throat |
| Sleep Apnea Feature (v2.0)510(k)Jul 20, 2026Anesthesiology |
| GM85510(k)Oct 1, 2024Radiology |
| GF85 (models GF85-3P, GF85-SP)510(k)Sep 19, 2024Radiology |
| Samsung ECG App v 1.3 (ECG)510(k)Aug 2, 2024Cardiovascular |
| Sleep Apnea Feature510(k)Feb 6, 2024Anesthesiology |
| Samsung ECG Monitor Application with Irregular Heart Rhythm Notification510(k)May 2, 2023Cardiovascular |
| GM85510(k)Sep 29, 2022Radiology |
| GEMS-H510(k)Apr 21, 2022Physical Medicine |
| GM85510(k)Apr 21, 2022Radiology |
| CUBE Air Purifier510(k)Nov 26, 2021General Hospital |
| Auto Lung Nodule Detection510(k)Aug 31, 2021Radiology |