Samsung Electronics Co., Ltd.
Samsung Electronics Co., Ltd. holds FDA 510(k) medical device clearances, first cleared 2013, most recent 2026.
Top product codes for Samsung Electronics Co., Ltd.
Recent clearances by Samsung Electronics Co., Ltd.
- K260481 — GC85A
- K261187 — Hearing Aid Feature
- K261011 — Sleep Apnea Feature (v2.0)
- K242651 — GM85
- K242478 — GF85 (models GF85-3P, GF85-SP)
- K240909 — Samsung ECG App v 1.3 (ECG)
- DEN230041 — Sleep Apnea Feature
- K230292 — Samsung ECG Monitor Application with Irregular Heart Rhythm Notification
- K222353 — GM85
- K213452 — GEMS-H
- K220175 — GM85
- K211139 — CUBE Air Purifier
- K201560 — Auto Lung Nodule Detection
- K201168 — ECG Monitor App
- K182183 — GC70, GU60A, GU60A-65, GF50, GR50A; GR40CW; GM85; GC85A
- K182647 — GC70
- K182622 — GU60A, GU60A-65
- K181626 — Digital Diagnostic Mobile X-ray System
- K181629 — GC85A
- K181631 — GR40CW
- K180543 — GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85
- K173828 — GU60A & GU60A-65
- K172229 — GC85A
- K171119 — GM85
- K163115 — GC70
- K162278 — Digital Diagnostic Mobile X-ray System
- K160997 — GC85A
- K153401 — GR40CW
- K152094 — GR40CW
- K151685 — GUA60A, GU60A-65
- K151419 — GF50A
- K150165 — GC85A
- K150097 — GM60A-32S & GM60A-40S
- K143029 — Digital Diagnostic X-ray System (GC80)
- K142492 — GM60A-32S, GM60A-40S
- K140326 — XGEO GF50
- K140332 — XGEO GU60A
- K140334 — XGEO GC80
- K140235 — XGEO GR40CW
- K132148 — S HEALTH
- K123106 — DIGITAL DIAGNOSTIC X-RAY SYSTEM MODEL XGEO GU60A
- K123105 — XGEO GU60
- K123098 — XGEO GC80
Data sourced from openFDA. This site is unofficial and independent of the FDA.