Search FDA 510(k) Devices

4,872 clearances indexed · Search by device name, K-number, manufacturer or product code

40 results for "Samsung Electronics Co., Ltd."
1–24 of 40
Cleared Oct 01, 2024
GM85
K242651 · IZL
Samsung Electronics Co., Ltd.
Radiology · 27d
Cleared Sep 19, 2024
GF85 (models GF85-3P, GF85-SP)
K242478 · KPR
Samsung Electronics Co., Ltd.
Radiology · 29d
Cleared Aug 02, 2024
Samsung ECG App v 1.3 (ECG)
K240909 · QDA
Samsung Electronics Co., Ltd.
Cardiovascular · 122d
Not Cleared Feb 06, 2024
Sleep Apnea Feature
DEN230041 · QZW
Samsung Electronics Co., Ltd.
Anesthesiology · 251d
Cleared May 02, 2023
Samsung ECG Monitor Application with Irregular Heart Rhythm Notification
K230292 · QDA
Samsung Electronics Co., Ltd.
Cardiovascular · 89d
Cleared Sep 29, 2022
GM85
K222353 · IZL
Samsung Electronics Co., Ltd.
Radiology · 56d
Cleared Apr 21, 2022
GM85
K220175 · IZL
Samsung Electronics Co., Ltd.
Radiology · 90d
Cleared Apr 21, 2022
GEMS-H
K213452 · PHL
Samsung Electronics Co., Ltd.
Neurology · 177d
Cleared Nov 26, 2021
CUBE Air Purifier
K211139 · FRA
Samsung Electronics Co., Ltd.
General Hospital · 224d
Cleared Aug 31, 2021
Auto Lung Nodule Detection
K201560 · MYN
Samsung Electronics Co., Ltd.
Radiology · 447d
Cleared Aug 04, 2020
ECG Monitor App
K201168 · QDA
Samsung Electronics Co., Ltd.
Cardiovascular · 95d
Cleared Dec 07, 2018
GC70, GU60A, GU60A-65, GF50, GR50A
K182183 · KPR
Samsung Electronics Co., Ltd.
Radiology · 116d
Cleared Oct 24, 2018
GC70
K182647 · KPR
Samsung Electronics Co., Ltd.
Radiology · 30d
Cleared Oct 23, 2018
GU60A, GU60A-65
K182622 · KPR
Samsung Electronics Co., Ltd.
Radiology · 29d
Cleared Jul 20, 2018
GR40CW
K181631 · MQB
Samsung Electronics Co., Ltd.
Radiology · 30d
Cleared Jul 20, 2018
GC85A
K181629 · KPR
Samsung Electronics Co., Ltd.
Radiology · 30d
Cleared Jul 20, 2018
Digital Diagnostic Mobile X-ray System
K181626 · IZL
Samsung Electronics Co., Ltd.
Radiology · 30d
Cleared May 24, 2018
GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85
K180543 · KPR
Samsung Electronics Co., Ltd.
Radiology · 84d
Cleared Jan 12, 2018
GU60A & GU60A-65
K173828 · KPR
Samsung Electronics Co., Ltd.
Radiology · 25d
Cleared Nov 22, 2017
GC85A
K172229 · KPR
Samsung Electronics Co., Ltd.
Radiology · 120d
Cleared May 12, 2017
GM85
K171119 · IZL
Samsung Electronics Co., Ltd.
Radiology · 28d
Cleared Dec 07, 2016
GC70
K163115 · KPR
Samsung Electronics Co., Ltd.
Radiology · 30d
Cleared Nov 15, 2016
Digital Diagnostic Mobile X-ray System
K162278 · IZL
Samsung Electronics Co., Ltd.
Radiology · 92d
Cleared Jul 06, 2016
GC85A
K160997 · KPR
Samsung Electronics Co., Ltd.
Radiology · 86d