Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

43 results for "Samsung Electronics Co., Ltd."
1–24 of 43
Search insights Median review: 92d Cleared: 98% Top manufacturer: Samsung Electronics Co., Ltd. Lead specialty: Radiology
Cleared Aug 27, 2026
GC85A
K260481 · KPR
Samsung Electronics Co., Ltd.
Radiology · 195d
Cleared CT Jul 31, 2026
Hearing Aid Feature
K261187 · SCR
Samsung Electronics Co., Ltd.
Ear, Nose, Throat · 112d
Cleared Jul 20, 2026
Sleep Apnea Feature (v2.0)
K261011 · QZW
Samsung Electronics Co., Ltd.
Anesthesiology · 116d
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 CT 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