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."
25–43 of 43
Search insights Median review: 92d Cleared: 98% Top manufacturer: Samsung Electronics Co., Ltd. Lead specialty: Radiology
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
Cleared Dec 21, 2015
GR40CW
K153401 · MQB
Samsung Electronics Co., Ltd.
Radiology · 27d
Cleared Oct 16, 2015
GR40CW
K152094 · MQB
Samsung Electronics Co., Ltd.
Radiology · 80d
Cleared Jul 17, 2015
GUA60A, GU60A-65
K151685 · KPR
Samsung Electronics Co., Ltd.
Radiology · 25d
Cleared Jun 23, 2015
GF50A
K151419 · KPR
Samsung Electronics Co., Ltd.
Radiology · 26d
Cleared Apr 02, 2015
GC85A
K150165 · KPR
Samsung Electronics Co., Ltd.
Radiology · 66d
Cleared Feb 19, 2015
GM60A-32S & GM60A-40S
K150097 · IZL
Samsung Electronics Co., Ltd.
Radiology · 30d
Cleared Feb 04, 2015
Digital Diagnostic X-ray System (GC80)
K143029 · KPR
Samsung Electronics Co., Ltd.
Radiology · 106d
Cleared Dec 17, 2014
GM60A-32S, GM60A-40S
K142492 · IZL
Samsung Electronics Co., Ltd.
Radiology · 104d
Cleared May 29, 2014
XGEO GF50
K140326 · KPR
Samsung Electronics Co., Ltd.
Radiology · 108d
Cleared May 28, 2014
XGEO GC80
K140334 · KPR
Samsung Electronics Co., Ltd.
Radiology · 107d
Cleared May 28, 2014
XGEO GU60A
K140332 · KPR
Samsung Electronics Co., Ltd.
Radiology · 107d
Cleared May 15, 2014
XGEO GR40CW
K140235 · MQB
Samsung Electronics Co., Ltd.
Radiology · 105d
Cleared Dec 04, 2013
S HEALTH
K132148 · DRG
Samsung Electronics Co., Ltd.
Cardiovascular · 146d
Cleared Jun 20, 2013
DIGITAL DIAGNOSTIC X-RAY SYSTEM MODEL XGEO GU60A
K123106 · KPR
Samsung Electronics Co., Ltd.
Radiology · 261d
Cleared Jun 07, 2013
XGEO GU60
K123105 · KPR
Samsung Electronics Co., Ltd.
Radiology · 248d
Cleared Jan 18, 2013
XGEO GC80
K123098 · KPR
Samsung Electronics Co., Ltd.
Radiology · 108d