Samsung Electronics Co L T D

FDA Filings

This page includes the latest FDA filings for Samsung Electronics Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3010300212
FEI Number3010300212
NameSamsung Electronics Co., Ltd.
Owner & OperatorSamsung Electronics Co., Ltd.
Contact Address129, Samsung-ro, Yeongtong-gu
Suwon-si KR-41 Gyeonggido 443-742 KR
Official Correspondent
  • ChulSin Kim
  • 82-31-2007661-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address129, Samsung-ro, Yeongtong-gu
Suwon-si Gyeonggido, 16677 KR
Establishment TypeManufacture Medical Device



Registration Number3004938766
FEI Number3004938766
NameNEUROLOGICA CORPORATION (SUBSIDIARY OF SAMSUNG ELECTRONICS)
Owner & OperatorSamsung Electronics Co., Ltd.
Contact Address129, Samsung-ro, Yeongtong-gu
Suwon-si KR-41 Gyeonggido 443-742 KR
Official Correspondent
  • ChulSin Kim
  • 82-31-2007661-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address14 ELECTRONICS AVENUE
Danvers, MA 01923 US
Establishment Type
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
Samsung Electronics Co., Ltd.
2022-05-12
Samsung Electronics Co., Ltd.
2022-05-12
Samsung Electronics Co. Ltd.
GM852022-04-21
Samsung Electronics Co., Ltd.
GEMS-H2022-04-21
Samsung Electronics Co., Ltd.
CUBE Air Purifier2021-11-26
Samsung Electronics Co., Ltd.
2021-10-11
Samsung Electronics Co., Ltd.
2021-10-11
Samsung Electronics Co., Ltd.
2021-10-11
Samsung Electronics Co., Ltd.
2021-10-11
Samsung Electronics Co., Ltd.
Samsung Health Body Composition 2021-09-15
Samsung Electronics Co., Ltd.
Samsung Health Body Composition 2021-09-15
Samsung Electronics Co.,Ltd.
Auto Lung Nodule Detection2021-08-31
Samsung Electronics Co., Ltd.
Samsung ECG Monitor Application 2020-10-02
Samsung Electronics Co., Ltd.
Samsung ECG Monitor Application 2020-10-02
Samsung Electronics Co., Ltd
ECG Monitor App2020-08-04
Samsung Electronics Co., Ltd.
2019-06-27
Samsung Electronics Co., Ltd.
2019-06-27
Samsung Electronics Co., Ltd.
2019-06-27
Samsung Electronics Co., Ltd.
2019-05-07
Samsung Electronics Co., Ltd.
2019-05-07
Samsung Electronics Co., Ltd.
2019-05-07
Samsung Electronics Co., Ltd.
2019-05-07
Samsung Electronics Co., Ltd.
GU60A2018-12-09
Samsung Electronics Co., Ltd.
GU60A-652018-12-09
Samsung Electronics Co., Ltd.
GR50A2018-12-09
Samsung Electronics Co., Ltd.
GR40CW2018-12-09
Samsung Electronics Co., Ltd.
GM852018-12-09
Samsung Electronics Co., Ltd.
GF502018-12-09
Samsung Electronics Co., Ltd.
GC85A2018-12-09
Samsung Electronics Co., Ltd.
GC702018-12-09
Samsung Electronics Co., Ltd.
GU60A2018-12-09
Samsung Electronics Co., Ltd.
GU60A-652018-12-09
Samsung Electronics Co., Ltd.
GR50A2018-12-09
Samsung Electronics Co., Ltd.
GR40CW2018-12-09
Samsung Electronics Co., Ltd.
GM852018-12-09
Samsung Electronics Co., Ltd.
GF502018-12-09
Samsung Electronics Co., Ltd.
GC85A2018-12-09
Samsung Electronics Co., Ltd.
GC702018-12-09
Samsung Electronics Co., Ltd.
GU60A2018-12-09
Samsung Electronics Co., Ltd.
GU60A-652018-12-09
Samsung Electronics Co., Ltd.
GR50A2018-12-09
Samsung Electronics Co., Ltd.
GR40CW2018-12-09
Samsung Electronics Co., Ltd.
GM852018-12-09
Samsung Electronics Co., Ltd.
GF502018-12-09
Samsung Electronics Co., Ltd.
GC85A2018-12-09
Samsung Electronics Co., Ltd.
GC702018-12-09
Samsung Electronics Co., LTD.
GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A2018-12-07
Samsung Electronics Co., Ltd.
GC702018-10-30
Samsung Electronics Co., Ltd.
GU60A2018-10-30
Samsung Electronics Co., Ltd.
GU60A-652018-10-30
Samsung Electronics Co., Ltd.
GU60A2018-10-30
Samsung Electronics Co., Ltd.
GU60A-652018-10-30
Samsung Electronics Co., Ltd.
GC702018-10-24
SAMSUNG ELECTRONICS CO., LTD.
GU60A, GU60A-652018-10-23
Samsung Electronics Co., Ltd.
GR40CWD2018-07-25
Samsung Electronics Co., Ltd.
GR40CWC2018-07-25
Samsung Electronics Co., Ltd.
GR40CW2018-07-25
Samsung Electronics Co., Ltd.
GR40CWD2018-07-25
Samsung Electronics Co., Ltd.
GR40CWC2018-07-25
Samsung Electronics Co., Ltd.
GR40CW2018-07-25
Samsung Electronics Co., Ltd.
GC85A2018-07-25
Samsung Electronics Co., Ltd.
GC85A with Prestige2018-07-25
Samsung Electronics Co., Ltd.
AccE GC85A2018-07-25
Samsung Electronics Co., Ltd.
GM852018-07-25
Samsung Electronics Co., Ltd.
GM85 with Prestige2018-07-25
Samsung Electronics Co., Ltd.
GM85 with Lite2018-07-25
Samsung Electronics Co., Ltd.
AccE GM852018-07-25
Samsung Electronics Co., Ltd.
GR40CW2018-07-20
Samsung Electronics Co., Ltd.
GC85A2018-07-20
Samsung Electronics Co., Ltd.
Digital Diagnostic Mobile X-ray System2018-07-20
Samsung Electronics Co.,Ltd.
GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, And GM852018-05-24
Samsung Electronics Co., Ltd.
GU60A2018-05-24
Samsung Electronics Co., Ltd.
GU60A-652018-05-24
Samsung Electronics Co., Ltd.
GR40CW2018-05-24
Samsung Electronics Co., Ltd.
GM852018-05-24
Samsung Electronics Co., Ltd.
GF50A2018-05-24
Samsung Electronics Co., Ltd.
GF502018-05-24
Samsung Electronics Co., Ltd.
GC702018-05-24
Samsung Electronics Co., Ltd.
GU60A2018-01-17
Samsung Electronics Co., Ltd.
GU60A-652018-01-17
Samsung Electronics Co., Ltd.
GU60A2018-01-17
Samsung Electronics Co., Ltd.
GU60A-652018-01-17
Samsung Electronics Co.,Ltd.
GU60A & GU60A-652018-01-12
Samsung Electronics Co., Ltd.
GC85A2017-12-11
NEUROLOGICA CORPORATION (SUBSIDIARY OF SAMSUNG ELECTRONICS) [Samsung Electronics Co., Ltd.]
CereTom Elite2017-12-05
Samsung Electronics Co.,Ltd.
GC85A2017-11-22
Samsung Electronics Co., Ltd.
Relumino2017-11-08
NEUROLOGICA CORPORATION (SUBSIDIARY OF SAMSUNG ELECTRONICS) [Samsung Electronics Co., Ltd.]
OmniTom2017-08-21
NEUROLOGICA CORPORATION (SUBSIDIARY OF SAMSUNG ELECTRONICS) [Samsung Electronics Co., Ltd.]
BodyTom Elite2017-06-22
NEUROLOGICA CORPORATION (SUBSIDIARY OF SAMSUNG ELECTRONICS) [Samsung Electronics Co., Ltd.]
GMR402017-05-24
Samsung Electronics Co., Ltd.
GM852017-05-15
Samsung Electronics Co., Ltd.
GM852017-05-15
Samsung Electronics Co.,Ltd.
GM852017-05-12
Samsung Electronics Co., Ltd.
GC702016-12-08
SAMSUNG ELECTRONICS CO., LTD.
GC702016-12-07
SAMSUNG ELECTRONICS CO., LTD.
Digital Diagnostic Mobile X-ray System2016-11-15
Samsung Electronics Co., Ltd.
GM852016-11-15
Samsung Electronics Co., Ltd.
GM852016-11-15
Samsung Electronics Co., Ltd.
GC85A2016-07-21
SAMSUNG ELECTRONICS CO., LTD.
GC85A2016-07-06
SAMSUNG ELECTRONICS CO., LTD.
GR40CW2015-12-21
Samsung Electronics Co., Ltd.
S4335-WV2015-12-21
Samsung Electronics Co., Ltd.
GR40CW2015-12-21
Samsung Electronics Co., Ltd.
S4343-W2015-10-18
Samsung Electronics Co., Ltd.
S3025-W2015-10-18
Samsung Electronics Co., Ltd.
GR40CW2015-10-18
SAMSUNG ELECTRONICS CO., LTD.
GR40CW2015-10-16
NEUROLOGICA CORPORATION (SUBSIDIARY OF SAMSUNG ELECTRONICS) [Samsung Electronics Co., Ltd.]
NExCT 72015-07-31
NEUROLOGICA CORPORATION (SUBSIDIARY OF SAMSUNG ELECTRONICS) [Samsung Electronics Co., Ltd.]
BodyTom2015-07-31
NEUROLOGICA CORPORATION (SUBSIDIARY OF SAMSUNG ELECTRONICS) [Samsung Electronics Co., Ltd.]
InSPira HD2015-07-31
Samsung Electronics Co., Ltd.
GU60A2015-07-20
Samsung Electronics Co., Ltd.
GU60A-652015-07-20
SAMSUNG ELECTRONICS CO., LTD.
GUA60A, GU60A-652015-07-17
SAMSUNG ELECTRONICS CO., LTD.
GF50A2015-06-23
Samsung Electronics Co., Ltd.
GF50A2015-06-23
Samsung Electronics Co., Ltd.
GC85A2015-04-05
SAMSUNG ELECTRONICS CO., LTD.
GC85A2015-04-02
Samsung Electronics Co., Ltd.
GM60A2015-02-22
Samsung Electronics Co., Ltd.
GM60A-40S2015-02-22
Samsung Electronics Co., Ltd.
GM60A-32S2015-02-22
SAMSUNG ELECTRONICS CO., LTD.
GM60A-32S & GM60A-40S2015-02-19
SAMSUNG ELECTRONICS CO., LTD.
Digital Diagnostic X-ray System (GC80)2015-02-04
Samsung Electronics Co., Ltd.
GC802015-02-04
Samsung Electronics Co., Ltd.
GM60A2014-12-23
Samsung Electronics Co., Ltd.
GM60A-40S2014-12-23
Samsung Electronics Co., Ltd.
GM60A-32S2014-12-23
SAMSUNG ELECTRONICS CO., LTD.
GM60A-32S, GM60A-40S2014-12-17
Samsung Electronics Co., Ltd.
XGEO GC802014-06-02
Samsung Electronics Co., Ltd.
GC802014-06-02
Samsung Electronics Co., Ltd.
XGEO GU60A2014-06-02
Samsung Electronics Co., Ltd.
GU60A2014-06-02
Samsung Electronics Co., Ltd.
XGEO GF502014-06-02
Samsung Electronics Co., Ltd.
GF502014-06-02
Samsung Electronics Co., Ltd.
XGEO GR40CW2014-06-02
Samsung Electronics Co., Ltd.
S4335-W2014-06-02
Samsung Electronics Co., Ltd.
GR40CW2014-06-02
SAMSUNG ELECTRONICS CO., LTD.
XGEO GF502014-05-29
SAMSUNG ELECTRONICS CO., LTD.
XGEO GC802014-05-28
SAMSUNG ELECTRONICS CO., LTD.
XGEO GU60A2014-05-28
SAMSUNG ELECTRONICS CO., LTD.
XGEO GR40CW2014-05-15
SAMSUNG ELECTRONICS CO., LTD.
S HEALTH2013-12-04
Samsung Electronics Co., Ltd.
XGEO GU60A2013-07-24
Samsung Electronics Co., Ltd.
GU60A2013-07-24
Samsung Electronics Co., Ltd.
XGEO GU602013-07-24
Samsung Electronics Co., Ltd.
GU602013-07-24
SAMSUNG ELECTRONICS CO., LTD.
DIGITAL DIAGNOSTIC X-RAY SYSTEM MODEL XGEO GU60A2013-06-20
SAMSUNG ELECTRONICS CO., LTD.
XGEO GU602013-06-07
Samsung Electronics Co., Ltd.
XGEO GC802013-02-20
Samsung Electronics Co., Ltd.
GC802013-02-20
SAMSUNG ELECTRONICS CO., LTD.
XGEO GC802013-01-18

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092915148Yantian,China (Mainland) -> Savannah, GeorgiaDISHWASHER158 CTN
2020092915144Yantian,China (Mainland) -> Savannah, GeorgiaDISHWASHER H S CODE 842211 THIS SHIPMENT CONT158 CTN
2020092915443Yantian,China (Mainland) -> Tampa, FloridaDISHWASHER H.S CODE :842211 THIS SHIPMENT CONTAINS NO SOLID WOOD PACKING MATERIALS NOTIFY PARTY 2: SAMSUNG ELECTRONICS AMERICA INC. 19925 INDEPENDENCE BLVD158 PCS
2020092915439Yantian,China (Mainland) -> Tampa, FloridaDISHWASHER H.S CODE :842211 THIS SHIPMENT CONTAINS NO SOLID WOOD PACKING MATERIALS FREIGHT PREPAID NOTIFY PARTY 2: SAMSUNG ELECTRONICS AMERICA INC.158 PCS
2020092915145Yantian,China (Mainland) -> Savannah, GeorgiaDISHWASHER H S CODE 842211 THIS SHIPMENT CONT158 CTN
2020092915440Yantian,China (Mainland) -> Tampa, FloridaDISHWASHER H.S CODE :842211 THIS SHIPMENT CONTAINS NO SOLID WOOD PACKING MATERIALS FREIGHT PREPAID NOTIFY PARTY 2: SAMSUNG ELECTRONICS AMERICA INC.158 PCS
2020092925538Yantian,China (Mainland) -> Long Beach, CaliforniaDISHWASHER - DISHWASHERH.S CODE :842211 SHIPP ER DECLARED THAT: THIS SHIPMENT CONTAINS NO S OLID WOOD PACKING MATERIALS158 CTN
2020092915142Yantian,China (Mainland) -> Savannah, GeorgiaDISHWASHER158 CTN

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