FDA.reportPublic FDA data

Samsung Electronics America, Inc.

Matched from indexed company URL: SAMS, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
29512203003492170Samsung Electronics America, Inc.1Y2026-01-0185 Challenger Rd Ridgefield Park NJ US 07660
96800121000479488SAMSON INNOVATION CORP. LTD.1N2026-01-01ROOM F, 8/F, HOP HING INDUSTRIAL BLDG., 704 CASTLE PEAK RD., LAI CHI KOK, KOWLOON HK --
30049387663004938766Samsung HME America, Inc.1Y2026-01-0114 Electronics Ave Danvers MA US 01923
30052510153003046826Samsara Vision Inc.1Y2026-01-0127 US Highway 202 Suites 8 / 9 Far Hills NJ US 07931
30053477683005347768Samsara Vision Ltd.1N2026-01-0121 YEGIA KAPAYIM ST. Petah Tikva Central IL 4913020
30097581863009758186SAMSUNG MEDISON CO., LTD.1N2026-01-01244, 1gongdan-ro Gumi-si Gyeongbuk KR 39376
30103002123010300212Samsung Electronics Co., Ltd.1N2026-01-01129, Samsung-ro, Yeongtong-gu Suwon-si Gyeonggi KR 16677
30176163533017616353Samsung Electronics Co., Ltd. Mobile eXperience Business1N2026-01-01129, Samsung-ro, Yeongtong-gu Suwon-si Gyeonggi KR 16677
30321168903032116890SAMSUNG ELECTRONICS CO., LTD.1N2026-01-011077, Cheonho-daero, Gangdong-gu Seoul KR 05340
30032983793003298379SAMSONIC TRADING CO. INC.1Y2020-04-25160 WEST 28TH ST. Empire State NY US 10001

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
245911355600367P050034IMPLANTABLE MINIATURE TELESCOPE (IMT)NCJ2010-07-01
1589821099597214K254099EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10 Diagnostic Ultrasound System; EVO XQ30 Diagnostic Ultrasound System; EVO XQ20 Diagnostic Ultrasound System; EVO XQ10 Diagnostic Ultrasound System; EVO QH30 Diagnostic Ultrasound System; EVO QH20 Diagnostic Ultrasound System; EVO QH10 Diagnostic Ultrasound SystemIYN2026-03-27
1589821870412191K252018HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound SystemIYN2026-01-05
1589822058838103K250999V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound SystemIYN2025-07-18
1851511249089317K250928OmniTom Elite with PCDJAK2025-09-08
1589821617058686K243702V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound SystemIYN2025-02-12
1851511893954833K242811BodyTom 64JAK2025-03-14
1546891906881419K242651GM85IZL2024-10-01
3297121906881419K242651GM85IZL2024-10-01
1589821927729080K242511V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound SystemIYN2024-12-10
1546891630338542K242478GF85 (models GF85-3P, GF85-SP)KPR2024-09-19
3297121630338542K242478GF85 (models GF85-3P, GF85-SP)KPR2024-09-19
1589821379388075K242444HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemIYN2024-11-27
1589822019287039K241971HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound SystemIYN2024-10-11
2762401778199802K240909Samsung ECG App v 1.3 (ECG)QDA2024-08-02
1589821371206065K240631V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound SystemIYN2024-06-21
1589821491925418K240516RS85 Diagnostic Ultrasound SystemIYN2024-06-12
1851511425413547K233767OmniTom EliteJAK2024-06-10
1589821151022392K233112HM70 EVO Diagnostic Ultrasound SystemIYN2023-12-21
1589821426997687K231772V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound SystemIYN2023-10-03
2762401907417697K230292Samsung ECG Monitor Application with Irregular Heart Rhythm NotificationQDA2023-05-02
1589821400358812K230084HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemIYN2023-04-21
1851511233907927K223447OmniTom EliteJAK2023-06-01
1589821829779397K223387V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemIYN2023-02-13
1546891468236769K222353GM85IZL2022-09-29
3297121468236769K222353GM85IZL2022-09-29
1589821109229600K221599HS40 Diagnostic Ultrasound SystemIYN2022-08-22
1589821144264879K221117RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemIYN2022-06-17
1589821775163437K220975V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemIYN2022-06-29
1589821829735369K220269HM70 EVO Diagnostic Ultrasound SystemIYN2022-05-06
1546891765450527K220175GM85IZL2022-04-21
3297121765450527K220175GM85IZL2022-04-21
1589821664593115K220043HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound SystemIYN2022-04-05
1589822050794373K211945V8 Diagnostic Ultrasound SystemIYN2021-09-08
1589821166333751K211824HERA W9, HERA W10 Diagnostic Ultrasound SystemIYN2021-09-09
1851511430487483K211711OmniTom EliteJAK2022-02-25
1589822038132311K210959RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemIYN2021-06-24
1589821446418381K210713HM70 EVO Diagnostic Ultrasound SystemIYN2021-07-09
1589821853946395K210426HS40 Diagnostic Ultrasound SystemIYN2021-05-13
1589821888470964K210068HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound SystemIYN2021-04-09
1589821750996036K202556HS30 Diagnostic Ultrasound SystemIYN2020-10-30
1546891674564649K201560Auto Lung Nodule DetectionMYN2021-08-31
3297121674564649K201560Auto Lung Nodule DetectionMYN2021-08-31
2762401487029952K201168ECG Monitor AppQDA2020-08-04
1589821299013997K200699HS70A Diagnostic Ultrasound SystemIYN2020-05-07
1589821762245421K200339HS40 Diagnostic Ultrasound SystemIYN2020-04-07
1589821058865498K192903RS85 Diagnostic Ultrasound SystemIYN2020-01-06
1589821109512604K192505HS50/HS60 Diagnostics Ultrasound SystemIYN2019-12-12
1589821798113492K192319HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound SystemIYN2019-12-10
1589821011980045K192030RS80 EVO Diagnostic Ultrasound SystemIYN2019-09-19
1589821885829224K191115RS85 Diagnostic Ultrasound SystemIYN2019-06-12
1589821264391793K191055HS40 Diagnostic Ultrasound SystemIYN2019-06-12
1589821206131491K190444HERA I10 Diagnostic Ultrasound SystemIYN2019-05-22
1589821290124925K182932RS85 Diagnostic Ultrasound SystemIYN2019-02-15
1589821196632914K182894HM70A Diagnostic Ultrasound SystemIYN2019-01-22
1546891565459604K182647GC70KPR2018-10-24
1589821634743947K182632HS30 Diagnostic Ultrasound SystemIYN2019-01-08
1546891923382047K182622GU60A, GU60A-65KPR2018-10-23
1589821374329923K182595HERA W10 Diagnostic Ultrasound SystemIYN2018-12-18
1546892071627563K182183GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85AKPR2018-12-07
3297122071627563K182183GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85AKPR2018-12-07
1546891067824995K181631GR40CWMQB2018-07-20
3297121067824995K181631GR40CWMQB2018-07-20
1546892058711707K181629GC85AKPR2018-07-20
3297122058711707K181629GC85AKPR2018-07-20
1546891783332630K181626Digital Diagnostic Mobile X-ray SystemIZL2018-07-20
3297121783332630K181626Digital Diagnostic Mobile X-ray SystemIZL2018-07-20
1589821898528785K181336HS50 / HS60 Diagnostic Ultrasound SystemIYN2018-12-04
1589821779925571K1808835D ViewerLLZ2018-05-15
1546891616418472K180543GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85KPR2018-05-24
3297121616418472K180543GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85KPR2018-05-24
1589821351270061K180409HS40 Diagnostic Ultrasound SystemIYN2018-05-11
1546891239506234K173828GU60A & GU60A-65KPR2018-01-12
1589821656728394K173713HS70A Diagnostic Ultrasound SystemIYN2018-03-08
1589821202883056K173513WS80A Diagnostic Ultrasound SystemIYN2018-02-20
1589821951153992K173204RS85 Diagnostic Ultrasound SystemIYN2018-02-05
1851511478984477K172539CereTom EliteJAK2017-11-22
1546891006842596K172229GC85AKPR2017-11-22
3297121006842596K172229GC85AKPR2017-11-22
1589822067727117K172129HS40 Diagnostic Ultrasound SystemIYN2017-08-08
1851511031034050K171183OmniTomJAK2017-08-18
1546892043075914K171119GM85IZL2017-05-12
3297122043075914K171119GM85IZL2017-05-12
1851511629028626K171085GMR40MQB2017-05-11
1589821924771774K171070WS80A Diagnostic Ultrasound SystemIYN2017-08-09
1589821532859836K171048RS80A Diagnostic Ultrasound SystemIYN2017-08-24
1589821078317780K170493HS50 / HS60 Diagnostic Ultrasound SystemIYN2017-03-28
1851511183029559K170238BodyTom EliteJAK2017-06-14
1589821556741344K163691HS70A Diagnostic Ultrasound SystemIYN2017-02-22
1546891761156130K163115GC70KPR2016-12-07
1546891749725160K162278Digital Diagnostic Mobile X-ray SystemIZL2016-11-15
3297121749725160K162278Digital Diagnostic Mobile X-ray SystemIZL2016-11-15
1589821157044564K162094RS80A Diagnostic Ultrasound SystemIYN2016-08-26
1589821594581635K1619555D ViewerLLZ2016-08-10
1546891492410685K160997GC85AKPR2016-07-06
3297121492410685K160997GC85AKPR2016-07-06
1589821916035242K153539RS80A Diagnostic Ultrasound SystemIYN2016-10-03
1589821381111482K153529WS80A Diagnostic Ultrasound SystemIYN2016-02-02
1589821490153517K153408HM70A Diagnostic Ultrasound SystemIYN2015-12-21
1546891861726307K153401GR40CWMQB2015-12-21
3297121861726307K153401GR40CWMQB2015-12-21
1589821726102702K152962HS70A Diagnostic Ultrasound SystemIYN2015-11-02
1546891328030606K152094GR40CWMQB2015-10-16
3297121328030606K152094GR40CWMQB2015-10-16
1589821623571948K1518083D/5D ViewerLLZ2015-07-29
1546891636988254K151685GUA60A, GU60A-65KPR2015-07-17
1589821226510040K151663RS80A Diagnostic Ultrasound SystemIYN2015-08-12
1546891141341918K151419GF50AKPR2015-06-23

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IYN812026-03-27
KPR332024-09-19
IZL172024-10-01
MQB132018-07-20
JAK112025-09-08
LLZ42018-05-15
QDA32024-08-02
ITX32011-01-05
MYN22021-08-31
NCJ22010-07-01
QZW12024-02-06
IYO12013-08-20
KPS12009-08-27

NDC#

CEFAZOLIN

Samson Medical Technologies, L.L.C.

CEFAZOLIN SODIUM

CEFAZOLIN

Samson Medical Technologies, L.L.C.

CEFAZOLIN SODIUM

Cefoxitin

SAMSON MEDICAL TECHNOLOGIES LLC

cefoxitin

Ceftriaxone

Samson Medical Technologies, LLC

Ceftriaxone Sodium

CEFEPIME

SAMSON MEDICAL TECHNOLOGIES LLC

CEFEPIME

PMN#

GM85

2024-10-01

Samsung Electronics Co., Ltd.

SonoSync

2024-08-23

Samsung Medison Co., Ltd.

GM85

2022-09-29

Samsung Electronics Co., LTD.

GEMS-H

2022-04-21

Samsung Electronics Co., Ltd.

GM85

2022-04-21

Samsung Electronics Co. Ltd.

123 records. Showing 1-40. Next

Applications#

GUDID#

Samsung ECG App v 1.3 (ECG) - The ECG Monitor App intended for adults 22 years and older analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of AFib and provides a notification suggesting the user record an ECG to analyze the heart rhythm. The IHRN feature is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically acquire pulse rate data when the user is still and analyze the data when determined sufficient toward surfacing a notification. The ECG Monitor App is not intended to replace traditional methods of diagnosis or treatment. The ECG app is not intended for users with known arrhythmias other than AFib or users under 22 years old. Users should not interpret or take clinical action based on the device output without consultation of a qualified healthcare professional.

Samsung Electronics Co., Ltd.

2025-06-10

Samsung ECG App v 1.3 (ECG) - The ECG Monitor App intended for adults 22 years and older analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of AFib and provides a notification suggesting the user record an ECG to analyze the heart rhythm. The IHRN feature is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically acquire pulse rate data when the user is still and analyze the data when determined sufficient toward surfacing a notification. The ECG Monitor App is not intended to replace traditional methods of diagnosis or treatment. The ECG app is not intended for users with known arrhythmias other than AFib or users under 22 years old. Users should not interpret or take clinical action based on the device output without consultation of a qualified healthcare professional.

Samsung Electronics Co., Ltd.

2025-06-10

Samsung ECG Monitor Application with Irregular Heart Rhythm Notification - The Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone for informational use only in adults 22 years and older. The app analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provides a notification suggesting the user record an ECG to analyze the heart rhythm. The Irregular Heart Rhythm Notification Feature is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically acquire pulse rate data when the user is still and analyze the data when determined sufficient toward surfacing a notification.

Samsung Electronics Co., Ltd.

2023-10-23

Samsung ECG Monitor Application with Irregular Heart Rhythm Notification - The Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone for informational use only in adults 22 years and older. The app analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provides a notification suggesting the user record an ECG to analyze the heart rhythm. The Irregular Heart Rhythm Notification Feature is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically acquire pulse rate data when the user is still and analyze the data when determined sufficient toward surfacing a notification.

Samsung Electronics Co., Ltd.

2023-10-23

miniER7

SAMSUNG MEDISON CO., LTD.

2025-09-03

LM2-18D

SAMSUNG MEDISON CO., LTD.

2025-09-03

LA3-16AD

SAMSUNG MEDISON CO., LTD.

2025-09-03

80 records. Showing 1-40. Next