510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Samsung Electronics Co., Ltd.

Suwon-si Gyeonggi, KR

SAMSUNG ELECTRONICS CO., LTD. appears in FDA device records in Suwon-si Gyeonggi, KR. FDA records list 42 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
42
PMA records
0
Recall records
0
Registered establishments
2

510(k) clearance history

FDA records hold 42 510(k) clearances for Samsung Electronics Co., Ltd. between 2013 and 2026. The busiest year on record is 2018, with 8. The most recent is 2026, with 2.

Clearances by year, as a table
510(k) clearance decisions for Samsung Electronics Co., Ltd., by decision year
YearClearances
20134
20145
20157
20163
20172
20188
20201
20212
20223
20231
20244
20262
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K261187Hearing Aid FeatureSCRSubstantially Equivalent
K261011Sleep Apnea Feature (v2.0)QZWSubstantially Equivalent
K242651GM85IZLSubstantially Equivalent
K242478GF85 (models GF85-3P, GF85-SP)KPRSubstantially Equivalent
K240909Samsung ECG App v 1.3 (ECG)QDASubstantially Equivalent
DEN230041Sleep Apnea FeatureQZWUnknown
K230292Samsung ECG Monitor Application with Irregular Heart Rhythm NotificationQDASubstantially Equivalent
K222353GM85IZLSubstantially Equivalent
K220175GM85IZLSubstantially Equivalent
K213452GEMS-HPHLSubstantially Equivalent
K211139CUBE Air PurifierFRASubstantially Equivalent
K201560Auto Lung Nodule DetectionMYNSubstantially Equivalent
K201168ECG Monitor AppQDASubstantially Equivalent
K182183GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85AKPRSubstantially Equivalent
K182647GC70KPRSubstantially Equivalent
K182622GU60A, GU60A-65KPRSubstantially Equivalent
K181631GR40CWMQBSubstantially Equivalent
K181629GC85AKPRSubstantially Equivalent
K181626Digital Diagnostic Mobile X-ray SystemIZLSubstantially Equivalent
K180543GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85KPRSubstantially Equivalent
K173828GU60A & GU60A-65KPRSubstantially Equivalent
K172229GC85AKPRSubstantially Equivalent
K171119GM85IZLSubstantially Equivalent
K163115GC70KPRSubstantially Equivalent
K162278Digital Diagnostic Mobile X-ray SystemIZLSubstantially Equivalent
K160997GC85AKPRSubstantially Equivalent
K153401GR40CWMQBSubstantially Equivalent
K152094GR40CWMQBSubstantially Equivalent
K151685GUA60A, GU60A-65KPRSubstantially Equivalent
K151419GF50AKPRSubstantially Equivalent
K150165GC85AKPRSubstantially Equivalent
K150097GM60A-32S & GM60A-40SIZLSubstantially Equivalent
K143029Digital Diagnostic X-ray System (GC80)KPRSubstantially Equivalent
K142492GM60A-32S, GM60A-40SIZLSubstantially Equivalent
K140326XGEO GF50KPRSubstantially Equivalent
K140334XGEO GC80KPRSubstantially Equivalent
K140332XGEO GU60AKPRSubstantially Equivalent
K140235XGEO GR40CWMQBSubstantially Equivalent
K132148S HEALTHDRGSubstantially Equivalent
K123106DIGITAL DIAGNOSTIC X-RAY SYSTEM MODEL XGEO GU60AKPRSubstantially Equivalent
K123105XGEO GU60KPRSubstantially Equivalent
K123098XGEO GC80KPRSubstantially Equivalent

Registered establishments

FDA registered establishments for Samsung Electronics Co., Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30321168903032116890SAMSUNG ELECTRONICS CO., LTD.1077, Cheonho-daero, Gangdong-gu, Seoul 05340 KR2026
30103002123010300212Samsung Electronics Co., Ltd.129, Samsung-ro, Yeongtong-gu, Suwon-si Gyeonggi 16677 KR2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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Data as of , FDA export datePage updated Source: openFDA, public domain