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

Gumi-si Gyeongbuk, KR

SAMSUNG MEDISON CO., LTD. appears in FDA device records in Gumi-si Gyeongbuk, KR. FDA records list 73 510(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
73
PMA records
0
Recall records
0
Registered establishments
2

510(k) clearance history

Showing 50 of 73

FDA records hold 73 510(k) clearances for Samsung Medison Co., Ltd. between 2011 and 2026. The busiest year on record is 2019, with 9. The most recent is 2026, with 3.

Clearances by year, as a table
510(k) clearance decisions for Samsung Medison Co., Ltd., by decision year
YearClearances
20113
20121
20135
20144
20155
20164
20175
20187
20199
20204
20216
20225
20234
20246
20252
20263
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K261412V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System; V7/XV7/XH7/H7/cV7/V7 ONE/XV7 ONE/H7 ONE/XH7 ONE/cV7 ONE Diagnostic Ultrasound System; V6/XV6/XH6/H6/cV6/V6 ONE/XV6 ONE/H6 ONE/XH6 ONE/cV6 ONE Diagnostic Ultrasound System; V5/XV5/XH5/H5/cV5 Diagnostic Ultrasound System; V4/XV4/XH4/H4/cV4 Diagnostic Ultrasound System;IYNSubstantially Equivalent
K254099EVO 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 SystemIYNSubstantially Equivalent
K252018HERA 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 SystemIYNSubstantially Equivalent
K250999V8 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 SystemIYNSubstantially Equivalent
K243702V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound SystemIYNSubstantially Equivalent
K242511V5 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 SystemIYNSubstantially Equivalent
K242444HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemIYNSubstantially Equivalent
K241971HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound SystemIYNSubstantially Equivalent
K241302SonoSyncLLZSubstantially Equivalent
K240631V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound SystemIYNSubstantially Equivalent
K240516RS85 Diagnostic Ultrasound SystemIYNSubstantially Equivalent
K233112HM70 EVO Diagnostic Ultrasound SystemIYNSubstantially Equivalent
K231772V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound SystemIYNSubstantially Equivalent
K230084HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemIYNSubstantially Equivalent
K223387V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemIYNSubstantially Equivalent
K221599HS40 Diagnostic Ultrasound SystemIYNSubstantially Equivalent
K220975V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemIYNSubstantially Equivalent
K221117RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemIYNSubstantially Equivalent
K220269HM70 EVO Diagnostic Ultrasound SystemIYNSubstantially Equivalent
K220043HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound SystemIYNSubstantially Equivalent
K211824HERA W9, HERA W10 Diagnostic Ultrasound SystemIYNSubstantially Equivalent
K211945V8 Diagnostic Ultrasound SystemIYNSubstantially Equivalent
K210713HM70 EVO Diagnostic Ultrasound SystemIYNSubstantially Equivalent
K210959RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemIYNSubstantially Equivalent
K210426HS40 Diagnostic Ultrasound SystemIYNSubstantially Equivalent
K210068HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound SystemIYNSubstantially Equivalent
K202556HS30 Diagnostic Ultrasound SystemIYNSubstantially Equivalent
K200699HS70A Diagnostic Ultrasound SystemIYNSubstantially Equivalent
K200339HS40 Diagnostic Ultrasound SystemIYNSubstantially Equivalent
K192903RS85 Diagnostic Ultrasound SystemIYNSubstantially Equivalent
K192505HS50/HS60 Diagnostics Ultrasound SystemIYNSubstantially Equivalent
K192319HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound SystemIYNSubstantially Equivalent
K192030RS80 EVO Diagnostic Ultrasound SystemIYNSubstantially Equivalent
K191115RS85 Diagnostic Ultrasound SystemIYNSubstantially Equivalent
K191055HS40 Diagnostic Ultrasound SystemIYNSubstantially Equivalent
K190444HERA I10 Diagnostic Ultrasound SystemIYNSubstantially Equivalent
K182932RS85 Diagnostic Ultrasound SystemIYNSubstantially Equivalent
K182894HM70A Diagnostic Ultrasound SystemIYNSubstantially Equivalent
K182632HS30 Diagnostic Ultrasound SystemIYNSubstantially Equivalent
K182595HERA W10 Diagnostic Ultrasound SystemIYNSubstantially Equivalent
K181336HS50 / HS60 Diagnostic Ultrasound SystemIYNSubstantially Equivalent
K1808835D ViewerLLZSubstantially Equivalent
K180409HS40 Diagnostic Ultrasound SystemIYNSubstantially Equivalent
K173713HS70A Diagnostic Ultrasound SystemIYNSubstantially Equivalent
K173513WS80A Diagnostic Ultrasound SystemIYNSubstantially Equivalent
K173204RS85 Diagnostic Ultrasound SystemIYNSubstantially Equivalent
K171048RS80A Diagnostic Ultrasound SystemIYNSubstantially Equivalent
K171070WS80A Diagnostic Ultrasound SystemIYNSubstantially Equivalent
K172129HS40 Diagnostic Ultrasound SystemIYNSubstantially Equivalent
K170493HS50 / HS60 Diagnostic Ultrasound SystemIYNSubstantially Equivalent

Registered establishments

FDA registered establishments for Samsung Medison Co., Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30097581863009758186SAMSUNG MEDISON CO., LTD.244, 1gongdan-ro, Gumi-si Gyeongbuk 39376 KR2026
80411603010289997SAMSUNG MEDISON CO., LTD.3366, Hanseo-ro, Nam-myeon, HONGCHEON-GUN Gangwon 25108 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

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