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

75 results for "Samsung Medison Co., Ltd."
1–24 of 75
Search insights Median review: 83d Cleared: 100% Top manufacturer: Samsung Medison Co., Ltd. Lead specialty: Radiology
Cleared Oct 08, 2026
V10 Diagnostic Ultrasound System
K263150 · IYN
Samsung Medison Co., Ltd.
Radiology · 30d
Cleared Sep 25, 2026
EVO X30 Diagnostic Ultrasound System
K263182 · IYN
Samsung Medison Co., Ltd.
Radiology · 14d
Cleared Jul 28, 2026
V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound...
K261412 · IYN
Samsung Medison Co., Ltd.
Radiology · 89d
Cleared Mar 27, 2026
EVO Q30 Diagnostic Ultrasound System
K254099 · IYN
Samsung Medison Co., Ltd.
Radiology · 98d
Cleared Jan 05, 2026
HERA Z20 Diagnostic Ultrasound System
K252018 · IYN
Samsung Medison Co., Ltd.
Radiology · 189d
Cleared Jul 18, 2025
V8 Diagnostic Ultrasound System
K250999 · IYN
Samsung Medison Co., Ltd.
Radiology · 108d
Cleared Feb 12, 2025
V8 Diagnostic Ultrasound System
K243702 · IYN
Samsung Medison Co., Ltd.
Radiology · 75d
Cleared Dec 10, 2024
V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5...
K242511 · IYN
Samsung Medison Co., Ltd.
Radiology · 109d
Cleared Nov 27, 2024
HERA W10 Diagnostic Ultrasound System
K242444 · IYN
Samsung Medison Co., Ltd.
Radiology · 103d
Cleared Oct 11, 2024
HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System
K241971 · IYN
Samsung Medison Co., Ltd.
Radiology · 98d
Cleared Aug 23, 2024
SonoSync
K241302 · LLZ
Samsung Medison Co., Ltd.
Radiology · 106d
Cleared Jun 21, 2024
V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System
K240631 · IYN
Samsung Medison Co., Ltd.
Radiology · 107d
Cleared Jun 12, 2024
RS85 Diagnostic Ultrasound System
K240516 · IYN
Samsung Medison Co., Ltd.
Radiology · 110d
Cleared Dec 21, 2023
HM70 EVO Diagnostic Ultrasound System
K233112 · IYN
Samsung Medison Co., Ltd.
Radiology · 85d
Cleared Oct 03, 2023
V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6...
K231772 · IYN
Samsung Medison Co., Ltd.
Radiology · 109d
Cleared Apr 21, 2023
HERA W10 Diagnostic Ultrasound System
K230084 · IYN
Samsung Medison Co., Ltd.
Radiology · 100d
Cleared Feb 13, 2023
V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System
K223387 · IYN
Samsung Medison Co., Ltd.
Radiology · 98d
Cleared Aug 22, 2022
HS40 Diagnostic Ultrasound System
K221599 · IYN
Samsung Medison Co., Ltd.
Radiology · 81d
Cleared Jun 29, 2022
V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System
K220975 · IYN
Samsung Medison Co., Ltd.
Radiology · 86d
Cleared Jun 17, 2022
RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System
K221117 · IYN
Samsung Medison Co., Ltd.
Radiology · 60d
Cleared May 06, 2022
HM70 EVO Diagnostic Ultrasound System
K220269 · IYN
Samsung Medison Co., Ltd.
Radiology · 95d
Cleared Apr 05, 2022
HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound System
K220043 · IYN
Samsung Medison Co., Ltd.
Radiology · 90d
Cleared Sep 09, 2021
HERA W9, HERA W10 Diagnostic Ultrasound System
K211824 · IYN
Samsung Medison Co., Ltd.
Radiology · 87d
Cleared Sep 08, 2021
V8 Diagnostic Ultrasound System
K211945 · IYN
Samsung Medison Co., Ltd.
Radiology · 77d