Samsung Medison Co., Ltd. (manufacturer, Gumi-si Gyeongbuk, KR): 13 new FDA device listings, incl. system, imaging, pulsed echo, ultrasonic
Samsung Medison Co., Ltd. (Gumi-si Gyeongbuk): 13 new FDA device listings, incl. system, imaging, pulsed echo, ultrasonic. Its amount of 13 is top-decile (95th percentile of 2,570 records). Dated 22 days ago, it is in the active follow-up window. Score 85/100. As of 2026-10-28, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 13 · 95th percentile of 2,570 DeviceEstablishmentPulse records · 13.0x the median
Free preview: all 14 published fields of this record are shown below. Locked: 116 related KR DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Samsung Medison Co., Ltd. |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | Gumi-si Gyeongbuk, KR |
| New listings | 13 |
| Devices | System, Imaging, Pulsed Echo, Ultrasonic; System, Imaging, Pulsed Doppler, Ultrasonic; System, Image Processing, Radiological; Transducer, Ultrasonic, Diagnostic; Automated Radiological Image Processing Software |
| Product codes | IYO, IYN, LLZ, ITX, QIH |
| Device classes | Class II |
| Medical specialties | Radiology |
| Brand names | XV10 ONE Diagnostic Ultrasound System; cV10 ONE Diagnostic Ultrasound System; XH10 Diagnostic Ultrasound System; XH10 ONE Diagnostic Ultrasound System; cV10 Diagnostic Ultrasound System; HERA Z10 Diagnostic Ultrasound System; V10 ONE Diagnostic Ultrasound System; XV10 Diagnostic Ultrasound System |
| First new listing | 2026-08-03 |
| Latest new listing | 2026-10-14 |
| FDA registration number | 3009758186 |
| Registration expires | 2027-12-31 |
| amount percentile | 95th of 2,570 (median 1, 13.0x median) |
| Peer records CSV (117 KR records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-10-14
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (KR first): Zapalign Inc. (foreign exporter, Anyang-si Gyeonggi, KR) · Samsung Medison Co., Ltd. (manufacturer, HONGCHEON-GUN Gangw · Osstem Implant Co.,Ltd. (manufacturer, Yeonsu-gu Incheon, KR · Boditech Med Inc. (manufacturer, Chuncheon Gangwon, KR) · Zimmer Biomet Korea Ltd. (foreign exporter, Seoul, KR) · Browse all by state and category →
LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 28 Oct 2026 20:51:27 GMT
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Peer benchmark and outreach value: Samsung Medison Co., Ltd. and 117 KR peers
- KR DeviceEstablishmentPulse records like this one: 117
- Samsung Medison Co., Ltd.'s amount: 95th percentile of 2,570 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every KR peer: $23,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
85 / 100 Score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- Listed in the last 45 days.
What is the DeviceEstablishmentPulse record for Samsung Medison Co., Ltd. in Gumi-si Gyeongbuk?
Samsung Medison Co., Ltd. (Gumi-si Gyeongbuk, KR), a manufacturer, added 13 FDA device listings between 2026-08-03 and 2026-10-14.
How does Samsung Medison Co., Ltd. compare to other DeviceEstablishmentPulse records?
This is a top-decile record: its amount of 13 is 13.0x the median of 1 across 2,570 records. It is 22 days old, still within a typical 45-day follow-up window. Its Score of 85/100 puts it among the stronger signals in this feed.
Samsung Medison Co., Ltd. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Samsung Medison Co., Ltd. | Gumi-si Gyeongbuk, KR | 13 | 95th | 2026-10-14 |
| Surgentec LLC | Boca Raton, FL | 15 | 96th | 2026-10-16 |
| Boston Scientific Corporation | Coventry, RI | 10 | 93rd | 2026-10-16 |
| Paragon 28 | Englewood, CO | 9 | 92nd | 2026-10-08 |
Related records
DeviceEstablishmentPulse: Manufacturer DeviceEstablishmentPulse: Foreign establishment
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From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.