Siemens Healthineers Ltd. (manufacturer, Pohang-si Gyeongbuk, KR): 7 new FDA device listings, incl. catheter, ultrasound, intravascular
Siemens Healthineers Ltd. (Pohang-si Gyeongbuk): 7 new FDA device listings, incl. catheter, ultrasound, intravascular. Its amount of 7 is top-decile (90th percentile of 2,709 records). Dated 52 days ago, it serves as a historical benchmark. Score 75/100. As of 2026-11-04, 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: 7 · 90th percentile of 2,709 DeviceEstablishmentPulse records · 3.5x the median
Free preview: all 15 published fields of this record are shown below. Locked: 121 related KR DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Siemens Healthineers Ltd. |
| Owner / operator | Siemens Medical Solutions USA, Inc. |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device; Develop Specifications But Do Not Manufacture At This Facility |
| Location | Pohang-si Gyeongbuk, KR |
| New listings | 7 |
| Devices | Catheter, Ultrasound, Intravascular; Automated Radiological Image Processing Software; Biopsy Needle Guide Kit; System, Imaging, Pulsed Doppler, Ultrasonic; System, Imaging, Pulsed Echo, Ultrasonic; Transducer, Ultrasonic, Diagnostic |
| Product codes | OBJ, QIH, OIJ, IYN, IYO, ITX |
| Device classes | Class II |
| Medical specialties | Cardiovascular, Radiology |
| Brand names | ACUNAV Luxera 4D ICE Catheter; ACUSON Origin ICE Diagnostic Ultrasound System; ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System |
| First new listing | 2026-06-17 |
| Latest new listing | 2026-09-14 |
| FDA registration number | 3006985147 |
| Registration expires | 2026-12-31 |
| amount percentile | 90th of 2,709 (median 2, 3.5x median) |
| Peer records CSV (122 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: 2026-09-14
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 21:52:36 GMT
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Peer benchmark and outreach value: Siemens Healthineers Ltd. and 122 KR peers
- KR DeviceEstablishmentPulse records like this one: 122
- Siemens Healthineers Ltd.'s amount: 90th percentile of 2,709 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every KR peer: $24,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
75 / 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.
What is the DeviceEstablishmentPulse record for Siemens Healthineers Ltd. in Pohang-si Gyeongbuk?
Siemens Healthineers Ltd. (Pohang-si Gyeongbuk, KR), a manufacturer, added 7 FDA device listings between 2026-06-17 and 2026-09-14.
How does Siemens Healthineers Ltd. compare to other DeviceEstablishmentPulse records?
This is a top-decile record: its amount of 7 is 3.5x the median of 2 across 2,709 records. It is 52 days old; check the official source for later updates before acting. Its Score of 75/100 puts it among the stronger signals in this feed.
Siemens Healthineers Ltd. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Siemens Healthineers Ltd. | Pohang-si Gyeongbuk, KR | 7 | 90th | 2026-09-14 |
| Inter-Med, Inc. | Racine, WI | 5 | 86th | 2026-10-22 |
| Centerpoint Systems LLC | West Valley City, UT | 5 | 86th | 2026-10-21 |
| GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC | Waukesha, WI | 5 | 86th | 2026-10-19 |
Related records
- Applied Medical Resources Corp.
- Inter-Med, Inc.
- Intuitive Surgical, Inc.
- Biomerieux, Inc.
- Intuitive Surgical, Inc.
- Masimo Corporation
- Centerpoint Systems LLC
- Tornier, Inc.
- Treace Medical Concepts, Inc.
- Coopersurgical, Inc.
- GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC
- Boston Scientific Corporation
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.