Data / Medical devices / United States / View Point Medical, Inc.
View Point Medical, Inc.: FDA-registered device maker in Carlsbad, CA, United States, 1 510(k) clearance
View Point Medical, Inc. is registered with the FDA (registration 3021179744) in Carlsbad, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 16, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3021179744
- Address
- 6451 El Camino Real Ste A, Carlsbad, CA, United States, 92009
- Owner or operator
- Merit Medical Systems, Inc. (1721504)
- Roles
- Manufacturer
- First device listed
- April 28, 2026
- Registered through
- 2027
- Brand names listed
- OneMark Breast Localization Marker, OneMark DIS Console & Probe Activities: Manufacturer, OneMark DIS Probe 01, OneMark Detection Imaging System, OneMark Detector Console
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Marker, Radiographic, Implantable | NEU | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 16, 2024 | K241762 | OneMark | NEU | Substantially Equivalent | View Point Medical | accessdata.fda.gov |
Compare with other makers
Updated September 16, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.