Data / Medical devices / Marker, Radiographic, Implantable / United States
FDA-registered makers of Marker, Radiographic, Implantable in the United States: 37 establishments
37 establishments in the United States are registered with the FDA to make Marker, Radiographic, Implantable (product code NEU). 18 have a 510(k) clearance or PMA approval on file and 6 have a recall event. FDA data exported November 2, 2026.
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- Device
- Marker, Radiographic, Implantable
- Product code
- NEU
- Country
- United States
Makers of Marker, Radiographic, Implantable in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Hologic, Inc. | Marlborough, MA, United States | Complaint file establishment, Specification developer | 12 | September 26, 2019 | 0 | 3 | 2 | api.fda.gov |
| Bard Peripheral Vascular, Inc. | Tempe, AZ, United States | Complaint file establishment, Specification developer | 10 | March 24, 2025 | 0 | 1 | 0 | api.fda.gov |
| Devicor Medical Products, Inc. | Cincinnati, OH, United States | Specification developer | 8 | January 23, 2026 | 0 | 2 | 0 | api.fda.gov |
| Devicor Medical Products, Inc. Warehouse/Distribution/Service Center | Blue Ash, OH, United States | Remanufacturer, Repackager or relabeler | 7 | January 23, 2026 | 0 | 0 | 0 | api.fda.gov |
| Carbon Medical Technologies, Inc. | Saint Paul, MN, United States | Contract manufacturer, Manufacturer | 5 | July 23, 2025 | 0 | 1 | 0 | api.fda.gov |
| Merit Medical Systems, Inc. | South Jordan, UT, United States | Complaint file establishment, Manufacturer | 5 | December 19, 2025 | 0 | 1 | 0 | api.fda.gov |
| Elucent Medical Inc. | Eden Prairie, MN, United States | Manufacturer, Specification developer | 3 | December 20, 2024 | 0 | 1 | 0 | api.fda.gov |
| Breast-Med Inc. | Hopkins, MN, United States | Specification developer | 2 | December 12, 2025 | 0 | 0 | 0 | api.fda.gov |
| Merit Medical Systems, Inc. | Aliso Viejo, CA, United States | Specification developer | 2 | February 12, 2024 | 0 | 0 | 0 | api.fda.gov |
| RLS Interventional Inc. DBA Inrad | Grand Rapids, MI, United States | Manufacturer | 2 | November 7, 2024 | 0 | 0 | 0 | api.fda.gov |
| Argon Medical Devices Inc. | Athens, TX, United States | Contract manufacturer, Manufacturer | 1 | January 26, 2006 | 0 | 0 | 0 | api.fda.gov |
| C4 Imaging LLC | Bellaire, TX, United States | Specification developer | 1 | October 21, 2020 | 0 | 0 | 0 | api.fda.gov |
| Cortex Manufacturing, LLC | Byhalia, MS, United States | Manufacturer | 1 | January 12, 2011 | 0 | 0 | 0 | api.fda.gov |
| Covidien llc | Santa Clara, CA, United States | Specification developer | 1 | December 30, 2015 | 0 | 0 | 0 | api.fda.gov |
| Health Beacons, Inc. | Marlborough, MA, United States | Complaint file establishment, Specification developer | 1 | September 25, 2018 | 0 | 0 | 0 | api.fda.gov |
| Sonavex, Inc. | Baltimore, MD, United States | Manufacturer | 1 | June 6, 2018 | 0 | 0 | 0 | api.fda.gov |
| View Point Medical, Inc. | Carlsbad, CA, United States | Manufacturer | 1 | September 16, 2024 | 0 | 0 | 0 | api.fda.gov |
| Viscus Biologics, LLC. | Cleveland, OH, United States | Manufacturer | 1 | June 2, 2017 | 0 | 0 | 0 | api.fda.gov |
| A&m Biomedical Inc. | Laguna Hills, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Argon Medical Devices, Inc. | Wheeling, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bard Shannon Limited | Humacao, PR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomet, Inc. | Warsaw, IN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cirtronics Corporation | Milford, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Clarity Design, Inc. | Poway, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ei Microcircuits | Mankato, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Freudenberg Medical, LLC | Jeffersonville, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| I-Tek Medical, Inc. | White Bear Lake, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Keystone Manufacturing | Kalamazoo, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Modo Inc | Hillsboro, OR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Modo Inc. | Tualatin, OR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Packaging Compliance Medical, LLC | Kentwood, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Riverpoint Medical LLC | Portland, OR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ranfac Corp. | Avon, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tesco Associates, Inc. | Tyngsboro, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.