Data / Medical devices / System, X-Ray, Angiographic / United States
FDA-registered makers of System, X-Ray, Angiographic in the United States: 18 establishments
18 establishments in the United States are registered with the FDA to make System, X-Ray, Angiographic (product code IZI). 8 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- System, X-Ray, Angiographic
- Product code
- IZI
- Country
- United States
Makers of System, X-Ray, Angiographic in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Advance Medical Designs, Inc. | Marietta, GA, United States | Manufacturer, Repackager or relabeler | 1 | September 16, 1991 | 0 | 0 | 0 | api.fda.gov |
| Allwell Medical Corporation | Raleigh, NC, United States | Repackager or relabeler, Specification developer | 1 | September 16, 1991 | 0 | 0 | 0 | api.fda.gov |
| Argon Medical Devices Inc. | Athens, TX, United States | Manufacturer, Repackager or relabeler | 1 | September 16, 1991 | 0 | 1 | 0 | api.fda.gov |
| B. Braun Medical Inc. | Bethlehem, PA, United States | Specification developer | 1 | March 12, 1997 | 0 | 0 | 0 | api.fda.gov |
| Digital Surgery Systems, Inc | Goleta, CA, United States | Manufacturer | 1 | June 27, 2025 | 0 | 0 | 0 | api.fda.gov |
| Life Science Logistics, LLC | Brownsburg, IN, United States | Manufacturer, Repackager or relabeler | 1 | October 10, 2019 | 0 | 0 | 0 | api.fda.gov |
| Medline Industries (NAMIC Division) - Glen Falls | Glens Falls, NY, United States | Manufacturer | 1 | March 26, 1991 | 0 | 0 | 0 | api.fda.gov |
| Stryker Endoscopy | San Jose, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | May 28, 2026 | 0 | 0 | 0 | api.fda.gov |
| Arthrex, Inc. | Naples, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aspen Imaging Healthcare, Inc | Plano, TX, United States | Manufacturer, Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anholt Technologies Inc. | Avondale, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arthrex California Technology, Incorporated | Santa Barbara, CA, United States | Contract manufacturer, Contract sterilizer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arthrex Manufacturing Inc. | Pendleton, SC, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arthrex, Inc. | Ave Maria, FL, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| B. Braun Us Device Manufacturing LLC | Allentown, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carestream Health, Inc. | Rochester, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| IMRIS Imaging, Inc. | Chaska, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intuitive Surgical, Inc. | Sunnyvale, CA, United States | Specification developer | 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.