Data / Medical devices / Injector, Contrast Medium, Automatic / United States
FDA-registered makers of Injector, Contrast Medium, Automatic in the United States: 6 establishments
6 establishments in the United States are registered with the FDA to make Injector, Contrast Medium, Automatic (product code IZQ). 3 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
- Injector, Contrast Medium, Automatic
- Product code
- IZQ
- Country
- United States
Makers of Injector, Contrast Medium, Automatic in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Acist Medical Systems, Inc. | Eden Prairie, MN, United States | Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer | 4 | August 3, 2026 | 0 | 0 | 0 | api.fda.gov |
| Bayer Medical Care Inc. | Indianola, PA, United States | Complaint file establishment, Manufacturer, Specification developer | 2 | November 5, 2024 | 0 | 0 | 0 | api.fda.gov |
| Liebel-Flarsheim Company LLC | Cincinnati, OH, United States | Manufacturer, Remanufacturer | 2 | January 14, 2016 | 0 | 3 | 0 | api.fda.gov |
| Bayer Medical Care Inc. | Pittsburgh, PA, United States | Contract manufacturer, Manufacturer, Manufacturer for export, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bayer Medical Care Inc. | Saxonburg, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Coeur, Inc.(a Wholly Owned Subsidiary Of Illinois Tool Works Inc.) | Washington, NC, 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.