Data / Medical devices / Injector, Contrast Medium, Automatic
Injector, Contrast Medium, Automatic (IZQ): 24 FDA-registered makers in 12 countries
24 establishments in 12 countries are registered with the FDA to make Injector, Contrast Medium, Automatic (product code IZQ, Class 2, 21 CFR 870.1650). 7 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 23 510(k) clearances under this code, the latest on August 3, 2026, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- IZQ
- Device class
- 2
- Regulation
- 870.1650
- Medical specialty
- Cardiovascular
Makers by country
| Country | Makers |
|---|---|
| Germany | 6 |
| United States | 6 |
| Mexico | 2 |
| Italy | 2 |
| Switzerland | 1 |
| Australia | 1 |
| Costa Rica | 1 |
| Morocco | 1 |
| Ireland | 1 |
| Tunisia | 1 |
| Monaco | 1 |
| China | 1 |
Makers of Injector, Contrast Medium, Automatic
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Ulrich GMBH & Co. KG | ULM Baden-Wurttemberg, Germany | Manufacturer | 7 | November 18, 2025 | 0 | 0 | 0 | api.fda.gov |
| 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 |
| Bracco Injeneering S.A. | LAUSANNE Vaud, Switzerland | Manufacturer, Specification developer | 2 | April 13, 2007 | 0 | 0 | 0 | api.fda.gov |
| Imaxeon Pty Ltd | Rydalmere New South Wales, Australia | Specification developer | 2 | September 24, 2025 | 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 |
| Ulrich GMBH & Co. KG | Dornstadt Baden-Wurttemberg, Germany | Manufacturer | 2 | November 18, 2025 | 0 | 0 | 0 | api.fda.gov |
| Bytec Medizintechnik GMBH | Eschweiler North Rhine-Westphalia, Germany | Contract manufacturer | 0 | 0 | 0 | 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 | |
| Bayer Medical SRL | Barreal de Heredia, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Border Assembly S de RL de CV | TIJUANA Baja California, Mexico | Contract 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 | |
| Emotechnic | Casablanca, Morocco | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gerresheimer Regensburg GmbH | Wackersdorf Bavaria, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ICU Medical Healthcare Manufacturing S.A. de C.V. | APODACA Nuevo Leon, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Infumed GMBH | Friedeburg Lower Saxony, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lre Medical GMBH | NOERDLINGEN Bavaria, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medisize Ireland Ltd. | LETTERKENNY Donegal, Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Promedtech | Fouchena Tunis, Tunisia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Promepla S.A.M | MONACO Monaco-Ville, Monaco | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sidam SRL | Mirandola Modena, Italy | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sidam SRL | Mirandola Modena, Italy | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vincent Medical (dong Guan) Manufacturing Co., Ltd. | Dong Guan City Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 3, 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.