Panels › Cardiovascular › Product code IZQ · Class 2
Injector, Contrast Medium, Automatic
Regulation 870.1650
3510(k)s in 12 months (23 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in IZQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Ulrich GmbH & Co. KG | 7 | 0 |
| Mallinckrodt Inc | 0 | 3 |
| ACIST Medical Systems, Inc. | 2 | 0 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 2 | 0 |
| E-Z-Em, Inc. | 2 | 0 |
| Imaxeon Pty, Ltd. | 2 | 0 |
| Bracco Injeneering | 1 | 0 |
| Kenex , Ltd. | 1 | 0 |
| Liebel-Flarsheim Company, LLC | 1 | 0 |
| Mallinckrodt Inc., Liebel-Flarsheim Business | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 20, 2012 | Mallinckrodt Inc Illumena 150mL Linden Luer Syringe with Handi-Fil Straw (p/n 900103) & Illumena 150mL Regular Luer Syringe with Handi-Fil (p/n 900101), Made in Mexico, Liebel-Flarsheim Company, Cincinnati, OH
The Li Terminated |
IZQ | K781334 |
| Jul 21, 2011 | Mallinckrodt Inc Angiomat Illumena Syringe, 150mL Linden Luer Syringe with Handi-Fil Straw (p/n 900103), in a sealed molded plastic tray.
The Liebel Flarsheim Illumena 150 mL Linden Luer Syringe with Handi-Fil Straw Terminated |
IZQ | K963071 |
| Aug 15, 2008 | Mallinckrodt Inc The OptiVantage DH Injection System is a contrast delivery system and is designed to inject radiopaque contrast media into a patient's vascular system to obtain diagnostic images when used with comput Terminated |
IZQ | K063503 |
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