Device type
Injector And Syringe, Angiographic
Product code DXT · Class II · 21 CFR 870.1650 · Cardiovascular
Recent 510(k)s
Oct 6, 2026
K262043
MEDRAD® MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD® IS12 Module (IS12); MEDRAD® Imaging Bulk Package Transfer Spike
Bayer Medical Care, Inc.
- DXT
- Class II
Recent recalls
Sep 23, 2026
Z-3147-2026
MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT;
Bayer Medical Care, Inc.
- DXT
- Class II
- Ongoing