Bayer Medical Care, Inc.
FDA 510(k) & PMA Approved Devices — 8 products
Total Devices8
Categories3
Latest Approval2026-02-13
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K252891 | MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2) | DXT | 2026-02-13 | View |
| 510(k) | K250893 | Ball Joint Guide Array (66295) | HAW | 2025-09-04 | View |
| 510(k) | K200280 | MEDRAD Imaging Bulk Package Transfer Spike | PQH | 2020-07-30 | View |
| 510(k) | K192370 | MEDRAD Stellant FLEX CT Injection System with Certegra Workstation | DXT | 2019-12-13 | View |
| 510(k) | K193028 | MEDRAD Mark 7 Arterion Injection System | DXT | 2019-12-05 | View |
| 510(k) | K182276 | MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit | DXT | 2018-11-01 | View |
| 510(k) | K182273 | MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT | DXT | 2018-11-01 | View |
| 510(k) | K173773 | MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT | DXT | 2018-08-17 | View |
No matching devices.