FDA 510(k) Applications Submitted by BAYER MEDICAL CARE INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K182276 |
08/22/2018 |
MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit |
Bayer Medical Care Inc. |
| K193028 |
10/30/2019 |
MEDRAD Mark 7 Arterion Injection System |
Bayer Medical Care Inc. |
| K200280 |
02/04/2020 |
MEDRAD Imaging Bulk Package Transfer Spike |
Bayer Medical Care Inc. |
| K173773 |
12/12/2017 |
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 |
Bayer Medical Care Inc. |
| K182273 |
08/22/2018 |
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 |
Bayer Medical Care Inc. |
| K143538 |
12/15/2014 |
MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit |
BAYER MEDICAL CARE INC. |
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