Medical Device Manufacturer · US , Indianola , PA

Bayer Medical Care, Inc. - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 2015

9

Total

9

Cleared

0

Denied

FDA 510(k) Regulatory Record - Bayer Medical Care, Inc. Cardiovascular ✕

4 devices

1-4 of 4

Cleared Nov 01, 2018

MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD...

Cardiovascular · 71d

Cleared Nov 01, 2018

MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit

Cardiovascular · 71d

Cleared Aug 17, 2018

MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD...

Cardiovascular · 248d

Cleared Aug 14, 2015

MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit

Cardiovascular · 242d