Bayer Medical Care, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Bayer Medical Care, Inc. - FDA 510(k) Cleared Devices
Recent clearances: MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit, Ball Joint Guide Array (66295), MEDRAD Imaging Bulk Package Transfer Spike
10
Total
10
Cleared
0
Denied
Bayer Medical Care, Inc. has 10 FDA 510(k) cleared medical devices. Based in Indianola, US.
Latest FDA clearance: Jun 2026. Active since 2015. Primary specialty: General Hospital.
Browse the FDA 510(k) cleared devices submitted by Bayer Medical Care, Inc. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Bayer Medical Care, Inc.
10 devices
Cleared
Jun 12, 2026
MEDRAD® Imaging Bulk Package Transfer Spike
General Hospital
203d
Cleared
Feb 13, 2026
MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit
General Hospital
155d
Cleared
Sep 04, 2025
Ball Joint Guide Array (66295)
Neurology
163d
Cleared
Jul 30, 2020
MEDRAD Imaging Bulk Package Transfer Spike
General Hospital
177d
Cleared
Dec 13, 2019
MEDRAD Stellant FLEX CT Injection System with Certegra Workstation
General Hospital
105d
Cleared
Dec 05, 2019
MEDRAD Mark 7 Arterion Injection System
General Hospital
36d
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