Data / Medical devices / United States / Bayer Medical Care Inc.

Bayer Medical Care Inc.: FDA-registered device maker in Pittsburgh, PA, United States, 17 510(k) clearances

Name: Bayer Medical Care Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Bayer Medical Care Inc. is registered with the FDA (registration 3004056159) in Pittsburgh, PA, United States. It lists 5 device types. The FDA files 17 510(k) clearances under its listings, the newest dated February 13, 2026. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3004056159
Address: 625 Alpha Dr, Pittsburgh, PA, United States, 15238
Owner or operator: Bayer Medical Care Inc. (2520313)
Roles: Contract manufacturer, Manufacturer, Manufacturer for export, Remanufacturer
First device listed: August 20, 1992
Registered through: 2026
Brand names listed: Centargo CT Injection Systems, Connect.CT, ISI, Imaging System Interface - ISI2 Module, MEDRAD Centargo CT Injection System, MEDRAD Centargo Day Set, MEDRAD Centargo Patient Line, MEDRAD Centargo Replacement Spike and more

Devices it lists

Device	Product code	Class	Role	Source
Injector And Syringe, Angiographic	DXT	2	Contract manufacturer, Manufacturer, Remanufacturer	accessdata.fda.gov
Injector, Contrast Medium, Automatic	IZQ	2	Contract manufacturer, Manufacturer, Manufacturer for export, Remanufacturer	accessdata.fda.gov
Medical Device Data System	OUG	1	Manufacturer	accessdata.fda.gov
Pump, Infusion	FRN	2	Manufacturer	accessdata.fda.gov
System, X-Ray, Tomography, Computed	JAK	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
February 13, 2026	K252891	MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)	DXT	Substantially Equivalent	Bayer Medical Care, Inc.	accessdata.fda.gov
November 1, 2018	K182276	MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit	DXT	Substantially Equivalent	Bayer Medical Care, Inc.	accessdata.fda.gov
November 1, 2018	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	Substantially Equivalent	Bayer Medical Care, Inc.	accessdata.fda.gov
August 17, 2018	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	Substantially Equivalent	Bayer Medical Care, Inc.	accessdata.fda.gov
August 14, 2015	K143538	MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit	DXT	Substantially Equivalent	Bayer Medical Care, Inc.	accessdata.fda.gov
January 23, 2014	K132928	MEDRAD MARK 7 ARTERION INJECTION SYSTEM / SYRINGE, TWIST & GO SYRINGE	DXT	Substantially Equivalent	Medrad, Inc. / Bayer Medical Care, Inc.	accessdata.fda.gov
December 15, 2011	K113133	MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGE	DXT	Substantially Equivalent	Medrad, Inc.	accessdata.fda.gov
October 14, 2011	K112086	MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION SYRINGE	DXT	Substantially Equivalent	Medrad, Inc.	accessdata.fda.gov
June 23, 2010	K100798	MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRATIN SET MODEL INT SYS 100, INT CSS, INT C	FRN	Substantially Equivalent	Medrad, Inc.	accessdata.fda.gov
January 12, 2009	K082905	MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC	DXT	Substantially Equivalent	Medrad, Inc.	accessdata.fda.gov
October 17, 2008	K082458	P3T ABDOMEN	JAK	Substantially Equivalent	Medrad, Inc.	accessdata.fda.gov
June 17, 2008	K080297	MEDRAD INTEGO PET INFUSION SYSTEM	FRN	Substantially Equivalent	Medrad, Inc.	accessdata.fda.gov
December 21, 2007	K072886	MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T	DXT	Substantially Equivalent	Medrad, Inc.	accessdata.fda.gov
June 17, 2005	K050456	MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM	DXT	Substantially Equivalent	Medrad, Inc.	accessdata.fda.gov
December 10, 2004	K042784	MEDRAD SPECTRIS SOLARIS EP MR INJECTOR SYSTEM	DXT	Substantially Equivalent	Medrad, Inc.	accessdata.fda.gov
January 10, 2003	K023183	MEDRAD STELLANT CT INJECTOR SYSTEM	DXT	Substantially Equivalent	Medrad, Inc.	accessdata.fda.gov
September 28, 1982	K822536	MARK V	DXT	Substantially Equivalent	Medrad, Inc.	accessdata.fda.gov

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Updated February 13, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.