Data / Medical devices / United States / Bayer Medical Care Inc.
Bayer Medical Care Inc.: FDA-registered device maker in Saxonburg, PA, United States, 4 510(k) clearances
Bayer Medical Care Inc. is registered with the FDA (registration 3006791331) in Saxonburg, PA, United States. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated November 1, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006791331
- Address
- 150 Victory Road, Saxonburg, PA, United States, 16056
- Owner or operator
- Bayer Medical Care Inc. (2520313)
- Roles
- Manufacturer
- First device listed
- August 20, 1992
- Registered through
- 2026
- Brand names listed
- Connect.CT, ISI, Imaging System Interface - ISI2 Module, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Connector Tubing, MEDRAD Stellant Dual Syringe Quad-Pak with a Large Saline Spike and a Small Contrast Spike (SDS-CTP-SCS), MEDRAD Stellant FLEX 150 mL Sterile Disposable Syringe with Spike (FLEXS-150-SPK), MEDRAD Stellant FLEX CT Injection System with Certegra Workstation and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Injector And Syringe, Angiographic | DXT | 2 | Manufacturer | accessdata.fda.gov |
| Injector, Contrast Medium, Automatic | IZQ | 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 |
|---|---|---|---|---|---|---|
| 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 |
| January 12, 2009 | K082905 | MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC | 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 |
Compare with other makers
Updated November 1, 2018. 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.