Bayer Medical Care, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 8
- 510(k) Clearances
- 9
- Inspections
- 13
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0910-2023 | Class II | Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile Catalog nu | November 30, 2022 |
| Z-0199-2022 | Class II | The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube is a syringe made from a clear | September 14, 2021 |
| Z-0483-2021 | Class II | Brand Name: MEDRAD Stellant FLEX Syringe Kits Common Name: Angiographic Syringe Catalog/REF Nu | October 5, 2020 |
| Z-0745-2019 | Class II | MAVIG Portegra or Portegra2 Overhead Counterpoise System (OCS) used in conjunction with the Medrad S | December 14, 2018 |
| Z-0097-2019 | Class II | Codan Filter (Codan catalog number BC 693) used with Medrad Patient Administration Sets (PAS) and In | September 7, 2018 |
| Z-2961-2018 | Class II | Overhead Counterpoise Systems (OCS) OCS CONF an accessory device for use with Bayer injector systems | June 28, 2018 |
| Z-2960-2018 | Class II | Overhead Counterpoise Systems (OCS), OCS CONF,STD CEIL MNT, STD HORZ ARM, Catalog # OCS 115A, Materi | June 28, 2018 |
| Z-2962-2018 | Class II | Overhead Counterpoise Systems (OCS), OCS, 580mm CEILING MOUNT, PORTEGRA2, Catalog # OCS CEIL 58, Mat | June 28, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K252891 | MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2) | February 13, 2026 |
| K250893 | Ball Joint Guide Array (66295) | September 4, 2025 |
| K200280 | MEDRAD Imaging Bulk Package Transfer Spike | July 30, 2020 |
| K192370 | MEDRAD Stellant FLEX CT Injection System with Certegra Workstation | December 13, 2019 |
| K193028 | MEDRAD Mark 7 Arterion Injection System | December 5, 2019 |
| K182273 | MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kit | November 1, 2018 |
| K182276 | MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit | November 1, 2018 |
| K173773 | MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kit | August 17, 2018 |
| K143538 | MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit | August 14, 2015 |