Company · US
Bayer Medical Care, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2015 to 2026. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (3 in 12 months)
10recalls (2 in 12 months)
10recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 6, 2026 | K262043 | MEDRAD® MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD® IS12 Module (IS12); MEDRAD® Imaging B Bayer Medical Care, Inc. | DXT |
| Jun 12, 2026 | K253688 | MEDRAD® Imaging Bulk Package Transfer Spike Bayer Medical Care, Inc. | PQH |
| Feb 13, 2026 | K252891 | MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2) Bayer Medical Care, Inc. | DXT |
| Sep 4, 2025 | K250893 | Ball Joint Guide Array (66295) Bayer Medical Care, Inc. | HAW |
| Jul 30, 2020 | K200280 | MEDRAD Imaging Bulk Package Transfer Spike Bayer Medical Care, Inc. | PQH |
| Dec 13, 2019 | K192370 | MEDRAD Stellant FLEX CT Injection System with Certegra Workstation Bayer Medical Care, Inc. | DXT |
| Dec 5, 2019 | K193028 | MEDRAD Mark 7 Arterion Injection System Bayer Medical Care, Inc. | DXT |
| Nov 1, 2018 | K182276 | MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit Bayer Medical Care, Inc. | DXT |
| Nov 1, 2018 | K182273 | MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant C Bayer Medical Care, Inc. | DXT |
| Aug 17, 2018 | K173773 | MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant C Bayer Medical Care, Inc. | DXT |
| Aug 14, 2015 | K143538 | MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit Bayer Medical Care, Inc. | DXT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2026 | Bayer Medical Care, Inc. MEDRAD Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System;
Catalog number: FLEXS-150-QFT; Open, Classified |
DXT | K182273 |
| Jun 3, 2026 | Bayer Medical Care, Inc. Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with the Medrad Avanta Injection System;
Catalog number: AVA 500 MPAT (Part 2 of 2);
Affected material numbers: 87629007 Open, Classified |
DXT | K050456 |
| Jan 6, 2023 | Bayer Medical Care, Inc. Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile
Catalog number: INT CSS
Affected material number: 86566621
Intended to deliver accurate doses of 18F Fluorode Open, Classified |
FRN | K100798 |
| Sep 14, 2021 | Bayer Medical Care, Inc. The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube is a syringe made from a clear polycarbonate material and is an accessory to the MEDRAD Mark 7 Arterion Injection System. It is des Terminated |
DXT | K132928 |
| Oct 5, 2020 | Bayer Medical Care, Inc. Brand Name: MEDRAD Stellant FLEX Syringe Kits
Common Name: Angiographic Syringe
Catalog/REF Number: FLEXD-150-SCS
Description: 2 - 150 mL FLEX syringes, 1 large saline spike, 1 small contrast spike Terminated |
DXT | K192370 |
| Dec 14, 2018 | Bayer Medical Care, Inc. MAVIG Portegra or Portegra2 Overhead Counterpoise System (OCS) used in conjunction with the Medrad Stellant CT Injection System (Certegra Workstation), Medrad Mark 7 Arterion" Injection System, or Med Terminated |
DXT | K023183 K112086 +2 |
| Sep 7, 2018 | Bayer Medical Care, Inc. Codan Filter (Codan catalog number BC 693) used with Medrad Patient Administration Sets (PAS) and Intego PET Infusion Systems
Product Usage:
1.2 micron filter for use with Intravenous Administration Terminated |
FPA | K830755 |
| Jun 28, 2018 | Bayer Medical Care, Inc. Overhead Counterpoise Systems (OCS), OCS, 580mm CEILING MOUNT, PORTEGRA2, Catalog # OCS CEIL 58, Material Number 84433765 Terminated |
JAK | K934206 |
| Jun 28, 2018 | Bayer Medical Care, Inc. Overhead Counterpoise Systems (OCS), OCS CONF,STD CEIL MNT, STD HORZ ARM, Catalog # OCS 115A, Material Number 59880253 Terminated |
JAK | K944983 |
| Jun 28, 2018 | Bayer Medical Care, Inc. Overhead Counterpoise Systems (OCS) OCS CONF an accessory device for use with Bayer injector systems as a support for an injector head. , SHORT CEIL MNT, STD HORZ ARM, Catalog # OCS 115AS, Material N Terminated |
JAK | K944983 |