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Bayer Medical Care, Inc.

FDA 510(k) & PMA Approved Devices — 9 products

Total Devices9
Categories3
Latest FDA decision2026-06-12
TypeNumberDevice NameCodeDateActions
510(k) K253688 MEDRAD® Imaging Bulk Package Transfer SpikePQH2026-06-12 View
510(k) K252891 MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)DXT2026-02-13 View
510(k) K250893 Ball Joint Guide Array (66295)HAW2025-09-04 View
510(k) K200280 MEDRAD Imaging Bulk Package Transfer SpikePQH2020-07-30 View
510(k) K192370 MEDRAD Stellant FLEX CT Injection System with Certegra WorkstationDXT2019-12-13 View
510(k) K193028 MEDRAD Mark 7 Arterion Injection SystemDXT2019-12-05 View
510(k) K182276 MEDRAD MRXperion MR Injection System and MR Injection System Syringe KitDXT2018-11-01 View
510(k) 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.CTDXT2018-11-01 View
510(k) 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.CTDXT2018-08-17 View
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