Medical Device Manufacturer · US , Indianola , PA

Bayer Medical Care, Inc.

9 submissions · 9 cleared · Since 2015
9
Total
9
Cleared
0
Denied

Bayer Medical Care, Inc. — FDA 510(k) Submissions

Bayer Medical Care, Inc. has submitted 9 FDA 510(k) premarket notifications since 2015, of which 9 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Injector And Syringe, Angiographic, Iodinated Contrast Media Transfer Tubing Set, Neurological Stereotaxic Instrument . Use the specialty filter in the sidebar to narrow results.

9 devices
1–9 of 9
MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)
K252891 · DXT Injector And Syringe,... · General Hospital
Feb 2026 155d
Ball Joint Guide Array (66295)
K250893 · HAW Neurological Stereotaxic... · Neurology
Sep 2025 163d
MEDRAD Imaging Bulk Package Transfer Spike
K200280 · PQH Iodinated Contrast Media... · General Hospital
Jul 2020 177d
MEDRAD Stellant FLEX CT Injection System with Certegra Workstation
K192370 · DXT Injector And Syringe,... · General Hospital
Dec 2019 105d
MEDRAD Mark 7 Arterion Injection System
K193028 · DXT Injector And Syringe,... · General Hospital
Dec 2019 36d
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
K182273 · DXT Injector And Syringe,... · Cardiovascular
Nov 2018 71d
MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit
K182276 · DXT Injector And Syringe,... · Cardiovascular
Nov 2018 71d
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
K173773 · DXT Injector And Syringe,... · Cardiovascular
Aug 2018 248d
MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit
K143538 · DXT Injector And Syringe,... · Cardiovascular
Aug 2015 242d
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