Arca
Skip to content

Bayer

Pharmaceutical companyAI in United StatesAI. FDA records under 3 spellings of its name, each linked to the record. See the Bayer group view.

  • Records across the group: 964, 29 entitiesAI
  • 510(k) clearances: 724
  • Drug applications: 164
  • Device recalls: 37
  • Drug recalls: 35

Records by Year

Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Bayer and its 28 subsidiaries

Latest Records

Newest first across sources; each opens the record
DateRecordSource
Oct 6, 2026MEDRAD® MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD® IS12 Module (IS12); MEDRAD® Imaging Bulk Package Transfer SpikeK262043 · DXT510(k) clearances
Jul 31, 2026Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose Vial, Rx only, Sterile SoClass I · Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.Drug recalls
Jun 12, 2026MEDRAD® Imaging Bulk Package Transfer SpikeK253688 · PQH510(k) clearances
Apr 28, 2026Untitled letter: NUBEQAOffice of Prescription Drug PromotionOPDP letters
Feb 13, 2026MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)K252891 · DXT510(k) clearances
Oct 17, 2025Warning letter: Sterility assurance, Cleaning validation, Out-of-specificationCDERWarning letters
Sep 4, 2025Ball Joint Guide Array (66295)K250893 · HAW510(k) clearances
Jun 13, 2024Complete response letter, NDA 218506UnapprovedComplete response letters
Nov 18, 2020Liebel-Flarsheim IBP Transfer SetK193010 · PQH510(k) clearances
Jul 30, 2020MEDRAD Imaging Bulk Package Transfer SpikeK200280 · PQH510(k) clearances
Dec 13, 2019MEDRAD Stellant FLEX CT Injection System with Certegra WorkstationK192370 · DXT510(k) clearances
Dec 5, 2019MEDRAD Mark 7 Arterion Injection SystemK193028 · DXT510(k) clearances
Nov 14, 2017Warning letter: Data integrity, Cleaning validation, Process validationCDERWarning letters
Nov 21, 2013Medrad Veris MR Monitor units The system is intended to monitor physiological parameters of patients within any healthcare environment. Class II · The main board, P/N 301641, installed in some Medrad Veris MR Monitor units may be faulty and could lead to unexpected sDevice recalls

Subsidiaries and Divisions

28 firms in the Bayer group, most records first

Canada and Imports

Across the Bayer group, matched by company name
Active Health Canada device licences
16, as of Nov 10, 2026
FDA import refusals since 2024
85 shipment lines, through Oct 23, 2026

Names and Identifiers

Appears as
Bayer Corp.BAYERBayer Corp
FEI numbers in warning letters
30028064621028892
Website
bayer.com

Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built

Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.