6 results
·
12ms
·
Sources: EU EUDAMED, US FDA
Horizon Cardiology Hemo. Version 12.2.
FDA Enforcement
Class II
·Ongoing·CHANGE HEALTHCARE CANADA COMPANY·October 23, 2024
Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product Description: Laparoscopic Insufflator
FDA Enforcement
Class II
·Ongoing·Canadian Hospital Specialties Ltd.·July 24, 2024
McKesson Cardiology Hemo. Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0.
FDA Enforcement
Class II
·Ongoing·CHANGE HEALTHCARE CANADA COMPANY·October 23, 2024
NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468
FDA Enforcement
Class II
·Ongoing·Luminex Molecular Diagnostics Inc·October 16, 2024
Change Healthcare Cardiology Hemo. Versions 14.2, 14.1.1, 14.2, 14.3, 14.3.2, 14.3, 15.0.1, 15.1.
FDA Enforcement
Class II
·Ongoing·CHANGE HEALTHCARE CANADA COMPANY·October 23, 2024
NxTAG Respiratory Pathogen Panel, REF: I051C0447
FDA Enforcement
Class II
·Ongoing·Luminex Molecular Diagnostics Inc·October 16, 2024