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Date Title:
13.05.2025 Urgent Field Safety Notice for Olympic Brainz Monitor by Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 17640/25

13.05.2025 Urgent Field Safety Notice for Microstream Advance and Microstream Luer Sampling Lines by Covidien llc

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 06179/25

12.05.2025 Urgent Field Safety Notice for Tempus Pro by Remote Diagnostic Techologies Ltd

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 15975/25

12.05.2025 Urgent Field Safety Notice for Silverline Ventrikelsonde mit Schädelschraube by Spiegelberg GmbH & Co. KG

Product group Non-active implants - special implants
Reference 15613/25

12.05.2025 CHMP Meeting Highlights April 2025

CHMP Meeting Highlights April 2025
12.05.2025 CHMP Committee for Medicinal Products for Human Use

CHMP Meeting Highlights for May 2025
09.05.2025 Urgent Field Safety Notice for Meona, die elektronische Kurve by Mesalvo Freiburg GmbH

Product group Medical data processing (software) - others
Reference 12455/25

09.05.2025 Urgent Field Safety Notice for BX2 Needle Guide by CIVCO Medical Instruments CO

Product group Medical instruments for use in humans - cardiac/thorax surgery
Reference 17826/25

09.05.2025 Urgent Field Safety Notice for ORTHO Vision & Vision Max Analyzer by Ortho Clinical Diagnostics Inc.

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 16900/25

09.05.2025 Urgent Field Safety Notice for DxI 9000 Access Immunoassay Analyzer by Beckman Coulter Inc.

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 18462/25

09.05.2025 Urgent Field Safety Notice for Catalyst, Catalyst+ by C-RAD Positioning AB

Product group Radiological technology - navigation systems
Reference 16785/25

09.05.2025 Urgent Field Safety Notice for DxI 9000 Access Immunoassay Analyzer by Beckman Coulter Inc.

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 18201/25

09.05.2025 Urgent Field Safety Notice for Merlin Assay (incl. software, M.A.) by SkylineDx B.V.

Product group In-vitro diagnostics - immunological products
Reference 17085/25

09.05.2025 Urgent Field Safety Notice for CarpoFit monoblock broach by implantcast GmbH

Product group Medical instruments for use in humans - bone surgery
Reference 18756/25

09.05.2025 CHMP Meeting Highlights March 2025

CHMP Meeting Highlights March 2025
08.05.2025 Finasteride- and dutasteride-containing medicines: suicidal thoughts and behaviours

Active substance: finasteride, Dutasteride EMA’s safety committee, PRAC has confirmed suicidal ideation as a side effect of finasteride 1 and 5 mg tablets.

08.05.2025 Urgent Field Safety Notice for ENDOPATH ECHELONT Vascular White Reload by Ethicon Endo-Surgery, LLC.

Product group Medical instruments for use in humans - general instruments
Reference 16006/25

08.05.2025 Urgent Field Safety Notice for Check-Flo Performer Introducer by Cook Incorporated

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 15050/25

07.05.2025 Urgent Field Safety Notice for CADD-Solis Ambulatory Infusion Pump by Smiths Medical ASD, Inc.

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 18163/25

07.05.2025 Urgent Field Safety Notice for CADD-Solis Ambulatory Infusion Pump by Smiths Medical ASD, Inc.

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 18164/25