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Date Title:
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

07.05.2025 Urgent Field Safety Notice for Atellica IM Homocysteine Calibrator (Kit), ADVIA Centaur HCY Calibrator (Kit) by Siemens Healthcare Diagnostics Inc. Tarrytown

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 16065/25

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 18165/25

07.05.2025 Urgent Field Safety Notice for REAL by Mercado Medic AB

Product group Orthopaedic / Rehabilitation technology - daily living aids
Reference 17057/25

06.05.2025 Urgent Field Safety Notice for Leica Biosystems Tissue processor (HistoCore Pegasus/Plus) by Leica Biosystems Nussloch GmbH

Product group In-vitro diagnostics - instruments, apparatuses and systems
Reference 12056/24

06.05.2025 Urgent Field Safety Notice for Creatinine by Beckman Coulter Inc.

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 17465/25

05.05.2025 Urgent Field Safety Notice for B. subtilis Hemmstoffplatte MiQ by Axon Biotech GmbH

Product group In-vitro diagnostics - microbiological products
Reference 17517/25