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12.05.2025
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Urgent Field Safety Notice for Tempus Pro by Remote Diagnostic Techologies Ltd
Product group Medical electronics / Electromedical devices -
electrodiagnostics
Reference 15975/25
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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
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12.05.2025
|
Structure of the BfArM
Structure
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12.05.2025
|
CHMP Meeting Highlights April 2025
CHMP Meeting Highlights April 2025
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12.05.2025
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CHMP Committee for Medicinal Products for Human Use
CHMP Meeting Highlights for April 2025
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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
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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
|
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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
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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
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09.05.2025
|
Urgent Field Safety Notice for Catalyst, Catalyst+ by C-RAD Positioning AB
Product group Radiological technology -
navigation systems
Reference 16785/25
|
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09.05.2025
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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
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|
09.05.2025
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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
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|
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.
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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
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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
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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
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|
07.05.2025
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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
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