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14.06.2024 Statistical requirements for applications for authorisation of a clinical trial with medical devices

The BfArM has summarised the requirements for statistics in clinical trials with medical devices in a guideline.
14.06.2024 Urgent Field Safety Notice for IH-1000 Analyzer by Bio-Rad Laboratories, DiaMed GmbH

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 02445/23

14.06.2024 Urgent Field Safety Notice for Bivona Neonatal/Pediatric and Adult Tracheostomy Tube by Smiths Medical ASD, lnc.

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 18552/24

14.06.2024 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 16954/24

14.06.2024 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 17126/24

14.06.2024 Urgent Field Safety Notice for Ascenda Intrathecal Catheter by Medtronic Inc

Product group Active implantable medical devices - drug pumps
Reference 15426/24

14.06.2024 Urgent Field Safety Notice for Afinion 2 by Abbott Diagnostics Technologies AS

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 16865/24

14.06.2024 Urgent Field Safety Notice for Hintermann Series H3 Total Ankle Replacement System by DT MedTech LLC

Product group Non-active implants - bone surgery
Reference 09281/24

13.06.2024 Urgent Field Safety Notice for NexGen CR-Flex porous or NexGen CR-Flex Fiber Metal Mesh Femur by Zimmer Inc.

Product group Non-active implants - bone surgery
Reference 11841/24

13.06.2024 Urgent Field Safety Notice for Connecting Tubes by Extrudan S.. z o.o Zakrzewo

Product group Injections / Infusions / Transfusions / Dialysis - drainages and suction systems
Reference 16775/24

13.06.2024 Urgent Field Safety Notice for RAL Diff-Quik Fixative solution by RAL DIAGNOSTICS

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 16310/24

13.06.2024 Urgent Field Safety Notice for CardioLab, ComboLab by GE Medical Systems Information Technologies, Inc.

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 16014/24

13.06.2024 Urgent Field Safety Notice for Height Adjustable (HA) FlexTrak Trolley by Philips Medical Systems Nederland B.V.

Product group Electromedical fields - equipment for MR tomography
Reference 15021/24

13.06.2024 Urgent Field Safety Notice for DeepUnity Diagnost by DH Healthcare GmbH

Product group Radiological technology - auxiliary equipment and supplies for radiology / nuclear medicine
Reference 18027/24

12.06.2024 Urgent Field Safety Notice for Proclaim, Infinity by Abbott - Neuromodulation Division

Product group Active implantable medical devices - biostimulators
Reference 18134/24

12.06.2024 Urgent Field Safety Notice for Proclaim, Infinity by Abbott - Neuromodulation Division

Product group Active implantable medical devices - biostimulators
Reference 18136/24

11.06.2024 Urgent Field Safety Notice for LumiraDx Platform Instrument V5E by LumiraDx UK Ltd

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 16661/24

11.06.2024 Urgent Field Safety Notice for Endo-Model-M & Endo-Model SL (Tibial components) by Waldemar Link GmbH & Co. KG

Product group Non-active implants - bone surgery
Reference 16269/24

11.06.2024 CHMP Committee for Medicinal Products for Human Use

CHMP Meeting Highlights for May 2024
11.06.2024 Urgent Field Safety Notice for BeneHeart D1 Defibrilator/Monitor by SHENZSHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 16854/24