All news at a glance
| Date | Title: |
|---|---|
| 07.10.2025 |
Urgent Field Safety Notice for CRP FS by DiaSys Diagnostic Systems GmbH
Product group In-vitro diagnostics -
immunological products
|
| 07.10.2025 |
Urgent Field Safety Notice for Signia Small Diameter Curved Tip Intelligent Reloads by Covidien llc
Product group Medical instruments for use in humans -
general instruments
|
| 07.10.2025 |
Urgent Field Safety Notice for MEDAP TWISTA S. 1070, MEDAP BORA UP 2080, MEDAP VENTA S. 26 N, ATMOS Varioair 3 by ATMOS MedizinTechnik GmbH & Co. KG
Product group Surgical equipment/ Anaesthesia -
surgical equipment
|
| 07.10.2025 |
Urgent Field Safety Notice for Eschweiler combiline/Eschweiler modularPro by Eschweiler GmbH & Co. KG
Product group In-vitro diagnostics -
haematological, histological and cytological products
|
| 07.10.2025 |
Urgent Field Safety Notice for DxI 9000 Access Immunoassay Analyzer, DxC 500i by Beckman Coulter, Inc.
Product group In-vitro diagnostics -
equipment / products for clinical chemistry
|
| 07.10.2025 |
Urgent Field Safety Notice for UniCel DxH 900 COULTER Cellular Analysis System UniCel DxH 690T COULTER Cellular Analysis System UniCel DxH 800 COULTER Cellular Analysis System* UniCel DxH 600 COULTER Cellular Analysis System* FRU,LED HGB PHOTOMETER by Beckman Coulter Biotechnology (Suzhou) Co.,Ltd.
Product group In-vitro diagnostics -
haematological, histological and cytological products
|
| 07.10.2025 |
Urgent Field Safety Notice for VITUS-Fi Distal Fibula Nail Ø 3.6mm, L 145mm by Dieter Marquardt-Medizintechnik GmbH
Product group Non-active implants -
bone surgery
|
| 07.10.2025 |
Urgent Field Safety Notice for IMMULITE/ IMMULITE 1000 Intact PTH; IMMULITE 2000 Intact PTH by Siemens Healthcare Diagnostics Products Ltd.
Product group In-vitro diagnostics -
immunological products
|
| 06.10.2025 |
Urgent Field Safety Notice for MAC VU360 by GE Medical Systems Information Technologies, Inc.
Product group Medical electronics / Electromedical devices -
electrodiagnostics
|
| 02.10.2025 | eSubmission |
| 02.10.2025 | New validation criteria for eCTD submissions - mandatory after 1 December 2025 |
| 02.10.2025 |
Urgent Field Safety Notice for IntelliSpace Cardiovascular ISCV by Philips Healthcare
Product group Radiological technology -
auxiliary equipment and supplies for radiology / nuclear medicine
|
| 02.10.2025 |
Urgent Field Safety Notice for Biosteon Screw by Biocomposites Ltd.
Product group Non-active implants -
bone surgery
|
| 02.10.2025 |
Urgent Field Safety Notice for CompoFlow Inlinesystem by Fresenius Kabi Deutschland GmbH
Product group Injections / Infusions / Transfusions / Dialysis -
equipment for collecting blood products and peripheral stem cells
|
| 02.10.2025 |
Urgent Field Safety Notice for Alinity hq Analyzer by Abbott GmbH
Product group In-vitro diagnostics -
haematological, histological and cytological products
|
| 02.10.2025 |
Urgent Field Safety Notice for suPARnostic TurbiLatex Reagents by ViroGates A/S
Product group In-vitro diagnostics -
haematological, histological and cytological products
|
| 02.10.2025 |
Urgent Field Safety Notice for Natura+ by ConvaTec Limited Deeside
Product group Orthopaedic / Rehabilitation technology -
care of natural and artificial body orifices
|
| 02.10.2025 |
Urgent Field Safety Notice for ERYTRA by Diagnostic Grifols SA
Product group In-vitro diagnostics -
haematological, histological and cytological products
|
| 02.10.2025 |
Urgent Field Safety Notice for LIFECODES PakPlus by immucor GTI Diagnostics, Inc.
Product group In-vitro diagnostics -
haematological, histological and cytological products
|
| 02.10.2025 |
Urgent Field Safety Notice for ULTRAVIT Vitrectomy and HYPERVIT Vitrectomy Probes by Alcon Laboratories, Inc.
Product group ophthalmological technology -
equipment for ophthalmological therapeutics
|