All news at a glance
| Date | Title: |
|---|---|
| 24.09.2025 |
Urgent Field Safety Notice for t:slim X2 Insulin Pump by Tandem Diabetes Care, Inc
Product group Injections / Infusions / Transfusions / Dialysis -
infusion technology
|
| 26.09.2025 |
Urgent Field Safety Notice for CODMAN Disposable Perforator (Codman Einmalbohrer) by Integra LifeSciences Corp.
Product group Medical instruments for use in humans -
bone surgery
|
| 26.09.2025 |
Urgent Field Safety Notice for HOTLINE Fluid Warmer by Smiths Medical ASD, lnc.
Product group Injections / Infusions / Transfusions / Dialysis -
equipment for collecting blood products and peripheral stem cells
|
| 29.09.2025 | TOPRA Symposium 2025 |
| 29.09.2025 |
Urgent Field Safety Notice for Medistim MiraQ Systems by Medistim ASA
Product group Ultrasonics -
ultrasonic diagnostic equipment
|
| 30.09.2025 |
Urgent Field Safety Notice for Carescape Central Station by GE Medical Systems Information Technologies, Inc.
Product group Medical electronics / Electromedical devices -
electrodiagnostics
|
| 01.10.2025 | Comments concerning texts published in Issue 12.2 |
| 01.10.2025 |
Urgent Field Safety Notice for Dragonfly, Phantom by Metrex Research, LLC dba Orascoptic
Product group Dental products -
others
|
| 01.10.2025 |
Urgent Field Safety Notice for GM85 by Samsung Electronics Co. Limited
Product group Radiological technology -
mobile radiological diagnostic facilities
|
| 01.10.2025 |
Urgent Field Safety Notice for Standard Anatomische Pinhzette 11,0 cm by Tekno-Medical Optik Chirurgie GmbH
Product group Medical instruments for use in humans -
general instruments
|
| 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
|
| 02.10.2025 | New validation criteria for eCTD submissions - mandatory after 1 December 2025 |