All news at a glance
| Date | Title: |
|---|---|
| 20.11.2025 |
Urgent Field Safety Notice for Anti-GBM by Orgentec Diagnostika GmbH
Product group In-vitro diagnostics -
haematological, histological and cytological products
|
| 20.11.2025 |
Urgent Field Safety Notice for GBM Ab by Demeditec Diagnostics GmbH
Product group In-vitro diagnostics -
haematological, histological and cytological products
|
| 20.11.2025 |
Urgent Field Safety Notice for Ultrasound system type 2300, 1300, 1202 by B-K Medical A/S
Product group Ultrasonics -
ultrasonic diagnostic equipment
|
| 20.11.2025 |
Urgent Field Safety Notice for ACCELLA THERAPY STANDALONE MAT by Hill-Rom SAS
Product group General equipment for medical treatment -
furnishings
|
| 20.11.2025 | Information Iris Webinar - January 2026 |
| 20.11.2025 | Official Launch of Iris Version 6 |
| 18.11.2025 |
Urgent Field Safety Notice for Defigard Touch 7 by Schiller Medical SAS
Product group Medical electronics / Electromedical devices -
electrotherapy
|
| 18.11.2025 |
Urgent Field Safety Notice for GCE Zen-O lite by Gas Control Equipment Ltd
Product group Physical therapy -
inhalation therapy
|
| 18.11.2025 |
Urgent Field Safety Notice for Sectra Core by Sectra Imtec AB
Product group Radiological technology -
auxiliary equipment and supplies for radiology / nuclear medicine
|
| 14.11.2025 |
Urgent Field Safety Notice for SLsolution by Copan Italia S.p.A.
Product group In-vitro diagnostics -
microbiological products
|
| 14.11.2025 |
Urgent Field Safety Notice for Access 2 Reaction Vessel by Beckman Coulter, Inc.
Product group In-vitro diagnostics -
equipment / products for clinical chemistry
|
| 13.11.2025 |
Urgent Field Safety Notice for CompoFlow, Composelect by Fresenius Kabi AG
Product group Injections / Infusions / Transfusions / Dialysis -
equipment for collecting blood products and peripheral stem cells
|
| 12.11.2025 |
Urgent Field Safety Notice for Lumify by Philips Ultrasound, Inc.
Product group Ultrasonics -
ultrasonic diagnostic equipment
|
| 12.11.2025 |
Urgent Field Safety Notice for LOOP by OLYMPUS EUROPA S. & Co. KG
Product group Optics / Precision engineering -
endoscopes
|
| 12.11.2025 | Most common considerations when submitting an initial application or a substantial modification |
| 11.11.2025 |
Urgent Field Safety Notice for AMNIOQUICK CARD (Ref 1090005) AMNIOQUICK CARD BSX (Ref 1090005_BSX) AMNIOQUICK DUO+ (Ref 1090004) AMNIOQUICK DUO+ BSX (Ref 1090004_BSX) by BIOSYNEX SA
Product group In-vitro diagnostics -
immunological products
|
| 11.11.2025 |
Urgent Field Safety Notice for ORBIS Medication by DH Healthcare GmbH
Product group Medical data processing (software) -
others
|
| 11.11.2025 |
Urgent Field Safety Notice for Vapor 2000 and Vapor 3000 by Drägerwerk AG & Co. KGaA
Product group Surgical equipment/ Anaesthesia -
anaesthesia and medical gas supply
|
| 11.11.2025 |
Urgent Field Safety Notice for ZAP-X Radiosurgery System, 300150 by ZAP Surgical Systems, Inc.
Product group Radiotherapy / Radiation protection -
radiation facilites with accelerators for teletherapy
|
| 11.11.2025 |
Urgent Field Safety Notice for Ambu SPUR II by AMBU A/S
Product group Surgical equipment/ Anaesthesia -
anaesthesia and medical gas supply
|