|
19.12.2025
|
Urgent Field Safety Notice for DR 800 by Agfa HealthCare N.V.
Product group Radiological technology -
stationary radiological equipment
Reference 55491/25
|
|
19.12.2025
|
Urgent Field Safety Notice for basixCOMPAK Inflation Device by Merit Medical Systems Inc.
Product group Injections / Infusions / Transfusions / Dialysis -
catheters
Reference 56933/25
|
|
19.12.2025
|
Urgent Field Safety Notice for cobas c 703 analytical unit by Roche Diagnostics GmbH
Product group In-vitro diagnostics -
equipment / products for clinical chemistry
Reference 57337/25
|
|
19.12.2025
|
Urgent Field Safety Notice for Automated Tube Sorter TS-10 by Sysmex Japan Corporation
Product group In-vitro diagnostics -
instruments, apparatuses and systems
Reference 58724/25
|
|
19.12.2025
|
Urgent Field Safety Notice for Syringe 10ml L/L 3parts Red plunger, (TAVI Set, AnngioSet) by Mölnlycke Health Care AB (Molndal)
Product group Injections / Infusions / Transfusions / Dialysis -
catheters
Reference 59615/25
|
|
19.12.2025
|
Urgent Field Safety Notice for Microsensor /CereLink ICP sensor Basic kit by Integra LifeSciences Corp.
Product group Medical electronics / Electromedical devices -
electrodiagnostics
Reference 60424/25
|
|
19.12.2025
|
Current processing statistics of the BfArM
State: November 2025
|
|
19.12.2025
|
Marketable medicinal products in the responsibility of the BfArM
On the following page you will find the figures of marketable medicinal products in the responsibility of the BfArM, broken down according to type of authorisation procedure as well as details of the authorisation status. The figures are updated on a monthly basis.
|
|
19.12.2025
|
Processing statistics
Here the BfArM publishes the current processing statistics of authorisations and registrations as well as of renewals. The figures are updated on a monthly basis.
|
|
18.12.2025
|
Notification of Medical Devices and In vitro Diagnostics
Medical devices and in vitro diagnostic devices as well as information on the PRRC have to be notified via DMIDS until 28 May 2026.
|
|
18.12.2025
|
Urgent Field Safety Notice for NOxBOXi by NOxBOX Ltd
Product group Surgical equipment/ Anaesthesia -
anaesthesia and medical gas supply
Reference 55827/25
|
|
17.12.2025
|
Winter Clock Stop for Clinical Trial Applications
Winter Clock Stop for Clinical Trial Applications from 22 Dec 2025 to 8 Jan 2026
|
|
17.12.2025
|
Urgent Field Safety Notice for Vanta/Sequentia LT Clinician Programmer Application by Medtronic Inc
Product group Active implantable medical devices -
programming and control equipment
Reference 57621/25
|
|
16.12.2025
|
Urgent Field Safety Notice for BD Alaris System Infusion Pump by BD Switzerland Sarl
Product group Injections / Infusions / Transfusions / Dialysis -
infusion technology
Reference 48593/25
|
|
16.12.2025
|
Urgent Field Safety Notice for SECUTRAY Angio-Set by SENGEWALD Klinikprodukte GmbH
Product group Injections / Infusions / Transfusions / Dialysis -
syringes and cannulas
Reference 54272/25
|
|
16.12.2025
|
Urgent Field Safety Notice for Head Fixation Device- HFD100 by Deerfield Imaging, Inc.
Product group Surgical equipment/ Anaesthesia -
surgical equipment
Reference 60228/25
|
|
16.12.2025
|
Urgent Field Safety Notice for ArTT - Trial Phantom Buttress by LIMACORPORATE S.P.A.
Product group Medical instruments for use in humans -
bone surgery
Reference 58021/25
|
|
16.12.2025
|
Direct Healthcare Professional Communication (DHPC) on melphalan hydrochloride, Melphalan AqVida 90 mg/ml concentrate for solution for infusion: potential risk of overdose due to higher concentration
Active substance: melphalan hydrochloride
AqVida GmbH would like to inform you that Melphalan AqVida 90 mg/ml is a melphalan formulation that is supplied in a single vial.
|
|
15.12.2025
|
Urgent Field Safety Notice for ORBIS Medication by DH Healthcare GmbH
Product group Medical data processing (software) -
others
Reference 58390/25
|
|
15.12.2025
|
Urgent Field Safety Notice for IntelliVue Patient Monitor by Philips Medizin Systeme Böblingen GmbH
Product group Medical electronics / Electromedical devices -
electrodiagnostics
Reference 52075/25
|
