30.01.2025
|
Urgent Field Safety Notice for 2.0/2.3 TriLock Plate MC I Base, t1.0 by Medartis AG
Product group Non-active implants -
bone surgery
Reference 02738/25
|
30.01.2025
|
Non-interventional studies („Anwendungsbeobachtungen“, post-authorisation safety studies)
Non-interventional studies („Anwendungsbeobachtungen“, post-authorisation safety studies)
|
29.01.2025
|
Urgent Field Safety Notice for APC (Schneider Electric IT Corporation) UPS by Philips Medical Systems: Important update regarding Urgent Field Safety Notice 2024-CC-HPM-010 from March 2024
Product group Medical electronics / Electromedical devices -
electrodiagnostics
Reference 11175/24
|
28.01.2025
|
Urgent Field Safety Notice for NexGen Legacy Constrained Condylar Knee by Zimmer Inc.
Product group Non-active implants -
bone surgery
Reference 02348/25
|
28.01.2025
|
Urgent Field Safety Notice for BAGUERA C / BAGUERA L by SPINEART S. (Plan-Les-Ouates)
Product group Non-active implants -
bone surgery
Reference 43780/24
|
28.01.2025
|
Urgent Field Safety Notice for VNS Therapy SenTiva Generator by LivaNova, Inc
Product group Active implantable medical devices -
biostimulators
Reference 02087/25
|
28.01.2025
|
Urgent Field Safety Notice for Achieva TX Interventional Coil 3.0T, dS Breast 16c by PHILIPS HEALTHCARE FRANCE
Product group Electromedical fields -
equipment for MR tomography
Reference 38752/24
|
28.01.2025
|
Urgent Field Safety Notice for IntelliBridge EC10 Module by Philips Medizin Systeme Böblingen GmbH
Product group Medical electronics / Electromedical devices -
electrodiagnostics
Reference 01612/25
|
28.01.2025
|
Urgent Field Safety Notice for Nasal Splints by Exmoor Plastics Ltd.
Product group Non-active implants -
bone surgery
Reference 01937/25
|
28.01.2025
|
Urgent Field Safety Notice for Optipac Vacuum mixing systemt by Biomet France SARL
Product group Non-active implants -
materials for implants
Reference 01479/25
|
28.01.2025
|
Proposal procedure to maintain OPS and ICD-10-GM
The proposal procedure for the next version 2025 of ICD-10-GM and OPS has been opened.
|
27.01.2025
|
Urgent Field Safety Notice for HPS 2.0 Rod coupler, S=25N/mm, 27mm by Paradigm Spine GmbH
Product group Non-active implants -
bone surgery
Reference 23795/24
|
27.01.2025
|
Urgent Field Safety Notice for AK 95, AK 96, AK 98 by Gambro Lundia AB
Product group Injections / Infusions / Transfusions / Dialysis -
dialysis technology
Reference 02239/25
|
27.01.2025
|
Advisory Council for Delivery and Supply Shortages
According to section 52b subsection 3b of the Medicinal Products Act, the Federal Institute for Drugs and Medical Devices is empowered to set up an Advisory Council to continuously monitor and evaluate the overall supply situation in Germany.
|
24.01.2025
|
Urgent Field Safety Notice for SIGNA Prime by GE HEALTHCARE (TIANJIN) COMPANY LIMITED
Product group Electromedical fields -
equipment for MR tomography
Reference 02161/25
|
24.01.2025
|
Urgent Field Safety Notice for VNS Therapy SenTiva Generator by LivaNova, Inc
Product group Active implantable medical devices -
biostimulators
Reference 01958/25
|
24.01.2025
|
Urgent Field Safety Notice for ZNN BACTIGUARD Retrograde Femoral Nail by Bactiguard (South East Asia) Sdn. Bhd.
Product group Non-active implants -
bone surgery
Reference 02211/25
|
24.01.2025
|
Urgent Field Safety Notice for STERILCONTAINERSYSTEM BASIS / AICON by Aesculap AG
Product group General equipment for medical treatment -
cleaning / disinfection / sterilisation
Reference 01792/25
|
24.01.2025
|
Save the date – next Iris webinar
The next Iris webinar will be held on 19th February 2025.
|
23.01.2025
|
Urgent Field Safety Notice for Lumenis Pulse 120H Holmium Laser Systems by Lumenis Ltd.
Product group Optics / Precision engineering -
laser technology
Reference 02022/25
|