29/10/2024 -
During an internal investigation, Integra Lifesciences identified higher than expected levels of endotoxin within the raw material used to product CODMAN® Surgical Patties and Strips that may have...
25/09/2024 -
Seguridad de los dispositivos médicos: desde vendajes hasta marcapasos, Salud Canadá garantiza que los beneficios superen los riesgos y monitorea su uso posterior a su...
25/09/2024 -
Baxter Corporation is issuing an urgent medical device correction for the TruSystem 7000 surgical table due to customer reports stating that the batteries and their connectors experienced...
25/09/2024 -
Los informes de desempeño trimestrales de la Dirección de Dispositivos Médicos proporcionan métricas detalladas sobre la puntualidad del proceso de revisión de...
25/09/2024 -
This guidance document has been updated to expand on the definition of "significant change" in the Medical Devices Regulations (regulations). This will help you determine whether a...
25/09/2024 -
Los informes de desempeño trimestrales de la Dirección de Dispositivos Médicos proporcionan métricas detalladas sobre la puntualidad del proceso de revisión de...
25/09/2024 -
The Medical Devices Directorate’s Annual Performance Report provide detailed metrics about the timeliness of pre-market medical devices review process against the performance service...
25/09/2024 -
Boston Scientific is retrieving specific model l331 ACCOLADE™ pacemakers due to inadvertent re-use/duplication of certain model/serial number combinations. This duplication occurred during...