Tecnología Médica
Mapa TecMedTecnología Médica
Disposición Nº 6607/2024
06/08/2024 -
Prohíbese el uso, comercialización y distribución en todo el territorio nacional de todos los productos que declaren haber sido esterilizados y envasados por OXIVAC SRL, hasta...
Howmedica Revision Instrument System (HRIS) Storage & Sterilization Case and Tray
07/06/2024 -
Gray revision instruments are single-use, sterile-packaged manual surgical instruments intended for one-time use during hip or knee arthroplasty, or trauma surgeries. The HRIS storage &...
Disposición N° 809/2024
14/02/2024 -
Prohíbese el uso, comercialización y distribución en todo el territorio nacional de los productos médicos identificados como:”Facoemulsificador Sovereign Compact...
FDA Facilitates Broader Adoption of Vaporized Hydrogen Peroxide for Medical Device Sterilization
22/01/2024 -
FDA Facilitates Broader Adoption of Vaporized Hydrogen Peroxide for Medical Device Sterilization
Alerta 4240 (Tecnovigilância) - Comunicado da empresa D&I Comércio de Equipamentos Médicos Ltda - Autoclave Steelco. Falha do sensor. Interrupção do ciclo de esterilização. Emissão de mensagem de erro do dispositivo.
25/08/2023 -
A empresa tomou conhecimento da exposição de operadores a níveis descontrolados de vapor de formaldeído durante a operação do modelo de unidade de...
Statclave G4 Chamber Autoclaves
26/07/2023 -
An error in production resulted in missing gaskets in some units on float sensors in the reservoirs. The units were not leaking when they left the facility, however a leak will develop over time...
Olympus Tracheal Intubation Scopes
05/07/2023 -
The tracheal intubation scopes, LF-V and LF-P, have been listed as compatible with Olympus endoscope reprocessors (models OER-pro and OER-elite). the OER-pro endoscope reprocessor was the first...
FDA Continues Efforts to Support Innovation in Medical Device Sterilization
04/08/2022 -
FDA Continues Efforts to Support Innovation in Medical Device Sterilization
Use the Correct Cycle and Compatible N95 Respirators When Decontaminating Respirators with STERRAD Sterilization Systems – Letter to Health Care Providers
29/05/2020 -
The FDA is reminding reprocessing staff in health care facilities to use the correct decontamination cycle associated with certain models of the ASP STERRAD Sterilization Systems to decontaminate...
