What are the sterilization requirements for reusable surgical instruments?

Nov 29, 2023 ... With this unprecedented FDA clearance, Vivos redefines what it means to have a truly non-invasive treatment for all levels of OSA severity. Many of the products submitted to the FDA for clearance use the 510(k) regulatory approval process. ... The phrase “substantially equivalent” means your ... Jan 12, 2024 ... The COVID-19 public health emergency (PHE) declaration expired on May 11, 2023, which means termination of medical device Emergency Use ... Mar 21, 2022 ... Developing a new medical device? Here's how much time and cash it could take to get FDA 510(k) clearance or De Novo classification. Jul 29, 2024 ... The FDA's action means that SPIRA-A Integrated is now indicated for use at one or more levels, from L1-S1 as an adjunct to fusion in skeletally ... Oct 4, 2023 ... Anumana's ECG-AI LEF is an innovative software-as-a-medical device (SaMD) designed to screen for LEF in adults at risk for heart failure. The 510(k) pathway allows the clearance of a new medical device if the manufacturer shows that the device is substantially equivalent to one or more legally ... Apr 16, 2017 ... FDA's analysis of whether to exempt a type of device from the 510(k) requirements is specific to the devices within the generic category in ... Mar 9, 2022 ... Information that supported 510(k) cleared assays is publicly available! ... What does this mean? • Intended only for Employment and ... Aug 4, 2022 ... “When Xoran states that TRON is the 'One RING to rule them all,' we truly mean that this compact, mobile, open-bore device is poised to ...