What are the requirements for reporting medical device malfunctions to the FDA?

Apr 2, 2024 ... "Olympus is your trusted stone management partner and now is positioned to provide access to a broad range of high-quality ureteroscopes, ... Sep 29, 2023 ... Many Software as a Medical Device and AI developers are looking to the US for a cheaper and speedier regulatory approval via an FDA 510(k) ... The FDA's 510(k) submission process is, in a nutshell, a clearance process which every company wanting to bring a medium-risk medical device to the American ... Nov 20, 2024 ... “THINK Surgical is excited to add the MOBIO™ Total Knee System to the TMINI System. The open platform version of TMINI is now available with ... Jan 30, 2025 ... In addition to the clearance, AI Optics is ... A total of 196 patients (48.5% women; mean age, 61 years) were identified who had been referred for ... Mar 9, 2022 ... Information that supported 510(k) cleared assays is publicly available! ... What does this mean? • Intended only for Employment and ... Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance. JAMA. 2023 Jan 10; ... Public documents for the 510(k) medical devices were collected using FDA ... Pending 510(k) clearance, not available for sale within the United States. Check out our next-generation MRI!! Page 11. □ “FDA does not intend to object to” ... Nov 30, 2020 ... The 510(k) regulatory clearance pathway is used to demonstrate to the FDA ... Notably, “substantially equivalent” does not mean identical! 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.