Are there any exemptions from the 510(k) requirement?

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 ... Oct 1, 2024 ... ... (FDA) for its PlaqueIQ™ imaging analysis software to help physicians diagnose cardiovascular disease (CVD). PlaqueIQ is the first FDA-cleared ... Apr 19, 2023 ... At this time, the FDA does NOT approve hearing aids, and no one can claim that a hearing aid is FDA-approved. What is 510(k) FDA approval? Jan 27, 2025 ... LYNX is battery-powered and provides surgeons an untethered laser ... Faster LIO treatments means less ergonomic stress, more quality ... Many of the products submitted to the FDA for clearance use the 510(k) regulatory approval process. ... The phrase “substantially equivalent” means your ... Dec 22, 2021 ... The FDA clearance is based on data from multiple studies of the ... mean tear film breakup time and meibomian gland secretion score ... It is important to seek feedback from FDA at a time when it will be of most value. o Initiating a pre-submission meeting early might mean that you still have ... Oct 6, 2020 ... Although FDA's 510(k) program is the most ... clearance, meaning that manufacturers can market their device without clearance from the FDA. Feb 11, 2025 ... That's actually why screening is so important—it doesn't have symptoms until it's advanced. For example, bone pain would mean the cancer has ... 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.