How does the FDA work with U.S. Customs and Border Protection to ensure the safety of imported medical devices?

Nov 22, 2024 ... The US Food and Drug Administration (FDA) 510(k) clearance of remote scanning and remote protocol adjustment features on Philips Radiology Operations Command ... 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 ... Sep 13, 2024 ... ... FDA clearance for counting coughs. What Does "510(k) Clearance" Mean? When a medical device receives 510(k) clearance from the U.S. Food and ... Feb 9, 2025 ... “Prostate cancer is one of the most prevalent cancers worldwide, with an estimated one in eight men diagnosed in their lifetime. With the global ... 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, ... Apr 17, 2025 ... This 510(k) clearance is a testament to years of effort, and we are excited to bring this groundbreaking technology to physicians and their ... Feb 8, 2024 ... For comparison, the FDA mean review times were 150 days for 510(k)s ... And the 510(k) clearance pathway is generally easier and faster. Jan 27, 2025 ... LYNX is battery-powered and provides surgeons an untethered laser ... Faster LIO treatments means less ergonomic stress, more quality ... Sep 6, 2023 ... A Premarket Notification [510(k)], when the device is low to moderate risk and there is a legally marketed predicate device. Regardless of the ... Jan 24, 2023 ... What does this all mean for you? It means we did the work to ... What that means: A 510(k) filing contains detailed technical, safety ...