How does the FDA evaluate the potential for allergic reactions to medical device materials?

FDA has a clear definition of the 510(k) pathway which allows manufacturers ... FDA's Premarket Approval (PMA) pathway. The European Union CE marking ... Mar 14, 2024 ... The US Food and Drug Administration (FDA) provided 510(k) clearance for da Vinci 5, the company's next-generation multiport robotic system. Jan 7, 2025 ... This new, 25-gauge 180-mm Smart Tip will allow for the treatment of deeper nerves, such as the medial branch nerve and is specifically designed so that it can ... Dec 10, 2019 ... The InSet™ Total Shoulder System is used to treat significant disability in degenerative, rheumatoid, and traumatic disease of the glenohumeral ... To receive FDA approval on a new device intended for human use, a premarket submission called a 510k must be made to the FDA. This must demonstrate that the ... Apr 11, 2023 ... A 510(k) clearance means that FDA has completed its review of the 510(k) review and determined that the device is substantially equivalent to an ... 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 ... Sep 19, 2023 ... The T2Biothreat Panel is a direct-from-blood molecular diagnostic test that runs on the FDA-cleared T2Dx® Instrument and simultaneously detects six biothreat ... Nov 13, 2024 ... It includes the latest features used in molecular imaging and simplifies workflows significantly. This is a new milestone in NM Processing and ... 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?