What are the different types of enforcement actions that the FDA can take against manufacturers of non-compliant medical devices?

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. Jan 30, 2023 ... ... dose concerns mean CT is not optimal. Adaptix's central mission is to transform radiology by offering affordable low-dose 3D imaging at the ... 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 ... Jan 12, 2024 ... The COVID-19 public health emergency (PHE) declaration expired on May 11, 2023, which means termination of medical device Emergency Use ... May 6, 2021 ... What is the risk of recall and high-risk recall for devices undergoing US Food and Drug Administration (FDA) 510(k) clearance compared with ... 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 ... Deliver more personalised digital-first care and research with our enterprise platform which now has FDA 510 (K) Class II clearance for any physician-specified ... 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 ... 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) ... 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 ...