Datascope Corporation Product: Medical Device Date: 2/6/19 The United States Food and Drug Administration (FDA) conducted an inspection of your firm’s medical device operations at 1300 Macarthur Blvd., Mahwah, NJ, from July 30, 2018 through October 3, 2018. During the inspection, FDA investigators determined that your firm is a of intra-aortic balloon pumps (IABPs) and Cardiosave...Read More
Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report: 1/29/2019 Class II PRODUCT Atellica IM 1300 Analyzer; In-vitro diagnostic testing of clinical specimens; Siemens Material Number (SMN): 1066001 Product Usage: The Atellica Solution is a multi-component system for in-vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of...Read More
FDA and 62304 Training – Boston – June 4-6, 2019
3-day course is designed to gain an understanding of how 62304 and other standards can be implemented efficiently and effectively while meeting FDA expectations as well. John F. Murray, Jr., will be among the faculty!