Company: Biosense Webster, Inc. Date of Enforcement Report 9/21/11 Class ll: PRODUCT STOCKERT 70 Radio Frequency Generator, Catalog Number 57001 Indicated for use with a Biosense Webster, Inc. diagnostic/ablation deflectable tip catheter to deliver radio frequency energy during cardiac ablation procedures. Stockert 70 in foreign countries is also known as: EP-Shuttle/Stockert J50/Stockert J70 With software...Read More

Company: Roche Diagnostics Operations, Inc.Date of Enforcement Report 9/21/11 Class ll: PRODUCT 1) MagNA Pure LC 1.0 (software version 3.0.11). An automated instrument used for isolation of nucleic acids (DNA, total RNA, total viral nucleic acids) from different kinds of biological research sample material (whole blood, serum, blood cells, culture cells, tissue, bacteria, fungi) using...Read More

SoftwareCPR participates in standards development and provides a premium subscription to provide additional insight and access to the development of new standards. The link, In Play 2011-09, is to one of Standards Navigator subscriber documents titled, “In play: The changing health and medical device software standards landscape.” This is updated regularly and includes the changes and new standards...Read More