For more information on eligibility click the link. You can also download the current working model.Read More

Company: Varian Medical SystemsDate of Enforcement Report 10/10/2018 Class lI: PRODUCT VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The VitalBeam delivery systems are intended to provide precision radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated. Recall Number: Z-0005-2019 REASON Reports have been received of...Read More

Company: Varian Medical SystemsDate of Enforcement Report 10/3/2018 Class lI: PRODUCT TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated....Read More

Vancouver, BC Canada . Focused on global regulatory affairs and harmonization. For more information click the link provided. RAPS Regulatory ConvergenceRead More

October is National Cybersecurity Month; for more information from FDA click the link.Read More

Information on the FDA CDRH Patient Engagement Advisory Committee, including how to nominate candidates.Read More

FDA Center for Biologics provides manufacturers with technical assistance. For email and phone contact information, and other information about this service, click the link.Read More

Company: Radiometer America Inc.Date of Enforcement Report 10/3/2018 Class lI: PRODUCT ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated Analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. It is intended for use in a laboratory environment, near patient or...Read More