Initial Importers and manufacturers are required to report to the U.S. FDA, incidents in which a medical device may have caused or contributed to a death or serious injury as well as certain malfunctions.

ITB HOLDINGS LLC
390 North Orange Avenue, Suite 2300
Orlando, FL 32801
United States
T: +1 855 389 7344
T: +1 855 510 2240
T: +44 800 610 1577

https://www.itbhdg.com/initial-importer/