Applied Silicone is a global supplier of implantable silicone material for the critical healthcare and medical device markets. The company specializes in long-term implantable silicone proven with 25 years of successful clinical use. Applied Silicone offers high purity silicone gels, elastomer dispersions, adhesives, LSR, HCR, lubricant coatings, primers, fluids, sheeting, and custom formulations.
Applied Silicone’s experienced team can support you with material selection, performance testing, processing, qualification, design validation, and regulatory submissions. Our products are designed to meet FDA and ISO 10993 biocompatibility requirements with GMP-based manufacturing and ISO 9001:2008 certified quality system. Master Access Files have been registered with the FDA and compendium summaries are available to support regulatory submissions for Class II and III medical devices.