100th FDA 510(k) Clearance by PaxMed’s Dr. Kevin A. Thomas

PaxMed International assists our clients with U.S. Food and Drug Administration (FDA) and other regulatory approvals, including 510(k) submissions for Class II medical devices. We would like to recognize our Vice President and Director of Regulatory Affairs, Kevin A. Thomas, PhD, on his 100th FDA 510(k) clearance on August 14, 2023! During his 15 years with PaxMed, he has authored many of our 510(k)s and one of PaxMed’s latest 510(k) clearances is a milestone in Kevin’s career with PaxMed. Class II medical device submissions are not for the faint of heart! As a company, we are proud of the 284 clearances that we have achieved, and we are grateful for every employee and client that has aided us with this remarkable achievement.

Kevin’s 100th 510(k) submission was a collaborative effort with our client, Terrats Medical S.L., of Barcelona, Spain. Terrats Medical received a Substantially Equivalent (SE) notification from FDA for their latest 510(k) submission for DESS Dental Smart Solutions. PaxMed has worked with Terrats Medical over the past seven years on twelve successful 510(k) submissions. Please join us in congratulating Kevin on this achievement.