Regulatory Approvals, Clearances and Quality Certificates FDA 510(k) Clearance August 2022 FDA 510(k) Clearance July 2020 FDA 510(k) Clearance December 2016 FDA 510(k) Clearance February 2016 FDA 510(k) Clearance February 2015 ISO 13485: 2016 MDSAP Certification EN ISO 13485:2016 Certification CE Marking Australian TGA Certificate Canada Medical License
