Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Medtech S.A

FDA 510(k) & PMA Approved Devices — 6 products

Total Devices6
Categories2
Latest FDA decision2020-05-29
TypeNumberDevice NameCodeDateActions
510(k) K200511 ROSA ONE Brain applicationHAW2020-05-29 View
510(k) K192173 ROSA ONE Spine applicationOLO2019-10-29 View
510(k) K182848 ROSA ONE Spine applicationOLO2019-03-22 View
510(k) K182417 ROSA ONE Brain ApplicationHAW2019-02-07 View
510(k) K172444 ROSA BRAIN (v3.0.0.5)HAW2018-03-28 View
510(k) K151511 ROSA SpineOLO2016-01-04 View