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

Oticon Medical AB

FDA 510(k) & PMA Approved Devices — 7 products

Total Devices7
Categories3
Latest Approval2024-07-10
TypeNumberDevice NameCodeDate
510(k) K240614 Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS PFO 2024-07-10 View
510(k) K213733 Ponto 5 SuperPower LXB 2021-12-16 View
510(k) K211640 Ponto 5 Mini LXB 2021-08-10 View
510(k) K203807 Ponto Bone Anchored Hearing System, MONO Surgery Kit MAH 2021-03-03 View
510(k) K190540 Ponto 4 LXB 2019-05-02 View
510(k) K161671 Ponto 3, Ponto 3 Power and Ponto 3 SuperPower LXB 2016-09-29 View
510(k) K152820 Ponto Bone Anchored Hearing System MAH 2016-01-22 View
↑