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Oticon Medical AB

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

Total Devices7
Categories3
Latest FDA decision2024-07-10
TypeNumberDevice NameCodeDateActions
510(k) K240614 Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHSPFO2024-07-10 View
510(k) K213733 Ponto 5 SuperPowerLXB2021-12-16 View
510(k) K211640 Ponto 5 MiniLXB2021-08-10 View
510(k) K203807 Ponto Bone Anchored Hearing System, MONO Surgery KitMAH2021-03-03 View
510(k) K190540 Ponto 4LXB2019-05-02 View
510(k) K161671 Ponto 3, Ponto 3 Power and Ponto 3 SuperPowerLXB2016-09-29 View
510(k) K152820 Ponto Bone Anchored Hearing SystemMAH2016-01-22 View
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