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Oticon Medical AB

FDA 510(k) & PMA Approved Devices — 14 products

Total Devices14
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K261142 Ponto 5 Mini; Ponto 5 SuperpowerMAH2026-08-26 View
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
510(k) K132775 PONTO PLUS AND PONTO PLUS POWERLXB2013-12-09 View
510(k) K121228 PONTO BONE ANCHORED HEARING SYSTEMMAH2012-09-07 View
510(k) K112053 OBC BONE ANCHORED HEARING SYSTEMMAH2011-11-18 View
510(k) K103594 PONTO PRO POWERLXB2011-06-15 View
510(k) K090996 PONTO PROLXB2009-07-29 View
510(k) K082108 OBC BONE ANCHORED HEARING AID SYSTEMLXB2008-11-14 View
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