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Oticon Medical AB

16 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS (K240614)Oticon Medical AB2024-07-10
Ponto 5 SuperPower (K213733)Oticon Medical AB2021-12-16
Ponto 5 Mini (K211640)Oticon Medical AB2021-08-10
Ponto Bone Anchored Hearing System, MONO Surgery Kit (K203807)Oticon Medical AB2021-03-03
Ponto 4 (K190540)Oticon Medical AB2019-05-02
Ponto 3, Ponto 3 Power and Ponto 3 SuperPower (K161671)Oticon Medical AB2016-09-29
Ponto Bone Anchored Hearing System (K152820)Oticon Medical AB2016-01-22
Ponto bone anchored hearing system (K152067)Oticon Medical AB2015-11-23
Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutment, 14 mm (K142678)Oticon Medical AB2015-01-21
STERILIZATION CASSETTE (K141616)Oticon Medical AB2014-09-23
PONTO PLUS AND PONTO PLUS POWER (K132775)Oticon Medical AB2013-12-09
PONTO BONE ANCHORED HEARING SYSTEM (K121228)Oticon Medical AB2012-09-07
OBC BONE ANCHORED HEARING SYSTEM (K112053)Oticon Medical AB2011-11-18
PONTO PRO POWER (K103594)Oticon Medical AB2011-06-15
PONTO PRO (K090996)Oticon Medical AB2009-07-29
OBC BONE ANCHORED HEARING AID SYSTEM (K082108)Oticon Medical AB2008-11-14

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Every clearance here is in the API, with alerts when new ones post.