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Company · SE

Oticon Medical AB

FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2026. Name variants (Inc, Corp, punctuation) are merged.

17510(k) clearances (1 in 12 months)

0recalls (0 in 12 months)

0recalls that name a 510(k)

Product codes

Code	Device	Records
LXB	Hearing Aid, Bone Conduction	8
MAH	Hearing Aid, Bone Conduction, Implanted	7
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	1
PFO	Active Implantable Bone Conduction Hearing System	1

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
Aug 26, 2026	K261142	Ponto 5 Mini; Ponto 5 Superpower Oticon Medical AB, SE	MAH
Jul 10, 2024	K240614	Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS Oticon Medical AB, SE	PFO
Dec 16, 2021	K213733	Ponto 5 SuperPower Oticon Medical AB, SE	LXB
Aug 10, 2021	K211640	Ponto 5 Mini Oticon Medical AB, SE	LXB
Mar 3, 2021	K203807	Ponto Bone Anchored Hearing System, MONO Surgery Kit Oticon Medical AB, SE	MAH
May 2, 2019	K190540	Ponto 4 Oticon Medical AB, SE	LXB
Sep 29, 2016	K161671	Ponto 3, Ponto 3 Power and Ponto 3 SuperPower Oticon Medical AB, SE	LXB
Jan 22, 2016	K152820	Ponto Bone Anchored Hearing System Oticon Medical AB, SE	MAH
Nov 23, 2015	K152067	Ponto bone anchored hearing system Oticon Medical AB, SE	MAH
Jan 21, 2015	K142678	Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutmen Oticon Medical AB, SE	MAH
Sep 23, 2014	K141616	STERILIZATION CASSETTE Oticon Medical AB, SE	KCT
Dec 9, 2013	K132775	PONTO PLUS AND PONTO PLUS POWER Oticon Medical AB, SE	LXB
Sep 7, 2012	K121228	PONTO BONE ANCHORED HEARING SYSTEM Oticon Medical AB, SE	MAH
Nov 18, 2011	K112053	OBC BONE ANCHORED HEARING SYSTEM Oticon Medical AB, SE	MAH
Jun 15, 2011	K103594	PONTO PRO POWER Oticon Medical AB, SE	LXB
Jul 29, 2009	K090996	PONTO PRO Oticon Medical AB, SE	LXB
Nov 14, 2008	K082108	OBC BONE ANCHORED HEARING AID SYSTEM Oticon Medical AB, SE	LXB

Latest recalls

Date	Firm and product	Code	Linked 510(k)
No recalls in this window.

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