Oticon Medical AB - FDA 510(k) Cleared Devices

Cleared Jul 10, 2024

Sentio Ti Implant Kit

K240614 · PFO

Ear, Nose, Throat · 127d

Cleared Dec 16, 2021

Ponto 5 SuperPower

K213733 · LXB

Ear, Nose, Throat · 20d

Cleared Aug 10, 2021

Ponto 5 Mini

K211640 · LXB

Ear, Nose, Throat · 75d

Cleared Mar 03, 2021

Ponto Bone Anchored Hearing System, MONO Surgery Kit

K203807 · MAH

Ear, Nose, Throat · 65d

Cleared May 02, 2019

Ponto 4

K190540 · LXB

Ear, Nose, Throat · 59d

Cleared Sep 29, 2016

Ponto 3, Ponto 3 Power and Ponto 3 SuperPower

K161671 · LXB

Ear, Nose, Throat · 105d

Cleared Jan 22, 2016

Ponto Bone Anchored Hearing System

K152820 · MAH

Ear, Nose, Throat · 116d

Cleared Nov 23, 2015

Ponto bone anchored hearing system

K152067 · MAH

Ear, Nose, Throat · 122d

Cleared Jan 21, 2015

Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored...

K142678 · MAH

Ear, Nose, Throat · 124d

Cleared Dec 09, 2013

PONTO PLUS AND PONTO PLUS POWER

K132775 · LXB

Ear, Nose, Throat · 95d

Cleared Sep 07, 2012

PONTO BONE ANCHORED HEARING SYSTEM

K121228 · MAH

Ear, Nose, Throat · 137d

Cleared Nov 18, 2011

OBC BONE ANCHORED HEARING SYSTEM

K112053 · MAH

Ear, Nose, Throat · 122d