Medical Device Manufacturer · SE , Gothenburg, Askim

Oticon Medical AB - FDA 510(k) Cleared Devices

16 submissions · 16 cleared · Since 2008
16
Total
16
Cleared
0
Denied
FDA 510(k) Regulatory Record - Oticon Medical AB Ear, Nose, Throat ✕
15 devices
1-15 of 15
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
Cleared Jun 15, 2011
PONTO PRO POWER
K103594 · LXB
Ear, Nose, Throat · 189d
Cleared Jul 29, 2009
PONTO PRO
K090996 · LXB
Ear, Nose, Throat · 112d
Cleared Nov 14, 2008
OBC BONE ANCHORED HEARING AID SYSTEM
K082108 · LXB
Ear, Nose, Throat · 112d
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