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

Oticon Medical AB has 16 FDA 510(k) cleared ear, nose, throat devices. Based in Gothenburg, Askim, SE.

Latest FDA clearance: Jul 2024. Active since 2008.

Browse the complete list of FDA 510(k) cleared ear, nose, throat devices from this manufacturer. Filter by specialty or product code using the sidebar.

16 devices
1–12 of 16
Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS
K240614 · PFO Active Implantable Bone Conduction Hearing System · Ear, Nose, Throat
Jul 2024 127d
Ponto 5 SuperPower
K213733 · LXB Hearing Aid, Bone Conduction · Ear, Nose, Throat
Dec 2021 20d
Ponto 5 Mini
K211640 · LXB Hearing Aid, Bone Conduction · Ear, Nose, Throat
Aug 2021 75d
Ponto Bone Anchored Hearing System, MONO Surgery Kit
K203807 · MAH Hearing Aid, Bone Conduction, Implanted · Ear, Nose, Throat
Mar 2021 65d
Ponto 4
K190540 · LXB Hearing Aid, Bone Conduction · Ear, Nose, Throat
May 2019 59d
Ponto 3, Ponto 3 Power and Ponto 3 SuperPower
K161671 · LXB Hearing Aid, Bone Conduction · Ear, Nose, Throat
Sep 2016 105d
Ponto Bone Anchored Hearing System
K152820 · MAH Hearing Aid, Bone Conduction, Implanted · Ear, Nose, Throat
Jan 2016 116d
Ponto bone anchored hearing system
K152067 · MAH Hearing Aid, Bone Conduction, Implanted · Ear, Nose, Throat
Nov 2015 122d
Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutment, 14 mm
K142678 · MAH Hearing Aid, Bone Conduction, Implanted · Ear, Nose, Throat
Jan 2015 124d
STERILIZATION CASSETTE
K141616 · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories · General Hospital
Sep 2014 99d
PONTO PLUS AND PONTO PLUS POWER
K132775 · LXB Hearing Aid, Bone Conduction · Ear, Nose, Throat
Dec 2013 95d
PONTO BONE ANCHORED HEARING SYSTEM
K121228 · MAH Hearing Aid, Bone Conduction, Implanted · Ear, Nose, Throat
Sep 2012 137d
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