Oticon Medical AB is one of 117 FDA 510(k) medical device manufacturers from Sweden in the dataset, ranked by real submission volume.
Oticon Medical AB - FDA 510(k) Cleared Devices
Recent clearances: Ponto 5 Mini, Sentio Ti Implant Kit, Ponto 5 SuperPower
17
Total
17
Cleared
0
Denied
Oticon Medical AB has 17 FDA 510(k) cleared ear, nose, throat devices. Based in Gothenburg, Askim, SE.
Latest FDA clearance: Aug 2026. 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.
FDA 510(k) Regulatory Record - Oticon Medical AB
17 devices
Cleared
Aug 26, 2026
Ponto 5 Mini
Ear, Nose, Throat
141d
Cleared
Jul 10, 2024
Sentio Ti Implant Kit
Ear, Nose, Throat
127d
Cleared
Dec 16, 2021
Ponto 5 SuperPower
Ear, Nose, Throat
20d
Cleared
Aug 10, 2021
Ponto 5 Mini
Ear, Nose, Throat
75d
Cleared
Mar 03, 2021
Ponto Bone Anchored Hearing System, MONO Surgery Kit
Ear, Nose, Throat
65d
Cleared
May 02, 2019
Ponto 4
Ear, Nose, Throat
59d
Cleared
Sep 29, 2016
Ponto 3, Ponto 3 Power and Ponto 3 SuperPower
Ear, Nose, Throat
105d
Cleared
Jan 22, 2016
Ponto Bone Anchored Hearing System
Ear, Nose, Throat
116d
Cleared
Nov 23, 2015
Ponto bone anchored hearing system
Ear, Nose, Throat
122d
Cleared
Jan 21, 2015
Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored...
Ear, Nose, Throat
124d
Cleared
Sep 23, 2014
STERILIZATION CASSETTE
General Hospital
99d
Cleared
Dec 09, 2013
PONTO PLUS AND PONTO PLUS POWER
Ear, Nose, Throat
95d