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Oticon Medical AB

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
16
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K240614Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHSJuly 10, 2024
K213733Ponto 5 SuperPowerDecember 16, 2021
K211640Ponto 5 MiniAugust 10, 2021
K203807Ponto Bone Anchored Hearing System, MONO Surgery KitMarch 3, 2021
K190540Ponto 4May 2, 2019
K161671Ponto 3, Ponto 3 Power and Ponto 3 SuperPowerSeptember 29, 2016
K152820Ponto Bone Anchored Hearing SystemJanuary 22, 2016
K152067Ponto bone anchored hearing systemNovember 23, 2015
K142678Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implanJanuary 21, 2015
K141616STERILIZATION CASSETTESeptember 23, 2014
K132775PONTO PLUS AND PONTO PLUS POWERDecember 9, 2013
K121228PONTO BONE ANCHORED HEARING SYSTEMSeptember 7, 2012
K112053OBC BONE ANCHORED HEARING SYSTEMNovember 18, 2011
K103594PONTO PRO POWERJune 15, 2011
K090996PONTO PROJuly 29, 2009
K082108OBC BONE ANCHORED HEARING AID SYSTEMNovember 14, 2008