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FDA 510(k) Applications Submitted by Oticon Medical AB
FDA 510(k) Number
Submission Date
Device Name
Applicant
K211640
05/27/2021
Ponto 5 Mini
Oticon Medical AB
K213733
11/26/2021
Ponto 5 SuperPower
Oticon Medical AB
K141616
06/16/2014
STERILIZATION CASSETTE
OTICON MEDICAL AB
K152067
07/24/2015
Ponto bone anchored hearing system
OTICON MEDICAL AB
K142678
09/19/2014
Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutment, 14 mm
OTICON MEDICAL AB
K152820
09/28/2015
Ponto Bone Anchored Hearing System
OTICON MEDICAL AB
K203807
12/28/2020
Ponto Bone Anchored Hearing System, MONO Surgery Kit
Oticon Medical AB
K090996
04/08/2009
PONTO PRO
OTICON MEDICAL AB
K082108
07/25/2008
OBC BONE ANCHORED HEARING AID SYSTEM
OTICON MEDICAL AB
K112053
07/19/2011
OBC BONE ANCHORED HEARING SYSTEM
OTICON MEDICAL AB
K121228
04/23/2012
PONTO BONE ANCHORED HEARING SYSTEM
OTICON MEDICAL AB
K190540
03/04/2019
Ponto 4
Oticon Medical AB
K161671
06/16/2016
Ponto 3, Ponto 3 Power and Ponto 3 SuperPower
OTICON MEDICAL AB
K132775
09/05/2013
PONTO PLUS AND PONTO PLUS POWER
OTICON MEDICAL AB
K103594
12/08/2010
PONTO PRO POWER
OTICON MEDICAL AB
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