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


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact