Oticon Medical AB
Oticon Medical AB appears in FDA public data with 0 recalls, 17 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on Aug 26, 2026.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 17
- Inspections
- 1
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K261142 | Ponto 5 Mini; Ponto 5 Superpower | Aug 26, 2026 |
| K240614 | Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS | Jul 10, 2024 |
| K213733 | Ponto 5 SuperPower | Dec 16, 2021 |
| K211640 | Ponto 5 Mini | Aug 10, 2021 |
| K203807 | Ponto Bone Anchored Hearing System, MONO Surgery Kit | Mar 3, 2021 |
| K190540 | Ponto 4 | May 2, 2019 |
| K161671 | Ponto 3, Ponto 3 Power and Ponto 3 SuperPower | Sep 29, 2016 |
| K152820 | Ponto Bone Anchored Hearing System | Jan 22, 2016 |
| K152067 | Ponto bone anchored hearing system | Nov 23, 2015 |
| K142678 | Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implan | Jan 21, 2015 |
| K141616 | STERILIZATION CASSETTE | Sep 23, 2014 |
| K132775 | PONTO PLUS AND PONTO PLUS POWER | Dec 9, 2013 |
| K121228 | PONTO BONE ANCHORED HEARING SYSTEM | Sep 7, 2012 |
| K112053 | OBC BONE ANCHORED HEARING SYSTEM | Nov 18, 2011 |
| K103594 | PONTO PRO POWER | Jun 15, 2011 |
| K090996 | PONTO PRO | Jul 29, 2009 |
| K082108 | OBC BONE ANCHORED HEARING AID SYSTEM | Nov 14, 2008 |