Data / Medical devices / Sweden / Oticon Medical AB
Oticon Medical AB: FDA-registered device maker in Askim Vastra Gotaland, Sweden, 16 510(k) clearances
Oticon Medical AB is registered with the FDA (registration 3007367732) in Askim Vastra Gotaland, Sweden. It lists 6 device types. The FDA files 16 510(k) clearances under its listings, the newest dated August 26, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007367732
- Address
- Datavagen 37B, Askim Vastra Gotaland, Sweden, 43632
- Owner or operator
- DEMANT A/S (8010048)
- Roles
- Complaint file establishment, Foreign private label distributor, Manufacturer, Specification developer
- First device listed
- December 29, 2008
- Registered through
- 2026
- Brand names listed
- Abutment inserter, machine, Abutment, 12mm, Abutment, 14 mm, Abutment, 6 mm, Abutment, 9 mm, Counter torque wrench, Cover screw hexagon, Double-ended dissector and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Active Implantable Bone Conduction Hearing System | PFO | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Hearing Aid, Air-Conduction, Prescription | ESD | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Hearing Aid, Bone Conduction | LXB | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Hearing Aid, Bone Conduction, Implanted | MAH | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Instrument, Ent Manual Surgical | LRC | 1 | Complaint file establishment, Foreign private label distributor, Specification developer | accessdata.fda.gov |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 26, 2026 | K261142 | Ponto 5 Mini; Ponto 5 Superpower | MAH | Substantially Equivalent | Oticon Medical AB | accessdata.fda.gov |
| July 10, 2024 | K240614 | Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS | PFO | Substantially Equivalent | Oticon Medical AB | accessdata.fda.gov |
| December 16, 2021 | K213733 | Ponto 5 SuperPower | LXB | Substantially Equivalent | Oticon Medical AB | accessdata.fda.gov |
| August 10, 2021 | K211640 | Ponto 5 Mini | LXB | Substantially Equivalent | Oticon Medical AB | accessdata.fda.gov |
| March 3, 2021 | K203807 | Ponto Bone Anchored Hearing System, MONO Surgery Kit | MAH | Substantially Equivalent | Oticon Medical AB | accessdata.fda.gov |
| May 2, 2019 | K190540 | Ponto 4 | LXB | Substantially Equivalent | Oticon Medical AB | accessdata.fda.gov |
| September 29, 2016 | K161671 | Ponto 3, Ponto 3 Power and Ponto 3 SuperPower | LXB | Substantially Equivalent | Oticon Medical AB | accessdata.fda.gov |
| November 23, 2015 | K152067 | Ponto bone anchored hearing system | MAH | Substantially Equivalent | Oticon Medical AB | accessdata.fda.gov |
| January 21, 2015 | K142678 | Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutment, 14 mm | MAH | Substantially Equivalent | Oticon Medical AB | accessdata.fda.gov |
| September 23, 2014 | K141616 | STERILIZATION CASSETTE | KCT | Substantially Equivalent | Oticon Medical AB | accessdata.fda.gov |
| December 9, 2013 | K132775 | PONTO PLUS AND PONTO PLUS POWER | LXB | Substantially Equivalent | Oticon Medical AB | accessdata.fda.gov |
| September 7, 2012 | K121228 | PONTO BONE ANCHORED HEARING SYSTEM | MAH | Substantially Equivalent | Oticon Medical AB | accessdata.fda.gov |
| November 18, 2011 | K112053 | OBC BONE ANCHORED HEARING SYSTEM | MAH | Substantially Equivalent | Oticon Medical AB | accessdata.fda.gov |
| June 15, 2011 | K103594 | PONTO PRO POWER | LXB | Substantially Equivalent | Oticon Medical AB | accessdata.fda.gov |
| July 29, 2009 | K090996 | PONTO PRO | LXB | Substantially Equivalent | Oticon Medical AB | accessdata.fda.gov |
| November 14, 2008 | K082108 | OBC BONE ANCHORED HEARING AID SYSTEM | LXB | Substantially Equivalent | Oticon Medical AB | accessdata.fda.gov |
Compare with other makers
- All makers of Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- All makers of Hearing Aid, Bone Conduction, Implanted
- All makers of Hearing Aid, Bone Conduction
- All makers of Hearing Aid, Air-Conduction, Prescription
- All makers of Instrument, Ent Manual Surgical
- All makers of Active Implantable Bone Conduction Hearing System
Updated August 26, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.