Data / Medical devices / Hearing Aid, Bone Conduction / Sweden
FDA-registered makers of Hearing Aid, Bone Conduction in Sweden: 7 establishments
7 establishments in Sweden are registered with the FDA to make Hearing Aid, Bone Conduction (product code LXB). 2 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Hearing Aid, Bone Conduction
- Product code
- LXB
- Country
- Sweden
Makers of Hearing Aid, Bone Conduction in Sweden
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Cochlear Bone Anchored Solutions AB | Molnlycke Vastra Gotaland, Sweden | Manufacturer, Specification developer | 11 | May 29, 2025 | 0 | 0 | 0 | api.fda.gov |
| Oticon Medical AB | Askim Vastra Gotaland, Sweden | Complaint file establishment, Specification developer | 8 | December 16, 2021 | 0 | 0 | 0 | api.fda.gov |
| Amb Industri AB | Broakulla Kalmar, Sweden | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cenova AB | MJOLBY Ostergotland, Sweden | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentsply IH AB | MOLNDAL Vastra Gotaland, Sweden | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elos Medtech Timmersdala AB | TIMMERSDALA Vastra Gotaland, Sweden | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| STOKVIS Nordic | Norrkoping Ostergotland, Sweden | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.