Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in SwedenLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Ossdsign AB with 6 510(k) clearances. The most recent is a 510(k) clearance dated Sep 15, 2023: Catalyst Bone Void Filler.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Sep 15, 2023 | Catalyst Bone Void FillerK232315 · MQV | 510(k) clearances |
| Oct 1, 2021 | OSSDSIGN Cranial PSIK212414 · PJN | 510(k) clearances |
| Oct 10, 2019 | Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical Model Modified, Cranial PSI Accessory – Plastic Drawing Guide, Cranial PSI Accessory – Cranial Implant TrialK190523 · PJN | 510(k) clearances |
| Oct 12, 2018 | OSSDSIGN CranioplugK181539 · GXR | 510(k) clearances |
| Jan 19, 2017 | Cranial PSIK161090 · GXN | 510(k) clearances |
| Oct 3, 2014 | CRANIOPLUGK140309 · GXR | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
