Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in FranceLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Teknimed with 15 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Dec 18, 2024: GENTAFIX® (1, 3, 3MV).
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 |
|---|---|---|
| Dec 18, 2024 | GENTAFIX® (1, 3, 3MV)K242216 · MBB | 510(k) clearances |
| May 12, 2023 | EUROSCREW NG; EUROSCREW TCP NGK230394 · MAI | 510(k) clearances |
| Dec 15, 2022 | HIGH V+ Spinal Cement System REF T040321KClass II · Incorrect expiry date. Product is labeled with expiry date 2027-02-28. The correct expiration date is 2025-02-28. | Device recalls |
| Apr 12, 2017 | HIGH V+K161114 · NDN | 510(k) clearances |
| Feb 4, 2011 | COHESION BONE CEMENTK103816 · NDN | 510(k) clearances |
| Jan 3, 2011 | F20K103433 · NDN | 510(k) clearances |
| Dec 21, 2009 | VERTECEMK090435 · NDN | 510(k) clearances |
| Mar 4, 2009 | NANGELK083005 · LYC | 510(k) clearances |
| Aug 28, 2008 | OPACITY + BONE CEMENTK080873 · NDN | 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
