Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in ItalyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Tecres S.p.A. with 15 510(k) clearances and 1 warning letter. The most recent is a 510(k) clearance dated Aug 6, 2025: InterSpace GV Hip Spacer.
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 |
|---|---|---|
| Aug 6, 2025 | InterSpace GV Hip SpacerK252326 · KWL | 510(k) clearances |
| Jan 9, 2023 | Bone Cement Genta, Bone Cement HV, Bone Cement LVK211163 · LOD | 510(k) clearances |
| Apr 18, 2022 | KYPHON VuE Bone CementK220131 · NDN | 510(k) clearances |
| Aug 20, 2019 | Warning letter: Medical DevicesCDRH | Warning letters |
| Apr 27, 2019 | InterSpace Knee Extra-Large Size, InterSpace Knee ATSK181732 · JWH | 510(k) clearances |
| Mar 28, 2013 | MENDEC SPINE HV, MENDEC SPINE HV SYSTEMK122175 · NDN | 510(k) clearances |
| Dec 12, 2011 | SPACER-SK112983 · HSD | 510(k) clearances |
| Sep 20, 2011 | Spacer-G and Spacer-KK101356 · KWL | 510(k) clearances |
| Nov 24, 2009 | CEMEX GENTA, GENTA SYSTEM AND GENTA SYSTEM FASTK092773 · LOD | 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
