Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in GermanyLabelled 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 15, 2026, FDA's public records list Somatex Medical Technologies with 7 510(k) clearances and 2 device recalls. The most recent is a 510(k) clearance dated Feb 18, 2021: Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape.
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.
| Feb 18, 2021 | Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-ShapeK201863 · NEU | 510(k) clearances |
| Feb 3, 2021 | Thread-like wire markerClass II · This recall has been initiated due to the risk of wire splintering after contact with a cautery device during the remova | Device recalls |
| Oct 31, 2018 | Tumark for Eviva, Tumark for BreveraK182082 · NEU | 510(k) clearances |
| Mar 22, 2018 | Tumark VisionK180443 · NEU | 510(k) clearances |
| Nov 8, 2011 | TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATECK111692 · NEU | 510(k) clearances |
| Jun 24, 2011 | BIOPSY HANDY, MRI BIOPSY HANDYK102771 · KNW | 510(k) clearances |
| Feb 17, 2010 | TUMARK PROFESSIONAL, MODEL 271560, MR-TUMARK PROFESSIONAL, MODEL 601560K093064 · NEU | 510(k) clearances |
| Mar 19, 2008 | TUMARK PROFESSIONAL, MODEL 271560; MR- TUMARK PROFESSIONAL, MODEL 601560K073095 · NEU | 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
