Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Gunze LimitedLabelled 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 Kensey Nash with 32 510(k) clearances. The most recent is a 510(k) clearance dated May 9, 2018: DSM Biomedical Calcium Phosphate Cement with Microspheres.
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.
| May 9, 2018 | DSM Biomedical Calcium Phosphate Cement with MicrospheresK173572 · MQV | 510(k) clearances |
| Apr 3, 2018 | DSM Biomedical Calcium Phosphate CementK173362 · MQV | 510(k) clearances |
| May 16, 2017 | DSM Biomedical Dental Bone GraftK170245 · NPM | 510(k) clearances |
| Jun 7, 2016 | DSM Biomedical Porcine Pericardium Dental MembraneK160474 · NPL | 510(k) clearances |
| Feb 17, 2015 | MEDEOR MATRIX WOUND DRESSINGK141738 · KGN | 510(k) clearances |
| Dec 20, 2013 | MESO TENDON MATRIXK133169 · OWY | 510(k) clearances |
| Oct 30, 2013 | MESO BILAYER SURGICAL MESHK132025 · FTM | 510(k) clearances |
| Jul 11, 2013 | MESOTHELIUM DENTAL MEMBRANEK121310 · NPL | 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
