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 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Cousin Biotech with 8 510(k) clearances. The most recent is a 510(k) clearance dated Jan 9, 2019: Cortical Fixation Systems.
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.
| Jan 9, 2019 | Cortical Fixation SystemsK181086 · MBI | 510(k) clearances |
| Aug 29, 2018 | ResCUBE™ Ligament Fixation SystemK181799 · OWI | 510(k) clearances |
| Apr 10, 2018 | NAJA™ Ligament Correction SystemK172206 · OWI | 510(k) clearances |
| Sep 4, 2014 | PREMIUMK133889 · FTL | 510(k) clearances |
| Jun 25, 2010 | BIOMESH CA.B.S. 'AIR COMPOSITE, MODELS: CABST1R05T, CABSAIRC7, CABSAIRC09K093196 · FTL | 510(k) clearances |
| Jun 26, 2008 | CABS'AIRK072962 · FTL | 510(k) clearances |
| Aug 22, 2007 | 4DDOMEK070918 · FTL | 510(k) clearances |
| Oct 19, 2000 | BIOMESH P1 AND BIOMESH PLUG AND PATCHK002479 · FTL | 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