Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Genesee BioMedical with 14 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated May 22, 2026: ATLAAS (Atraumatic Left Atrial Appendage System) (AD).
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 22, 2026 | ATLAAS (Atraumatic Left Atrial Appendage System) (AD)K252917 · PZX | 510(k) clearances |
| Jul 25, 2025 | TransForm McCarthy Mitral Annuloplasty Ring (TF)K250859 · KRH | 510(k) clearances |
| Apr 9, 2024 | TransForm McCarthy Mitral Annuloplasty Ring (TF)K232599 · KRH | 510(k) clearances |
| May 26, 2023 | WellsForm Tricuspid Annuloplasty Band (WF)K230679 · KRH | 510(k) clearances |
| Oct 6, 2020 | TruForm Sievers Annuloplasty RingK202253 · KRH | 510(k) clearances |
| Apr 18, 2019 | NeoForm Annuloplasty RingK190506 · KRH | 510(k) clearances |
| Feb 26, 2018 | Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR-1, ATR-AR, CSR-1 and CSR-AR. For use inClass II · Failure in a retractor blade due to corrosion. In the area of the blade where the bearing/button meets the blade body, c | Device recalls |
| Oct 12, 2016 | FlexForm Annuloplasty Ring and FlexForm Annuloplasty BandK161815 · KRH | 510(k) clearances |
| Jul 15, 2010 | ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFCK093903 · KRH | 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
