Genesee Biomedical, Inc.
FDA 510(k) & PMA Approved Devices — 7 products
Total Devices7
Categories2
Latest FDA decision2026-05-22
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K252917 | ATLAAS (Atraumatic Left Atrial Appendage System) (AD) | PZX | 2026-05-22 | View |
| 510(k) | K250859 | TransForm McCarthy Mitral Annuloplasty Ring (TF) | KRH | 2025-07-25 | View |
| 510(k) | K232599 | TransForm McCarthy Mitral Annuloplasty Ring (TF) | KRH | 2024-04-09 | View |
| 510(k) | K230679 | WellsForm Tricuspid Annuloplasty Band (WF) | KRH | 2023-05-26 | View |
| 510(k) | K202253 | TruForm Sievers Annuloplasty Ring | KRH | 2020-10-06 | View |
| 510(k) | K190506 | NeoForm Annuloplasty Ring | KRH | 2019-04-18 | View |
| 510(k) | K161815 | FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band | KRH | 2016-10-12 | View |
No matching devices.