Genesee Biomedical, Inc.
Medical device manufacturer in Denver, CO.
14510(k) clearances
0PMA approvals
1recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K252917 | ATLAAS (Atraumatic Left Atrial Appendage System) (AD)PZX · Traditional | 05/22/2026SE |
| K250859 | TransForm McCarthy Mitral Annuloplasty Ring (TF)KRH · Traditional | 07/25/2025SE |
| K232599 | TransForm McCarthy Mitral Annuloplasty Ring (TF)KRH · Traditional | 04/09/2024SE |
| K230679 | WellsForm Tricuspid Annuloplasty Band (WF)KRH · Traditional | 05/26/2023SE |
| K202253 | TruForm Sievers Annuloplasty RingKRH · Traditional | 10/06/2020SE |
| K190506 | NeoForm Annuloplasty RingKRH · Traditional | 04/18/2019SE |
| K161815 | FlexForm Annuloplasty Ring and FlexForm Annuloplasty BandKRH · Traditional | 10/12/2016SE |
| K093903 | Ats Tri-Ad Semi-Flexible Tricuspid Anuuloplasty, Model 900SFCKRH · Special | 07/15/2010SE |
| K090428 | Ats Simulus Adjustable Flexible Annuloplasty, Model 735 AcKRH · Special | 05/07/2009SE |
| K083683 | Ats Simulus Semi-Rigid Mitral Annuloplasty Ring, Model 800SCKRH · Special | 02/25/2009SE |
| K072655 | Ats Simulus Semi-Rigid Mitral Annuloplasty Ring, Model 800SRKRH · Special | 10/23/2007SE |
| K071214 | Ats Simulus Adjustable Flexible Annuloplasty RingKRH · Special | 07/31/2007SE |
| K052899 | Ats Simulus Annuloplasty Band, Model 700FCKRH · Special | 11/17/2005SE |
| K052565 | Ats Simulus Annuloplasty Ring, Model 700FFKRH · Special | 11/17/2005SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1953-2018 Class II | Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1…Failure in a retractor blade due to corrosion. In the area of the blade where the bearing/button meets the… | 02/26/2018Open, Classified |