Genesee BioMedical, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 13
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1953-2018 | Class II | Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR- | February 26, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K250859 | TransForm McCarthy Mitral Annuloplasty Ring (TF) | July 25, 2025 |
| K232599 | TransForm McCarthy Mitral Annuloplasty Ring (TF) | April 9, 2024 |
| K230679 | WellsForm Tricuspid Annuloplasty Band (WF) | May 26, 2023 |
| K202253 | TruForm Sievers Annuloplasty Ring | October 6, 2020 |
| K190506 | NeoForm Annuloplasty Ring | April 18, 2019 |
| K161815 | FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band | October 12, 2016 |
| K093903 | ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC | July 15, 2010 |
| K090428 | ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY, MODEL 735 AC | May 7, 2009 |
| K083683 | ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SC | February 25, 2009 |
| K072655 | ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SR | October 23, 2007 |
| K071214 | ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY RING | July 31, 2007 |
| K052899 | ATS SIMULUS ANNULOPLASTY BAND, MODEL 700FC | November 17, 2005 |
| K052565 | ATS SIMULUS ANNULOPLASTY RING, MODEL 700FF | November 17, 2005 |