Company ยท US
Genesee Biomedical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2026. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (1 in 12 months)
1recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 22, 2026 | K252917 | ATLAAS (Atraumatic Left Atrial Appendage System) (AD) Genesee Biomedical, Inc. | PZX |
| Jul 25, 2025 | K250859 | TransForm McCarthy Mitral Annuloplasty Ring (TF) Genesee Biomedical, Inc. | KRH |
| Apr 9, 2024 | K232599 | TransForm McCarthy Mitral Annuloplasty Ring (TF) Genesee Biomedical, Inc. | KRH |
| May 26, 2023 | K230679 | WellsForm Tricuspid Annuloplasty Band (WF) Genesee Biomedical, Inc. | KRH |
| Oct 6, 2020 | K202253 | TruForm Sievers Annuloplasty Ring Genesee Biomedical, Inc. | KRH |
| Apr 18, 2019 | K190506 | NeoForm Annuloplasty Ring Genesee Biomedical, Inc. | KRH |
| Oct 12, 2016 | K161815 | FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band Genesee Biomedical, Inc. | KRH |
| Jul 15, 2010 | K093903 | ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC Genesee Biomedical, Inc. | KRH |
| May 7, 2009 | K090428 | ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY, MODEL 735 AC Genesee Biomedical, Inc. | KRH |
| Feb 25, 2009 | K083683 | ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SC Genesee Biomedical, Inc. | KRH |
| Oct 23, 2007 | K072655 | ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SR Genesee Biomedical, Inc. | KRH |
| Jul 31, 2007 | K071214 | ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY RING Genesee Biomedical, Inc. | KRH |
| Nov 17, 2005 | K052899 | ATS SIMULUS ANNULOPLASTY BAND, MODEL 700FC Genesee Biomedical, Inc. | KRH |
| Nov 17, 2005 | K052565 | ATS SIMULUS ANNULOPLASTY RING, MODEL 700FF Genesee Biomedical, Inc. | KRH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 26, 2018 | Genesee BioMedical, Inc. 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 in cardiac surgery. Open, Classified |
DWS | None listed |