Genesee BioMedical, Inc.
Denver, CO, US
GENESEE BIOMEDICAL, INC. appears in FDA device records in Denver, CO. FDA records list 14 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 14 510(k) clearances for Genesee BioMedical, Inc. between 2005 and 2026. The busiest year on record is 2005, with 2. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 2 |
| 2007 | 2 |
| 2009 | 2 |
| 2010 | 1 |
| 2016 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252917 | ATLAAS (Atraumatic Left Atrial Appendage System) (AD) | PZX | Substantially Equivalent | |
| K250859 | TransForm McCarthy Mitral Annuloplasty Ring (TF) | KRH | Substantially Equivalent | |
| K232599 | TransForm McCarthy Mitral Annuloplasty Ring (TF) | KRH | Substantially Equivalent | |
| K230679 | WellsForm Tricuspid Annuloplasty Band (WF) | KRH | Substantially Equivalent | |
| K202253 | TruForm Sievers Annuloplasty Ring | KRH | Substantially Equivalent | |
| K190506 | NeoForm Annuloplasty Ring | KRH | Substantially Equivalent | |
| K161815 | FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band | KRH | Substantially Equivalent | |
| K093903 | ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC | KRH | Substantially Equivalent | |
| K090428 | ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY, MODEL 735 AC | KRH | Substantially Equivalent | |
| K083683 | ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SC | KRH | Substantially Equivalent | |
| K072655 | ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SR | KRH | Substantially Equivalent | |
| K071214 | ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY RING | KRH | Substantially Equivalent | |
| K052899 | ATS SIMULUS ANNULOPLASTY BAND, MODEL 700FC | KRH | Substantially Equivalent | |
| K052565 | ATS SIMULUS ANNULOPLASTY RING, MODEL 700FF | KRH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1723241 | 1000517719 | GENESEE BIOMEDICAL, INC. | 700 W Mississippi Ave Unit D5, DENVER, CO 80223 US | 2026 | and 3 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KGZAccessories, Catheter
- KDQBottle, Collection, Vacuum
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- FLLContinuous Measurement Thermometer
- DWCController, Temperature, Cardiopulmonary Bypass
- DWSInstruments, Surgical, Cardiovascular
- PZXLeft Atrial Appendage Clip, Implantable
- DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter
- GADRetractor
- KRHRing, Annuloplasty
- FPASet, Administration, Intravascular
- DTISizer, Heart-Valve, Prosthesis
- MWSStabilizer, Heart
- DNPThin Layer Chromatography, Ethosuximide
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1953-2018 | 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 in cardiac surgery. | Failure in a retractor blade due to corrosion. In the area of the blade where the bearing/button meets the blade body, corrosion can form, weakening the welded joint and may cause the bearing/button to break. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain