Genesee Biomedical, Inc. - FDA 510(k) Cleared Devices
Recent clearances: ATLAAS (Atraumatic Left Atrial Appendage System) (AD), TransForm McCarthy Mitral Annuloplasty Ring (TF), TransForm McCarthy Mitral Annuloplasty Ring (TF)
14
Total
14
Cleared
0
Denied
FDA 510(k) Regulatory Record - Genesee Biomedical, Inc. Cardiovascular ✕
14 devices
Cleared
May 22, 2026
ATLAAS (Atraumatic Left Atrial Appendage System) (AD)
Cardiovascular
252d
Cleared
Jul 25, 2025
TransForm McCarthy Mitral Annuloplasty Ring (TF)
Cardiovascular
126d
Cleared
Apr 09, 2024
TransForm McCarthy Mitral Annuloplasty Ring (TF)
Cardiovascular
225d
Cleared
May 26, 2023
WellsForm Tricuspid Annuloplasty Band (WF)
Cardiovascular
74d
Cleared
Oct 06, 2020
TruForm Sievers Annuloplasty Ring
Cardiovascular
57d
Cleared
Apr 18, 2019
NeoForm Annuloplasty Ring
Cardiovascular
48d
Cleared
Oct 12, 2016
FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band
Cardiovascular
103d
Cleared
Jul 15, 2010
ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC
Cardiovascular
205d
Cleared
May 07, 2009
ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY, MODEL 735 AC
Cardiovascular
77d
Cleared
Feb 25, 2009
ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SC
Cardiovascular
75d
Cleared
Oct 23, 2007
ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SR
Cardiovascular
33d
Cleared
Jul 31, 2007
ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY RING
Cardiovascular
91d