Genesee Biomedical, Inc. - FDA 510(k) Cleared Devices

Cleared Jul 25, 2025

TransForm McCarthy Mitral Annuloplasty Ring (TF)

K250859 · KRH

Cardiovascular · 126d

Cleared Apr 09, 2024

TransForm McCarthy Mitral Annuloplasty Ring (TF)

K232599 · KRH

Cardiovascular · 225d

Cleared May 26, 2023

WellsForm Tricuspid Annuloplasty Band (WF)

K230679 · KRH

Cardiovascular · 74d

Cleared Oct 06, 2020

TruForm Sievers Annuloplasty Ring

K202253 · KRH

Cardiovascular · 57d

Cleared Apr 18, 2019

NeoForm Annuloplasty Ring

K190506 · KRH

Cardiovascular · 48d

Cleared Oct 12, 2016

FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band

K161815 · KRH

Cardiovascular · 103d

Cleared Jul 15, 2010

ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC

K093903 · KRH

Cardiovascular · 205d

Cleared May 07, 2009

ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY, MODEL 735 AC

K090428 · KRH

Cardiovascular · 77d

Cleared Feb 25, 2009

ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SC

K083683 · KRH

Cardiovascular · 75d

Cleared Oct 23, 2007

ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SR

K072655 · KRH

Cardiovascular · 33d

Cleared Jul 31, 2007

ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY RING

K071214 · KRH

Cardiovascular · 91d

Cleared Nov 17, 2005

ATS SIMULUS ANNULOPLASTY RING, MODEL 700FF

K052565 · KRH

Cardiovascular · 59d

Cleared Nov 17, 2005

ATS SIMULUS ANNULOPLASTY BAND, MODEL 700FC

K052899 · KRH

Cardiovascular · 34d