Medical Device Manufacturer · US , Denver , CO

Genesee Biomedical, Inc.

13 submissions · 13 cleared · Since 2005
13
Total
13
Cleared
0
Denied

Genesee Biomedical, Inc. — FDA 510(k) Submissions

Genesee Biomedical, Inc. has submitted 13 FDA 510(k) premarket notifications since 2005, of which 13 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Ring, Annuloplasty . Use the specialty filter in the sidebar to narrow results.

13 devices
1–13 of 13
TransForm McCarthy Mitral Annuloplasty Ring (TF)
K250859 · KRH Ring, Annuloplasty · Cardiovascular
Jul 2025 126d
TransForm McCarthy Mitral Annuloplasty Ring (TF)
K232599 · KRH Ring, Annuloplasty · Cardiovascular
Apr 2024 225d
WellsForm Tricuspid Annuloplasty Band (WF)
K230679 · KRH Ring, Annuloplasty · Cardiovascular
May 2023 74d
TruForm Sievers Annuloplasty Ring
K202253 · KRH Ring, Annuloplasty · Cardiovascular
Oct 2020 57d
NeoForm Annuloplasty Ring
K190506 · KRH Ring, Annuloplasty · Cardiovascular
Apr 2019 48d
FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band
K161815 · KRH Ring, Annuloplasty · Cardiovascular
Oct 2016 103d
ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC
K093903 · KRH Ring, Annuloplasty · Cardiovascular
Jul 2010 205d
ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY, MODEL 735 AC
K090428 · KRH Ring, Annuloplasty · Cardiovascular
May 2009 77d
ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SC
K083683 · KRH Ring, Annuloplasty · Cardiovascular
Feb 2009 75d
ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SR
K072655 · KRH Ring, Annuloplasty · Cardiovascular
Oct 2007 33d
ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY RING
K071214 · KRH Ring, Annuloplasty · Cardiovascular
Jul 2007 91d
ATS SIMULUS ANNULOPLASTY RING, MODEL 700FF
K052565 · KRH Ring, Annuloplasty · Cardiovascular
Nov 2005 59d
ATS SIMULUS ANNULOPLASTY BAND, MODEL 700FC
K052899 · KRH Ring, Annuloplasty · Cardiovascular
Nov 2005 34d
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