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Genesee Biomedical, Inc.

FDA 510(k) & PMA Approved Devices — 14 products

Total Devices14
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K252917 ATLAAS (Atraumatic Left Atrial Appendage System) (AD)PZX2026-05-22 View
510(k) K250859 TransForm McCarthy Mitral Annuloplasty Ring (TF)KRH2025-07-25 View
510(k) K232599 TransForm McCarthy Mitral Annuloplasty Ring (TF)KRH2024-04-09 View
510(k) K230679 WellsForm Tricuspid Annuloplasty Band (WF)KRH2023-05-26 View
510(k) K202253 TruForm Sievers Annuloplasty RingKRH2020-10-06 View
510(k) K190506 NeoForm Annuloplasty RingKRH2019-04-18 View
510(k) K161815 FlexForm Annuloplasty Ring and FlexForm Annuloplasty BandKRH2016-10-12 View
510(k) K093903 ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFCKRH2010-07-15 View
510(k) K090428 ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY, MODEL 735 ACKRH2009-05-07 View
510(k) K083683 ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SCKRH2009-02-25 View
510(k) K072655 ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SRKRH2007-10-23 View
510(k) K071214 ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY RINGKRH2007-07-31 View
510(k) K052565 ATS SIMULUS ANNULOPLASTY RING, MODEL 700FFKRH2005-11-17 View
510(k) K052899 ATS SIMULUS ANNULOPLASTY BAND, MODEL 700FCKRH2005-11-17 View
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