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Genesee Biomedical, Inc.

FDA 510(k) & PMA Approved Devices — 6 products

Total Devices6
Categories1
Latest Approval2025-07-25
TypeNumberDevice NameCodeDate
510(k) K250859 TransForm McCarthy Mitral Annuloplasty Ring (TF) KRH 2025-07-25 View
510(k) K232599 TransForm McCarthy Mitral Annuloplasty Ring (TF) KRH 2024-04-09 View
510(k) K230679 WellsForm Tricuspid Annuloplasty Band (WF) KRH 2023-05-26 View
510(k) K202253 TruForm Sievers Annuloplasty Ring KRH 2020-10-06 View
510(k) K190506 NeoForm Annuloplasty Ring KRH 2019-04-18 View
510(k) K161815 FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band KRH 2016-10-12 View