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GENESEE BIOMEDICAL, INC.

Last updated September 17, 2026

Information

Country: US
Address: 700 W Mississippi Ave Unit D5, DENVER, CO, 80223
Website: —
LinkedIn: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1000517719
DUNS Number: —

Catalogue (152)

Page 3 of 4

Device	Model / Reference	Registries	Class	Status
MINIMAX Minimally Invasive Retractor	MMX-1	FDA UDI	Class I	Active
TruForm Annuloplasty Ring	TRH-34	FDA UDI	Class II	Active
FlexForm Annuloplasty Band	FBH-24	FDA UDI	Class II	Active
Adult Curved Sternal Latch Retractor with Curved Atrial and Aortic Rakes	SRCL-ARC	FDA UDI	Class I	Active
NeoForm	4200-26	FDA UDI	Class II	Active
TransForm McCarthy Annuloplasty Ring	TF-32	FDA UDI	Class II	Active
Coronary Artery Probe 2.25mm Long	CPH-2.25L	FDA UDI	Class I	Active
FlexForm Annuloplasty Band	FBH-34	FDA UDI	Class II	Active
Neonatal Curved Sternal Retractor with Blades Only	NSR-AR	FDA UDI	Class I	Active
Myocardial Needle Temperature Probe	2424	FDA UDI	Class II	Active
TransForm McCarthy Annuloplasty Ring	TF-38	FDA UDI	Class II	Active
FlexForm Annuloplasty Band	FBN-28	FDA UDI	Class II	Active
TransForm McCarthy Annuloplasty Ring	TF-28	FDA UDI	Class II	Active
FlexForm Annuloplasty Band	FBN-36	FDA UDI	Class II	Active
Robotic Suture Hook Left	RSH-L	FDA UDI	Class I	Active
Coronary Artery Probe 2.75mm Long	CPH-2.75L	FDA UDI	Class I	Active
NeoForm	4200-30	FDA UDI	Class II	Active
Robotic Tool Kit Valve Sizer Stainless	RTK-VSS	FDA UDI	Class I	Active
FlexForm Annuloplasty Band	FBH-40	FDA UDI	Class II	Active
FlexForm Annuloplasty Ring	FRN-24	FDA UDI	Class II	Active
WellForm Tricuspid Annuloplasty Band	WF-26	FDA UDI	Class II	Active
Coronary Artery Probe 2.00mm	CPH-2.00	FDA UDI	Class I	Active
FlexForm Annuloplasty Ring	FRH-36	FDA UDI	Class II	Active
TruForm Annuloplasty Ring	TRH-38	FDA UDI	Class II	Active
FlexForm Annuloplasty Band	FBN-24	FDA UDI	Class II	Active
PhotoFix	PFP6x8	FDA UDI	Class II	Active
TruForm Annuloplasty Ring	TRH-28	FDA UDI	Class II	Active
FlexForm Annuloplasty Band	FBN-34	FDA UDI	Class II	Active
Myocardial Needle Temperature Probe	2123	FDA UDI	Class II	Active
FlexForm Annuloplasty Band	FBN-30	FDA UDI	Class II	Active
Anastomark Coronary Artery Bypass Graft Markers, Stainless Steel, Distal	AMGM-SD	FDA UDI	Class II	Active
Anastomark Coronary Artery Bypass Graft Markers, Flexible Proximal	FM-PM-1	FDA UDI	Class II	Active
Heart Chill Cardiac & Phrenic Insulator	CPI-M	FDA UDI	Class II	Active
Robotic Tool Kit Knot Pusher Open	RTK-KPO	FDA UDI	Class I	Active
MINIMAX Minimally Invasive Retractor	MMX-1R	FDA UDI	Class I	Active
Coronary Artery Probe 1.00mm Long	CPH-1.00L	FDA UDI	Class I	Active
Robotic Suture Hook Right	RSH-R	FDA UDI	Class I	Active
Child Curved Sternal Retractor with Blades Only	CSR-1	FDA UDI	Class I	Active
Annular Sizer Aortic	ASR-31/33	FDA UDI	Class I	Active
Ats Simulus Adjustable Flexible Annuloplasty Ring	K071214	FDA 510(k)	Class II	Active
TruForm Sievers Annuloplasty Ring	K202253	FDA 510(k)	Class II	Active
Ats Simulus Annuloplasty Band, Model 700fc	K052899	FDA 510(k)	Class II	Active
TransForm McCarthy Mitral Annuloplasty Ring (TF)	K232599	FDA 510(k)	Class II	Active
FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band	K161815	FDA 510(k)	Class II	Active
WellsForm Tricuspid Annuloplasty Band (WF)	K230679	FDA 510(k)	Class II	Active
Ats Tri-Ad Semi-Flexible Tricuspid Anuuloplasty, Model 900sfc	K093903	FDA 510(k)	Class II	Active
Ats Simulus Annuloplasty Ring, Model 700ff	K052565	FDA 510(k)	Class II	Active
Ats Simulus Adjustable Flexible Annuloplasty, Model 735 Ac	K090428	FDA 510(k)	Class II	Active
Ats Simulus Semi-Rigid Mitral Annuloplasty Ring, Model 800sc	K083683	FDA 510(k)	Class II	Active
TransForm McCarthy Mitral Annuloplasty Ring (TF)	K250859	FDA 510(k)	Class II	Active

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FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Feb 26, 2018	Z-1953-2018	—	open, classified	Failure in a retractor blade due to corrosion. In the area of the blade where the bearing/button meets the blade body, corrosion can form, weakening the welded joint and may cause the bearing/button to break.