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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 2 of 4

Device	Model / Reference	Registries	Class	Status
Annular Sizer Aortic	ASR23/25	FDA UDI	Class I	Active
FlexForm Annuloplasty Ring	FRN-36	FDA UDI	Class II	Active
Coronary Artery Probe 2.00mm Long	CPH-2.00L	FDA UDI	Class I	Active
TruForm Annuloplasty Ring	TRH-26	FDA UDI	Class II	Active
FlexForm Annuloplasty Ring	FRN-26	FDA UDI	Class II	Active
Myocardial Needle Temperature Probe	XE2125	FDA UDI	Class II	Active
Pediatric Curved Sternal Retractor	PSRC-AR	FDA UDI	Class I	Active
Annular Sizer Aortic	ASR27/29	FDA UDI	Class I	Active
FlexForm Annuloplasty Band	FBH-30	FDA UDI	Class II	Active
TruForm Annuloplasty Ring	TRH-32	FDA UDI	Class II	Active
WellsFormTricuspid Annuloplasty Band	WF-32	FDA UDI	Class II	Active
Heart-Chill Cardiac & Phrenic Insulator	CPI-S	FDA UDI	Class II	Active
Neonatal Curved Sternal Retractor with Blades Only	NSR-1	FDA UDI	Class I	Active
FlexForm Annuloplasty Ring	FRN-38	FDA UDI	Class II	Active
FlexForm Annuloplasty Ring	FRN-32	FDA UDI	Class II	Active
FlexForm Annuloplasty Ring	FRN-28	FDA UDI	Class II	Active
FlexForm Annuloplasty Ring	FRH-30	FDA UDI	Class II	Active
Intra-Art Coronary Artery Retraction Clip	CRC-5	FDA UDI	Class I	Active
Anastomark Coronary Artery Bypass Graft Markers, Bulk Distal Marker Rings	AMGM-BD	FDA UDI	Class II	Active
Aortic Repair Caliper	ARC-8	FDA UDI	Class I	Active
FlexForm Annuloplasty Ring	FRN-30	FDA UDI	Class II	Active
Coronary Artery Probe 2.50mm	CPH-2.50	FDA UDI	Class I	Active
Coronary Artery Probe 3.00mm	CPH-3.00	FDA UDI	Class I	Active
FlexForm Annuloplasty Ring	FRH-32	FDA UDI	Class II	Active
Child Curved Sternal Retractor with Blades Only	CSR-AR	FDA UDI	Class I	Active
WellsForm Tricuspid Annuloplasty Band	WF-34	FDA UDI	Class II	Active
FlexForm Annuloplasty Ring	FRH-26	FDA UDI	Class II	Active
FlexForm Annuloplasty Ring	FRN-34	FDA UDI	Class II	Active
Coronary Artery Probe 2.75mm	CPH-2.75	FDA UDI	Class I	Active
FlexForm Annuloplasty Ring	FRH-38	FDA UDI	Class II	Active
AVATR Minimally Invasive Adult Retractor with atrial and aortic rakes	ATR-AR	FDA UDI	Class I	Active
Anastomark Coronary Artery Bypass Graft Markers, Stainless Steel, Proximal, Med	AMGM-PM	FDA UDI	Class II	Active
FlexForm Annuloplasty Ring	FRH-34	FDA UDI	Class II	Active
WellsForm Tricuspid Annuloplasty Band	WF-30	FDA UDI	Class II	Active
TransForm McCarthy Annuloplasty Ring	TF-26	FDA UDI	Class II	Active
Anastomark Coronary Artery Bypass Graft Markers, Flexible Proximal	FM-PM-3	FDA UDI	Class II	Active
FlexForm Annuloplasty Band	FBH-32	FDA UDI	Class II	Active
Myocardial Needle Temperature Probe	2423	FDA UDI	Class II	Active
TruForm Annuloplasty Ring	TRH-42	FDA UDI	Class II	Active
TransForm McCarthy Annuloplasty Ring	TF-36	FDA UDI	Class II	Active
Aortic Repair Caliper	ARC-6	FDA UDI	Class I	Active
WellsForm Tricuspid Annuloplasty Band	WF-36	FDA UDI	Class II	Active
TruForm Annuloplasty Ring	TRH-40	FDA UDI	Class II	Active
Myocardial Needle Temperature Probe	XE2126	FDA UDI	Class II	Active
Heart-Chill Cardiac & Phrenic Insulator	CPI-L	FDA UDI	Class II	Active
Robotic Tool Kit Large Diameter Suction	RTK-LDS	FDA UDI	Class I	Active
FlexForm Annuloplasty Band	FBH-28	FDA UDI	Class II	Active
TransForm McCarthy Annuloplasty Ring	TF-24	FDA UDI	Class II	Active
Coronary Artery Probe 1.75mm Long	CPH-1.75L	FDA UDI	Class I	Active
FlexForm Annuloplasty Band	FBN-38	FDA UDI	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.