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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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Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1000517719
DUNS Number: —

Catalogue (152)

Page 1 of 4

Device	Model / Reference	Registries	Class	Status
ATLAAS (Atraumatic Left Atrial Appendage System) (AD)	K252917	FDA 510(k)	Class II	Active
FlexForm Annuloplasty Band	FBN-32	FDA UDI	Class II	Active
Coronary Artery Probe 3.00mm Long	CPH-3.00L	FDA UDI	Class I	Active
Coronary Artery Probe 2.50mm Long	CPH-2.50L	FDA UDI	Class I	Active
FlexForm Annuloplasty Band	FBN-40	FDA UDI	Class II	Active
Intra-Art Coronary Artery Retraction Clip	CRC-3	FDA UDI	Class I	Active
Aortic Repair Caliper	ARC-10	FDA UDI	Class I	Active
MINIMAX Minimally Invasive Retractor	MMX-1RS	FDA UDI	Class I	Active
Coronary Artery Probe 1.50mm	CPH-1.50	FDA UDI	Class I	Active
Coronary Artery Probe 1mm	CPH-1.00	FDA UDI	Class I	Active
Aortic Repair Caliper	ARC-9	FDA UDI	Class I	Active
Robotic Tool Kit Knot Pusher Closed	RTK-RKP	FDA UDI	Class I	Active
WellsForm Tricuspid Annuloplasty Band	WF-28	FDA UDI	Class II	Active
FlexForm Annuloplasty Band	FBH-36	FDA UDI	Class II	Active
Myocardial Needle Temperature Probe	2124	FDA UDI	Class II	Active
Coronary Artery Probe 1.25mm	CPH-1.25	FDA UDI	Class I	Active
Universal Y Connector	WD-20	FDA UDI	Class II	Active
Coronary Artery Probe 1.25mm Long	CPH-1.25L	FDA UDI	Class I	Active
Aortic Repair Tool Kit	ART-2	FDA UDI	Class I	Active
TruForm Annuloplasty Ring	TRH-24	FDA UDI	Class II	Active
FlexForm Annuloplasty Band	FBN-26	FDA UDI	Class II	Active
Adult Curved Sternal Latch Retractor with Atrial and Aortic Rakes	SRCL-AR	FDA UDI	Class I	Active
Coronary Artery Probe 1.50mm Long	CPH-1.50L	FDA UDI	Class I	Active
Adult Curved Sternal Latch Retractor with Blades Only	SRCL-1	FDA UDI	Class I	Active
NeoForm	4200-32	FDA UDI	Class II	Active
Annular Sizer Aortic	ASR19/21	FDA UDI	Class I	Active
Anastomark Coronary Artery Bypass Graft Markers, Flexible Proximal	FM-PM-2	FDA UDI	Class II	Active
Coronary Artery Probe 1.75mm	CPH-1.75	FDA UDI	Class I	Active
TransForm McCarthy Annuloplasty Ring	TF-30	FDA UDI	Class II	Active
Aortic Repair Caliper	ARC-7	FDA UDI	Class I	Active
TruForm Annuloplasty Ring	TRH-36	FDA UDI	Class II	Active
FlexForm Annuloplasty Band	FBH-38	FDA UDI	Class II	Active
NeoForm	4200-28	FDA UDI	Class II	Active
Robotic Tool Kit Ball Tip Suction	RTK-BTS	FDA UDI	Class I	Active
FlexForm Annuloplasty Band	FBH-26	FDA UDI	Class II	Active
Myocardial Needle Temperature Probe	2426	FDA UDI	Class II	Active
Adult Curved Sternal Latch Retractor with Atrial and Aortic Rakes	SRLP-AR	FDA UDI	Class I	Active
TransForm McCarthy Annuloplasty Ring	TF-34	FDA UDI	Class II	Active
TruForm Annuloplasty Ring	TRH-30	FDA UDI	Class II	Active
FlexForm Annuloplasty Ring	FRH-24	FDA UDI	Class II	Active
Pediatric Curved Sternal Retractor	PSRC-1	FDA UDI	Class I	Active
FlexForm Annuloplasty Ring	FRH-28	FDA UDI	Class II	Active
AVATR Minimally Invasive Adult Retractor with Interchangeable Blades	ATR-1	FDA UDI	Class I	Active
Anastomark Coronary Artery Bypass Graft Markers, Stainless Steel, Distal	AMGM-D	FDA UDI	Class II	Active
Coronary Artery Probe 2.25mm	CPH-2.25	FDA UDI	Class I	Active
FlexForm Annuloplasty Ring	FRH-40	FDA UDI	Class II	Active
FlexForm Annuloplasty Ring	FRN-40	FDA UDI	Class II	Active
TransForm McCarthy Annuloplasty Ring	TF-40	FDA UDI	Class II	Active
Adult Curved Sternal Latch Retractor	SRLP-1	FDA UDI	Class I	Active
Myocardial Needle Temperature Probe	XE2425	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.