Data / Medical devices / United States / Genesee Biomedical, Inc.

Genesee Biomedical, Inc.: FDA-registered device maker in Denver, CO, United States, 10 510(k) clearances

Name: Genesee Biomedical, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Genesee Biomedical, Inc. is registered with the FDA (registration 1723241) in Denver, CO, United States. It lists 13 device types. The FDA files 10 510(k) clearances under its listings, the newest dated April 9, 2024. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1723241
FEI number: 1000517719
Address: 700 W Mississippi Ave Unit D5, Denver, CO, United States, 80223
Owner or operator: GENESEE BIOMEDICAL, INC. (9012312)
Roles: Contract manufacturer, Manufacturer, Specification developer
First device listed: April 19, 1995
Registered through: 2026
Brand names listed: ANASTOSURE (TM), ANNULOPLASTY RING SIZER, AVATR Adult Thoracic Retractor, Adult Curved Sternal Retractor, Anastomark Coronary Graft Marker, Aortic Valve Repair Tool Kit, Cardiac Insulation Pads, Cardiac Insulator and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Catheter	KGZ	1	Manufacturer, Specification developer	accessdata.fda.gov
Bottle, Collection, Vacuum	KDQ	2	Manufacturer	accessdata.fda.gov
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	DWF	2	Contract manufacturer	accessdata.fda.gov
Continuous Measurement Thermometer	FLL	2	Manufacturer	accessdata.fda.gov
Controller, Temperature, Cardiopulmonary Bypass	DWC	2	Contract manufacturer, Manufacturer, Specification developer	accessdata.fda.gov
Instruments, Surgical, Cardiovascular	DWS	1	Manufacturer	accessdata.fda.gov
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter	DSY	2	Manufacturer, Specification developer	accessdata.fda.gov
Retractor	GAD	1	Manufacturer	accessdata.fda.gov
Ring, Annuloplasty	KRH	2	Manufacturer	accessdata.fda.gov
Set, Administration, Intravascular	FPA	2	Manufacturer, Specification developer	accessdata.fda.gov
Sizer, Heart-Valve, Prosthesis	DTI	1	Manufacturer, Specification developer	accessdata.fda.gov
Stabilizer, Heart	MWS	1	Manufacturer	accessdata.fda.gov
Thin Layer Chromatography, Ethosuximide	DNP	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 9, 2024	K232599	TransForm McCarthy Mitral Annuloplasty Ring (TF)	KRH	Substantially Equivalent	Genesee Biomedical, Inc.	accessdata.fda.gov
May 26, 2023	K230679	WellsForm Tricuspid Annuloplasty Band (WF)	KRH	Substantially Equivalent	Genesee Biomedical, Inc.	accessdata.fda.gov
October 6, 2020	K202253	TruForm Sievers Annuloplasty Ring	KRH	Substantially Equivalent	Genesee Biomedical, Inc.	accessdata.fda.gov
April 18, 2019	K190506	NeoForm Annuloplasty Ring	KRH	Substantially Equivalent	Genesee Biomedical, Inc.	accessdata.fda.gov
October 12, 2016	K161815	FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band	KRH	Substantially Equivalent	Genesee Biomedical, Inc.	accessdata.fda.gov
March 18, 1991	K905067	PTI ANASTOMARK FLEXIBLE CORONARY BYPASS GRAFT	DSY	Substantially Equivalent	Pioneering Technologies, Inc.	accessdata.fda.gov
June 20, 1990	K901531	PTI INTRA-ARTR REUSABLE CORONARY ARTERY PROBE	DNP	Substantially Equivalent	Pioneering Technologies, Inc.	accessdata.fda.gov
September 27, 1988	K882981	PTI INTRA-ART CORONARY ARTERY RETRACTION CLIP	DWS	Substantially Equivalent	Pioneering Technologies, Inc.	accessdata.fda.gov
January 29, 1988	K874927	PTI HEART-CHILL(TM) CARDIAC INSULATING JACKET	DWC	Substantially Equivalent	Pioneering Technologies, Inc.	accessdata.fda.gov
March 26, 1982	K813459	REUSABLE & DISPOSABLE TEMP. PROBES	FLL	Substantially Equivalent	Electromedics, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
February 26, 2018	80024	Class II	Ongoing	Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR-1, ATR-AR, CSR-1 and CSR-AR. For use in cardiac surgery.	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.	accessdata.fda.gov

Compare with other makers

Updated April 9, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.