Genesee Biomedical Inc

FDA Filings

This page includes the latest FDA filings for Genesee Biomedical Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 1723241
• FEI Number: 1000517719
• Name: GENESEE BIOMEDICAL, INC.
• Owner & Operator: GENESEE BIOMEDICAL, INC.
• Contact Address: 700 W Mississippi Ave Unit D-5; Denver CO 80223 US
• Official Correspondent:
  • WOODY MATHISON
  • x-303-7773000-103
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 700 W Mississippi Ave Unit D5 ; DENVER, CO 80223 US
• Establishment Type:
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
GUDID B040WF360 GENESEE BIOMEDICAL, INC.	WellsForm Tricuspid Annuloplasty Band	2023-10-10
GUDID B040WF34 GENESEE BIOMEDICAL, INC.	WellsForm Tricuspid Annuloplasty Band	2023-10-10
GUDID B040WF32 GENESEE BIOMEDICAL, INC.	WellsFormTricuspid Annuloplasty Band	2023-10-10
GUDID B040WF30 GENESEE BIOMEDICAL, INC.	WellsForm Tricuspid Annuloplasty Band	2023-10-10
GUDID B040WF28 GENESEE BIOMEDICAL, INC.	WellsForm Tricuspid Annuloplasty Band	2023-10-10
GUDID B040WF26 GENESEE BIOMEDICAL, INC.	WellForm Tricuspid Annuloplasty Band	2023-10-10
FPA GENESEE BIOMEDICAL, INC.	SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD)	2020-03-18
FPA GENESEE BIOMEDICAL, INC.	LIPO-PORT	2020-03-18
GUDID B040420032 GENESEE BIOMEDICAL, INC.	NeoForm	2019-05-30
GUDID B040420030 GENESEE BIOMEDICAL, INC.	NeoForm	2019-05-30
GUDID B040420028 GENESEE BIOMEDICAL, INC.	NeoForm	2019-05-30
GUDID B0404200260 GENESEE BIOMEDICAL, INC.	NeoForm	2019-05-30
PMN K190506 | KRH GENESEE BIOMEDICAL, INC.	NeoForm Annuloplasty Ring	2019-05-20
PMN K190506 Genesee BioMedical, Inc	NeoForm Annuloplasty Ring	2019-04-18
GUDID B040WD202J GENESEE BIOMEDICAL, INC.	Universal Y Connector	2019-02-07
GUDID B040XE24252W GENESEE BIOMEDICAL, INC.	Myocardial Needle Temperature Probe	2018-07-06
GUDID B040XE21262U GENESEE BIOMEDICAL, INC.	Myocardial Needle Temperature Probe	2018-07-06
GUDID B040XE21252T GENESEE BIOMEDICAL, INC.	Myocardial Needle Temperature Probe	2018-07-06
GUDID B040FRN40 GENESEE BIOMEDICAL, INC.	FlexForm Annuloplasty Ring	2018-07-06
GUDID B040FRN38 GENESEE BIOMEDICAL, INC.	FlexForm Annuloplasty Ring	2018-07-06
GUDID B040FRN36 GENESEE BIOMEDICAL, INC.	FlexForm Annuloplasty Ring	2018-07-06
GUDID B040FRN32 GENESEE BIOMEDICAL, INC.	FlexForm Annuloplasty Ring	2018-07-06
GUDID B040FRN30 GENESEE BIOMEDICAL, INC.	FlexForm Annuloplasty Ring	2018-07-06
GUDID B040FRN28 GENESEE BIOMEDICAL, INC.	FlexForm Annuloplasty Ring	2018-07-06
GUDID B040FRN26 GENESEE BIOMEDICAL, INC.	FlexForm Annuloplasty Ring	2018-07-06
GUDID B040FRN240 GENESEE BIOMEDICAL, INC.	FlexForm Annuloplasty Ring	2018-07-06
GUDID B040FRH40 GENESEE BIOMEDICAL, INC.	FlexForm Annuloplasty Ring	2018-07-06
GUDID B040FRH38 GENESEE BIOMEDICAL, INC.	FlexForm Annuloplasty Ring	2018-07-06
GUDID B040FRH36 GENESEE BIOMEDICAL, INC.	FlexForm Annuloplasty Ring	2018-07-06
GUDID B040FRH34 GENESEE BIOMEDICAL, INC.	FlexForm Annuloplasty Ring	2018-07-06
GUDID B040FRH32 GENESEE BIOMEDICAL, INC.	FlexForm Annuloplasty Ring	2018-07-06
GUDID B040FRH30 GENESEE BIOMEDICAL, INC.	FlexForm Annuloplasty Ring	2018-07-06
GUDID B040FRH28 GENESEE BIOMEDICAL, INC.	FlexForm Annuloplasty Ring	2018-07-06
GUDID B040FRH26 GENESEE BIOMEDICAL, INC.	FlexForm Annuloplasty Ring	2018-07-06
GUDID B040FRH24 GENESEE BIOMEDICAL, INC.	FlexForm Annuloplasty Ring	2018-07-06
GUDID B040FMPM32 GENESEE BIOMEDICAL, INC.	Anastomark Coronary Artery Bypass Graft Markers, F	2018-07-06
GUDID B040FMPM22 GENESEE BIOMEDICAL, INC.	Anastomark Coronary Artery Bypass Graft Markers, F	2018-07-06
GUDID B040FMPM12 GENESEE BIOMEDICAL, INC.	Anastomark Coronary Artery Bypass Graft Markers, F	2018-07-06
GUDID B040FBN40 GENESEE BIOMEDICAL, INC.	FlexForm Annuloplasty Band	2018-07-06
GUDID B040FBN38 GENESEE BIOMEDICAL, INC.	FlexForm Annuloplasty Band	2018-07-06
GUDID B040FBN36 GENESEE BIOMEDICAL, INC.	FlexForm Annuloplasty Band	2018-07-06
GUDID B040FBN34 GENESEE BIOMEDICAL, INC.	FlexForm Annuloplasty Band	2018-07-06
GUDID B040FBN320 GENESEE BIOMEDICAL, INC.	FlexForm Annuloplasty Band	2018-07-06
GUDID B040FBN30 GENESEE BIOMEDICAL, INC.	FlexForm Annuloplasty Band	2018-07-06
GUDID B040FBN28 GENESEE BIOMEDICAL, INC.	FlexForm Annuloplasty Band	2018-07-06
GUDID B040FBN26 GENESEE BIOMEDICAL, INC.	FlexForm Annuloplasty Band	2018-07-06
GUDID B040FBN24 GENESEE BIOMEDICAL, INC.	FlexForm Annuloplasty Band	2018-07-06
GUDID B040FBH40 GENESEE BIOMEDICAL, INC.	FlexForm Annuloplasty Band	2018-07-06
GUDID B040FBH38 GENESEE BIOMEDICAL, INC.	FlexForm Annuloplasty Band	2018-07-06
GUDID B040FBH36 GENESEE BIOMEDICAL, INC.	FlexForm Annuloplasty Band	2018-07-06
GUDID B040FBH34 GENESEE BIOMEDICAL, INC.	FlexForm Annuloplasty Band	2018-07-06
GUDID B040FBH32 GENESEE BIOMEDICAL, INC.	FlexForm Annuloplasty Band	2018-07-06
GUDID B040FBH30 GENESEE BIOMEDICAL, INC.	FlexForm Annuloplasty Band	2018-07-06
GUDID B040FBH28 GENESEE BIOMEDICAL, INC.	FlexForm Annuloplasty Band	2018-07-06
GUDID B040FBH26 GENESEE BIOMEDICAL, INC.	FlexForm Annuloplasty Band	2018-07-06
GUDID B040FBH24 GENESEE BIOMEDICAL, INC.	FlexForm Annuloplasty Band	2018-07-06
GUDID B040CRC52 GENESEE BIOMEDICAL, INC.	Intra-Art Coronary Artery Retraction Clip	2018-07-06
GUDID B040CRC32 GENESEE BIOMEDICAL, INC.	Intra-Art Coronary Artery Retraction Clip	2018-07-06
GUDID B040CPIS1 GENESEE BIOMEDICAL, INC.	Heart-Chill Cardiac & Phrenic Insulator	2018-07-06
GUDID B040CPIM26 GENESEE BIOMEDICAL, INC.	Heart Chill Cardiac & Phrenic Insulator	2018-07-06
GUDID B040CPIL25 GENESEE BIOMEDICAL, INC.	Heart-Chill Cardiac & Phrenic Insulator	2018-07-06
GUDID B04024262T GENESEE BIOMEDICAL, INC.	Myocardial Needle Temperature Probe	2018-07-06
GUDID B04024242R GENESEE BIOMEDICAL, INC.	Myocardial Needle Temperature Probe	2018-07-06
GUDID B04024232Q GENESEE BIOMEDICAL, INC.	Myocardial Needle Temperature Probe	2018-07-06
GUDID B04021242O GENESEE BIOMEDICAL, INC.	Myocardial Needle Temperature Probe	2018-07-06
GUDID B04021232N GENESEE BIOMEDICAL, INC.	Myocardial Needle Temperature Probe	2018-07-06
GUDID B0040FRN34 GENESEE BIOMEDICAL, INC.	FlexForm Annuloplasty Ring	2018-07-06
GUDID B040PFP6X81 GENESEE BIOMEDICAL, INC.	PhotoFix N/A	2018-03-29
GUDID B040AMGMSD2 GENESEE BIOMEDICAL, INC.	Anastomark Coronary Artery Bypass Graft Markers, S	2018-03-29
GUDID B040AMGMPM2 GENESEE BIOMEDICAL, INC.	Anastomark Coronary Artery Bypass Graft Markers, S	2018-03-29
GUDID B040AMGMD1 GENESEE BIOMEDICAL, INC.	Anastomark Coronary Artery Bypass Graft Markers, S	2018-03-29
GUDID B040AMGMBD1 GENESEE BIOMEDICAL, INC.	Anastomark Coronary Artery Bypass Graft Markers, B	2018-03-29
PMN K781990 | DWF GENESEE BIOMEDICAL, INC.	Cardiac Insulation Pads	2017-06-27
PMN K882981 | DWS GENESEE BIOMEDICAL, INC.	Intra-Art Coronary Artery Retraction Clip, 3mm or 5mm	2017-01-12
PMN K161815 | KRH GENESEE BIOMEDICAL, INC.	FlexForm Annuloplasty Ring & FlexForm Annuloplasty Band	2017-01-12
PMN K161815 Genesee BioMedical, Inc.	FlexForm Annuloplasty Ring And FlexForm Annuloplasty Band	2016-10-12
PMN K882381 | KGO GENESEE BIOMEDICAL, INC.	Heart Lift Cardiac Retraction Gloves	2015-09-03
PMN K093903 Genesee BioMedical, Inc.	ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC	2010-07-15
PMN K090428 Genesee BioMedical, Inc.	ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY, MODEL 735 AC	2009-05-07
PMN K083683 Genesee BioMedical, Inc.	ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SC	2009-02-25
PMN K905067 | DSY GENESEE BIOMEDICAL, INC.	Anastomark Coronary Graft Marker	2007-12-21
PMN K901815 | DRE GENESEE BIOMEDICAL, INC.	Intra-Art Coronary Occluder	2007-12-21
PMN K874927 | DWC GENESEE BIOMEDICAL, INC.	Cardiac Insulator	2007-12-21
PMN K813459 | FLL GENESEE BIOMEDICAL, INC.	Myocardial Temperature Probe	2007-12-21
PMN K072655 Genesee BioMedical, Inc.	ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SR	2007-10-23
PMN K071214 Genesee BioMedical, Inc.	ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY RING	2007-07-31
DTI GENESEE BIOMEDICAL, INC.	ANNULOPLASTY RING SIZER	2006-11-16
PMN K052899 Genesee BioMedical, Inc.	ATS SIMULUS ANNULOPLASTY BAND, MODEL 700FC	2005-11-17
PMN K052565 Genesee BioMedical, Inc.	ATS SIMULUS ANNULOPLASTY RING, MODEL 700FF	2005-11-17
KGZ GENESEE BIOMEDICAL, INC.	SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD)	2005-04-07
KGZ GENESEE BIOMEDICAL, INC.	LIPO-PORT	2005-04-07
MWS GENESEE BIOMEDICAL, INC.	LOC NESS (R)	2003-09-03
MWS GENESEE BIOMEDICAL, INC.	ANASTOSURE (TM)	2003-09-03
KDQ GENESEE BIOMEDICAL, INC.	GENESEE UNIVERSAL "Y" CONNECTOR	2000-04-18
DWS GENESEE BIOMEDICAL, INC.	HEART-LIFT CARDIAC RETRACTION SLING	1995-04-19

Related Finance Registrations

NCAGE Code	1RH85	GENESEE BIOMEDICAL, INC.
CAGE Code	1RH85	GENESEE BIOMEDICAL, INC.