FDA.reportPublic FDA data

GENESEE BIOMEDICAL, INC.

Matched from indexed company URL: Genesee Biomedical, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
17232411000517719GENESEE BIOMEDICAL, INC.1N2026-01-01700 W Mississippi Ave Unit D5 DENVER CO US 80223

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
B040RPS181100Thoracic Port with Obturator 18x110mm - Thoracic Port with Obturator 18 mm ID x 110 mm Length1-800-786-4880cservice@geneseebiomedical.com
B040RPS18500Thoracic Port with Obturator 18x50mm - Thoracic Port with Obturator 18 mm ID x 50 mm Length1-800-786-4880cservice@geneseebiomedical.com
B040RPS18700Thoracic Port with Obturator 18x70mm - Thoracic Port with Obturator 18 mm ID x 70 mm Length1-800-786-4880cservice@geneseebiomedical.com
B040RPS18900Thoracic Port with Obturator 18x90mm - Thoracic Port with Obturator 18 mm ID x 90 mm Length1-800-786-4880cservice@geneseebiomedical.com
B040TF260TransForm McCarthy Annuloplasty Ring - Annuloplasty Ring800 786-4890info@geneseebiomedical.com
B040TF280TransForm McCarthy Annuloplasty Ring - Annuloplasty Ring800 786-4890info@geneseebiomedical.com
B040TF300TransForm McCarthy Annuloplasty Ring - Annuloplasty Ring800 786-4890info@geneseebiomedical.com
B040TF320TransForm McCarthy Annuloplasty Ring - Annuloplasty Ring800 786-4890info@geneseebiomedical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
502911850835523K905067PTI ANASTOMARK FLEXIBLE CORONARY BYPASS GRAFTDSY1991-03-18
502912053914802K901815MODIFIED STERILIZATION OF INTRA-ART(TM) CORONARYDRE1990-07-03
502911075870383K901531PTI INTRA-ARTR REUSABLE CORONARY ARTERY PROBEDNP1990-06-20
502911059227254K882981PTI INTRA-ART CORONARY ARTERY RETRACTION CLIPDWS1988-09-27
502911465730379K882381PTI HEART-LIFT(TM) CARDIAC RETRACTION GLOVES-STERIKGO1988-07-07
502911476763570K874927PTI HEART-CHILL(TM) CARDIAC INSULATING JACKETDWC1988-01-29
502911759538978K813459REUSABLE & DISPOSABLE TEMP. PROBESFLL1982-03-26
502911371392637K232599TransForm McCarthy Mitral Annuloplasty Ring (TF)KRH2024-04-09
502911506118529K230679WellsForm Tricuspid Annuloplasty Band (WF)KRH2023-05-26
502911152715265K202253TruForm Sievers Annuloplasty RingKRH2020-10-06
502911174674599K190506NeoForm Annuloplasty RingKRH2019-04-18
502911220805252K161815FlexForm Annuloplasty Ring and FlexForm Annuloplasty BandKRH2016-10-12
502911208782155
502911211006481
502911374884691
502911653436290
502911818896335
502911838579663
502911921130289

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KRH52024-04-09
DSY11991-03-18
DRE11990-07-03
DNP11990-06-20
DWS11988-09-27
KGO11988-07-07
DWC11988-01-29
FLL11982-03-26

PMN#

GUDID#

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