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Data / Medical devices / Canada / HANSAmed Limited DBA Citagenix

HANSAmed Limited DBA Citagenix: FDA-registered device maker in Mississauga Ontario, Canada, 18 510(k) clearances

HANSAmed Limited DBA Citagenix is registered with the FDA (registration 3004431266) in Mississauga Ontario, Canada. It lists 18 device types. The FDA files 18 510(k) clearances under its listings, the newest dated July 24, 2024. Registered through 2026. FDA data exported November 3, 2026.

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Get makers like this oneWatch HANSAmed Limited DBA Citagenix
FDA registration number
3004431266
Address
2830 Argentia Rd Units 7-9, Mississauga Ontario, Canada, L5N 8G4
Owner or operator
HANSAMED LIMITED dba CITAGENIX (9076685)
Roles
Exporter to the US, Foreign private label distributor
First device listed
November 14, 2011
Registered through
2026
Brand names listed
Biotex, C-Blast Putty, C-Graft Putty, CevOss, Citagenix, DynaBlast, DynaGraft-D, Eclipse and more

Devices it lists

DeviceProduct codeClassRoleSource
Barrier, Animal Source, IntraoralNPL2Exporter to the US, Foreign private label distributoraccessdata.fda.gov
Barrier, Synthetic, IntraoralNPK2Exporter to the USaccessdata.fda.gov
Bit, DrillHTW1Exporter to the USaccessdata.fda.gov
Bone Grafting Material, Animal SourceNPM2Exporter to the US, Foreign private label distributoraccessdata.fda.gov
Bone Grafting Material, Human SourceNUN2Exporter to the USaccessdata.fda.gov
Bone Grafting Material, SyntheticLYC2Exporter to the US, Foreign private label distributoraccessdata.fda.gov
Handpiece, Direct Drive, Ac-PoweredEKX1Exporter to the USaccessdata.fda.gov
Implant, Endosseous, Root-FormDZE2Exporter to the USaccessdata.fda.gov
Plate, BoneJEY2Exporter to the USaccessdata.fda.gov
Scalpel, One-PieceGDX1Exporter to the USaccessdata.fda.gov
Screw, Fixation, BoneHWC2Exporter to the USaccessdata.fda.gov
Screw, Fixation, IntraosseousDZL2Exporter to the USaccessdata.fda.gov
ScrewdriverHXX1Exporter to the USaccessdata.fda.gov
Suture, Absorbable, Synthetic, Polyglycolic AcidGAM2Exporter to the USaccessdata.fda.gov
Suture, Surgical, Nonabsorbable, Expanded, PolytetraflouroethyleneNBY2Exporter to the USaccessdata.fda.gov
Syringe, PistonFMF2Exporter to the USaccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Exporter to the USaccessdata.fda.gov
Wound Dressing With Animal-Derived Material(S)KGNUForeign private label distributoraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
July 24, 2024K230305THE Graft CollagenNPMSubstantially EquivalentPurgo Biologics, Inc.accessdata.fda.gov
October 6, 2023K230091THE CoverNPLSubstantially EquivalentPurgo Biologics, Inc.accessdata.fda.gov
May 11, 2023K222549OpenTexNPKSubstantially EquivalentPurgo Biologics, Inc.accessdata.fda.gov
July 16, 2019K180992BiotexNBYSubstantially EquivalentPurgo Biologics, Inc.accessdata.fda.gov
July 20, 2018K173188The Graft Natural Bone SubstituteNPMSubstantially EquivalentPurgo Biologics, Inc.accessdata.fda.gov
January 7, 2016K143445Tellos ISQ BuddyEKXSubstantially EquivalentTellos Medical ABaccessdata.fda.gov
November 2, 2015K143584PGA RESORBA, PGA RESOQUICK, GLYCOLONGAMSubstantially EquivalentResorba Medical GmbHaccessdata.fda.gov
May 22, 2014K123876SYNERGYNPMSubstantially EquivalentOdontit S.A.accessdata.fda.gov
January 10, 2014K130235SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTYNUNSubstantially EquivalentHans Biomed Corp.accessdata.fda.gov
March 15, 2010K093122MBCP+LYCSubstantially EquivalentBiomatlanteaccessdata.fda.gov
November 13, 2009K091686LEFORTE NEUROSYSTEM BONE SCREWHWCSubstantially EquivalentJeil Medical Corporationaccessdata.fda.gov
October 2, 2009K091679LEFORTE SYSTEM BONE PLATEJEYSubstantially EquivalentJeil Medical Corporationaccessdata.fda.gov
March 29, 2006K060332ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTYNUNSubstantially EquivalentIsotis NVaccessdata.fda.gov
July 29, 2005K043573DYNAGRAFT II DENTALNUNSubstantially EquivalentIsotis Orthobiologics, Inc.accessdata.fda.gov
May 26, 2005K050669JEIL BONE FIXATION SYSTEMJEYSubstantially EquivalentJeil Medical Corporationaccessdata.fda.gov
February 24, 2004K033767DUAL TOP ANCHOR SYSTEM SCREWSDZESubstantially EquivalentJeil Medical Corporationaccessdata.fda.gov
September 9, 1992K923689SURGISTAR BLADESGDXSubstantially EquivalentSurgistar, Inc.accessdata.fda.gov
April 23, 1986K861153DISPOSABLE SYRINGES AND HYPODERMIC NEEDLESFMFSubstantially EquivalentExel Intl.accessdata.fda.gov

Compare with other makers

Updated July 24, 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.