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Data / Medical devices / Canada / 15445361 Canada Inc.

15445361 Canada Inc.: FDA-registered device maker in Shawinigan Quebec, Canada, 17 510(k) clearances

15445361 Canada Inc. is registered with the FDA (registration 3043051314) in Shawinigan Quebec, Canada. It lists 36 device types. The FDA files 17 510(k) clearances under its listings, the newest dated March 24, 2023. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch 15445361 Canada Inc.
FDA registration number
3043051314
Address
460 203e Rue, Shawinigan Quebec, Canada, G9T 6R5
Owner or operator
15445361 Canada Inc. (10094832)
Roles
Exporter to the US
First device listed
December 26, 2025
Registered through
2026

Devices it lists

DeviceProduct codeClassRoleSource
Accessory, Surgical ApparelLYU1Exporter to the USaccessdata.fda.gov
Applicator, Absorbent Tipped, Non-SterileKXF1Exporter to the USaccessdata.fda.gov
Bandage, ElasticFQM1Exporter to the USaccessdata.fda.gov
Cannula, Surgical, General & Plastic SurgeryGEA1Exporter to the USaccessdata.fda.gov
Cap, SurgicalFYF1Exporter to the USaccessdata.fda.gov
Catheter, Retention Type, BalloonEZL2Exporter to the USaccessdata.fda.gov
Collector, Urine, (And Accessories) For Indwelling CatheterKNX2Exporter to the USaccessdata.fda.gov
Container, Liquid Medication, GraduatedKYW1Exporter to the USaccessdata.fda.gov
Device, Transfer, Patient, ManualFMR1Exporter to the USaccessdata.fda.gov
Drape, Surgical, ExemptPUI2Exporter to the USaccessdata.fda.gov
Dressing, CompressionMHW1Exporter to the USaccessdata.fda.gov
Dressing, Wound, DrugFROUExporter to the USaccessdata.fda.gov
Dressing, Wound, OcclusiveNAD1Exporter to the USaccessdata.fda.gov
Electrode, ElectrocardiographDRX2Exporter to the USaccessdata.fda.gov
EsthesiometerGXB1Exporter to the USaccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Exporter to the USaccessdata.fda.gov
Latex Patient Examination GloveLYY1Exporter to the USaccessdata.fda.gov
Lubricant, PatientKMJ1Exporter to the USaccessdata.fda.gov
Marker, SkinFZZ1Exporter to the USaccessdata.fda.gov
Mask, SurgicalFXX2Exporter to the USaccessdata.fda.gov
Mattress, Flotation Therapy, Non-PoweredIKY1Exporter to the USaccessdata.fda.gov
Needle, Hypodermic, Single LumenFMI2Exporter to the USaccessdata.fda.gov
Non-Surgical GownOEA1Exporter to the USaccessdata.fda.gov
Pill Crusher/CutterOHY1Exporter to the USaccessdata.fda.gov
Polymer Patient Examination GloveLZA1Exporter to the USaccessdata.fda.gov
Set, Administration, IntravascularFPA2Exporter to the USaccessdata.fda.gov
Stethoscope, ManualLDE1Exporter to the USaccessdata.fda.gov
Surgeon'S GlovesKGO1Exporter to the USaccessdata.fda.gov
Syringe, Irrigating (Non Dental)KYZ1Exporter to the USaccessdata.fda.gov
Syringe, PistonFMF2Exporter to the USaccessdata.fda.gov
System, Thermal RegulatingDWJ2Exporter to the USaccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Exporter to the USaccessdata.fda.gov
Tubes, Vials, Systems, Serum Separators, Blood CollectionJKA2Exporter to the USaccessdata.fda.gov
Tubing, NoninvasiveGAZ2Exporter to the USaccessdata.fda.gov
Tubing, Pressure And AccessoriesBYX1Exporter to the USaccessdata.fda.gov
Wrap, SterilizationFRG2Exporter to the USaccessdata.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
March 24, 2023K223236Medline Surgical Face Mask and Medline Procedural Face MaskFXXSubstantially EquivalentMedline Industries, LPaccessdata.fda.gov
March 24, 2023K220212BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button Blood Collection Set with Pre-Attached HolderJKASubstantially EquivalentBecton, Dickinson and Companyaccessdata.fda.gov
April 29, 2021K2106053M Bair Hugger Universal Warming Gown made with Thinsulate InsulationDWJSubstantially Equivalent3M Companyaccessdata.fda.gov
May 23, 2017K161833LATEX EXAMINATION GLOVE POWDER FREELYYSubstantially EquivalentCareglove Global Sdn. Bhd.accessdata.fda.gov
November 27, 2015K150238SensiCare Sterile Powder-Free Polymer Coated Polyisoprene Surgical glove, With Aloe Vera (Tested of Use with Chemotherapy Drugs) -Natural ColorKGOSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
April 10, 2012K112110STERILE LUBRICATING JELLYKMJSubstantially EquivalentJianerkang Medical Dressing Companyaccessdata.fda.gov
February 7, 2012K112591SAFE SECURE STERILIZATION POUNCH WITH STEAM AND ETHYLENE OXIDE PROCESS INDICATORSFRGSubstantially EquivalentSafe Secure Packaging Co., Ltd.accessdata.fda.gov
April 15, 2011K110921NITRILE POWDER-FREE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGSLZASubstantially EquivalentCardinal Health, Inc.accessdata.fda.gov
January 7, 2010K093349MEDLINE CURAD WOUND DRESSINGSFROSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
July 18, 2007K071423MEDLINE LATEX FOLEY CATHETEREZLSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
July 13, 2007K071354MEPILEX AG DRESSINGFROSubstantially EquivalentMonlycke Health Careaccessdata.fda.gov
July 10, 2007K070333ACRYDERM SILVER ANTIMICROBIAL OTC WOUND GELFROSubstantially EquivalentAcrymed, Inc.accessdata.fda.gov
May 8, 2003K030573BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET, MODELS 367338, 367344, 367336, 367342, 367335, 367341JKASubstantially EquivalentBd Vacutainer Systems Preanalyical Solutionsaccessdata.fda.gov
July 19, 2002K021475BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SETFMISubstantially EquivalentBdaccessdata.fda.gov
July 14, 2000K001924COATED STERILE LATEX POWDEER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM OR LESS0KGOSubstantially EquivalentAllegiance Healthcare Corp.accessdata.fda.gov
October 28, 1998K982541VACUTAINER BRAND ECLIPSE BLOOD COLLECTION NEEDLE, MODELS# 368607 & 368608FMISubstantially EquivalentBecton Dickinson Vacutainer Systemsaccessdata.fda.gov
March 1, 1995K945715MONOJECT(R) PISTON SYRINGES; 3,6,12,20,35 AND 60CC SIZESFMFSubstantially EquivalentSherwood Medical Co.accessdata.fda.gov

Compare with other makers

Updated March 24, 2023. 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.