BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Merit Medical Canada Ltd.

    Reg #: 3012536737 · FEI: 3012536737 · Expires 2026
    View on FDA
    Products
    129
    Proprietary Names
    408
    Establishment Types
    1
    Classifications
    129

    Registration Details

    Registration Name
    Merit Medical Canada Ltd.
    Registration Number
    3012536737
    FEI Number
    3012536737
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1 Valleywood Drive, units 4&5
    City
    Markham Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K935170
    PMA Number
    P240023

    Owner / Operator

    Firm Name
    Merit Medical Systems, Inc.
    Operator Number
    1721504
    Address
    1600 West Merit Parkway, --
    City
    South Jordan
    State
    UT
    Postal Code
    84095
    Country
    US

    US Agent

    Business Name
    MERIT MEDICAL SYSTEMS, INC.
    Contact Name
    John Knorpp
    Address
    1600 West Merit Parkway, --
    City
    South Jordan
    State
    UT
    ZIP
    84095
    Country
    US
    Email
    [email protected]
    Phone
    801 2084389

    Products

    Device Name Product Code
    Endoscopic Guidewire, Gastroenterology-Urology OCY
    Wire, Guide, Catheter DQX
    Catheter, Intravascular, Diagnostic DQO
    Kit, Surgical Instrument, Disposable KDD
    Injector And Syringe, Angiographic DXT
    Transducer, Blood-Pressure, Extravascular DRS
    Prosthesis, Tracheal, Expandable JCT
    Label Or Tag, Sterile LYV
    Introducer, Catheter DYB
    Wire, Guide, Catheter, Exempt PTL
    Catheter, Peritoneal, Long-Term Indwelling FJS
    Injector, Vertebroplasty (Does Not Contain Cement) OAR
    Device, Biopsy, Endomyocardial DWZ
    Clamp, Vascular DXC
    Hemostatic Wound Dressing Without Thrombin Or Other Biologics QSY
    Syringe, Piston FMF
    Marker, Radiographic, Implantable NEU
    Reverse Central Venous Recanalization System QJH
    Stents, Drains And Dilators For The Biliary Ducts FGE
    Catheter, Continuous Flush KRA
    Aspiration Thrombectomy Catheter QEZ
    Arthroscope HRX
    Cement, Bone, Vertebroplasty NDN
    Prosthesis, Esophageal ESW
    Dispenser, Cement KIH
    Needle, Catheter GCB
    Biopsy Needle FCG
    Fluid Drainage Tray PXU
    Dilator, Vessel, For Percutaneous Catheterization DRE
    Catheter, Irrigation GBX
    Catheter, Hemodialysis, Implanted MSD
    Device, Percutaneous Retrieval MMX
    Thoracentesis Tray PXI
    Instrument, Biopsy KNW
    Support, Patient Position CCX
    Tubing, Fluid Delivery FPK
    Cannula, Surgical, General & Plastic Surgery GEA
    Actuator, Syringe, Injector Type DQF
    Probe, Thermodilution KRB
    Bottle, Collection, Vacuum KDQ
    Probe, Radiofrequency Lesion GXI
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Tourniquet, Nonpneumatic GAX
    Catheter, Steerable DRA
    Syringe, Irrigating (Non Dental) KYZ
    Unit, Filter, Membrane JRL
    Electrode, Pacemaker, Temporary LDF
    Cardiovascular Catheter Sheath Introducer Kit OEX
    Apparatus, Suction, Patient Care DWM
    Device, Vascular, For Promoting Embolization KRD
    Instruments, Surgical, Cardiovascular DWS
    Guide, Surgical, Instrument FZX
    Infusor, Pressure, For I.V. Bags KZD
    Needle, Biopsy, Cardiovascular DWO
    Bronchoscope Accessory KTI
    Catheter, Percutaneous DQY
    Orthopedic Manual Surgical Instrument LXH
    Stopcock, I.V. Set FMG
    System, Applicator, Radionuclide, Remote-Controlled JAQ
    Cystoscope And Accessories, Flexible/Rigid FAJ
    Syringe, Balloon Inflation, Exempt PTM
    Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling PNG
    Device, Intravascular Catheter Securement KMK
    Bag, Bile Collecting EXF
    Intravenous Extension Tubing Set OJA
    Unit, Electrosurgical, Endoscopic (With Or Without Accessories) KNS
    Stylet, Surgical, General & Plastic Surgery GAH
    Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia NOY
    Peripheral Catheter Insertion Kit OWL
    Prosthesis, Vascular Graft, Of 6mm And Greater Diameter DSY
    Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days LJS
    Mixer, Cement, For Clinical Use JDZ
    Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd) ODE
    Mechanical Thrombolysis Catheter QEY
    Syringe, Balloon Inflation MAV
    Accessories, Catheter KGZ
    Catheter, Peritoneal Dialysis, Single Use FKO
    Angiography/Angioplasty Kit OEQ
    Dilator, Catheter GCC
    Endoscopic Access Overtube, Gastroenterology-Urology FED
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
    Cap, Device Disinfectant QBP
    System, Peritoneal, Automatic Delivery FKX
    Set, Administration, Intravascular FPA
    Minor Surgical Procedures Tray PYB
    Device, Neurovascular Embolization HCG
    Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL
    Bone Cement LOD
    Bulb, Inflation, For Endoscope FCY
    Non-Bronchoscopic Bronchoalveolar Lavage Catheter OYI
    Catheter, Peritoneal GBW
    Stent, Ureteral FAD
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Cart, Emergency, Cardiopulmonary (Excluding Equipment) BZN
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
    Bandage, Elastic FQM
    Computer, Blood-Pressure DSK
    Tourniquet, Pneumatic KCY
    Instrument, Surgical, Disposable KDC
    Universal Drainage Tray PPD
    Trocar DRC
    Cardiovascular Procedure Kit OEZ
    Bedding, Disposable, Medical KME
    Transducer, Pressure, Catheter Tip DXO
    System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment PFV
    Catheter And Tip, Suction JOL
    Single Use Instrument Tray OJV
    Dilator, Esophageal KNQ
    Computer, Diagnostic, Pre-Programmed, Single-Function DXG
    Retention Device, Suture KGS
    Paracentesis Tray PYC
    Dressing, Compression MHW
    Tunneled Catheter Remover ODY
    Tamp HXG
    Pulse-Generator, Pacemaker, External DTE
    Tape And Bandage, Adhesive KGX
    Guide, Needle, Surgical GDF
    Dialysis Administration Kit PEV
    Endoscopic Irrigation/Suction System OCX
    Bit, Drill HTW
    Needle, Aspiration And Injection, Disposable GAA
    Absorbable Lung Biopsy Plug OMT
    Table And Attachments, Operating-Room BWN
    Endoscope Introducer Kit NWU
    Unit, Cryosurgical, Accessories GEH
    Instrument, Manual, Surgical, General Use MDM
    Vacuum Syringe PUR
    Device, Measuring, For Panendoscope FDY
    Blade, Scalpel GES

    Proprietary Names

    InQwire Diagnostic (Support) Non-Vascular Guide Wire InQwire Integral Injectate Temperature Probe Catheter Connection Cable Disposable In Line Sensor Housing Sterilized Convenience Kits Coronary Control Syringe K06 Syringe Kit (single CSS) K07 Syringe Kit (multiple K06) Meritrans ECO Reusable Pressure Transducer and Meritrans ECO Disposable Domes Aero DV Tracheobronchial Stent System PAL (Pen and Labels) Family HeartSpan Steerable Introducer Sheath Pinvise Torque Device SeaDragon Torque Device Go2Wire Guide Wire Faller Trocar X-Change Cement Dispensing Syringe Hydraulic Assembly Osseon Bone Filler Device (BFD) StabiliT Cement Delivery Syringe Hydraulic-Master Syringe Assembly Purge Assist Master Syringe Assembly DiamondTOUCH Syringe Flex-Neck Infant Catheter Merit Hydrophilic Guide Wire Novatome Endomyocardial Biopsy Forceps PreludeSYNC EZ Radial Compression Device Ostial Pro Stent Positioning System Exacta Percutaneous Sheath Introducer STATSEAL WOUNDSEAL PreludeEASE Hydrophilic Sheath Introducer, 4F-6F Merit PAK FlowGuard Merit Triboglide Syringe SCOUT MD Console SCOUT MD Delivery System SCOUT MD Guides SCOUT MD Single-Use Handpieces Surfacer Inside-Out Access Catheter System Elation Wireguided Balloon H20 Guidewire ClariVein IC Infusion Catheter ASAP Catheter Osseoflex SB Straight Balloon (10ga) Alimaxx E Meritrans Disposable Transducer Embedding Tool MultiPlex II Controller Activation Element, ERx bone cement Introducer Needle WithTrocar Stylet MAK-NV Non-Vascular Corvocet Coaxial Introducer ARC Catheter Impress UAC Catheter Pericardiocentesis Catheter Kit S-MAK XL ReSolve Non-Locking Drainage Catheter ReSolve Locking Drainage Catheter One-Step Centesis Catheter FastBreak Connector Cen-Step Centesis Catheter CentrosFLO Long-Term Hemodialysis Catheter Centros Long-Term Hemodialysis Catheter Impress with Legato Hydrophilic Coating One Snare Endovascular Snare System ONE1501 Thoracentesis Tray (TAPS) Corvocet Biopsy System Rad Rest Excite Contrast Injection Line Merit Pressure Monitoring Tubing Merit High Pressure Tubing Preston™ Transpedicular Introducer Preston™ Hard Bone Access Needle with Drill Preston Bone Filler Maestro Microcatheter Spectraject Control Syringe Critikit Plus In-Line Room/ Ice Injectate Micro Ace Advanced Micro Access System One-Vac Evacuated Drainage Bottle ViaVerte RF Generator ViaVerte Steerable RF Ablation Kit Finale Radial Compression System RADstat Radial Artery Compression Device HeartLight Deflectable Sheath RXP (Rapid Exchange Flushing Syringe) MiniStop Filter Closed Waste Basin Safeguard Radial Compression Device Solo Pace Fusion System (SOLOFUSE1) K18 Sheath Introducer Kit (Ease) K15 Sheath Introducer Kit K21 Sheath Introducer Kit (IDeal) Fountain ValveTip Infusion Catheter Flex-Neck Extender/Repair Kit ReSolve ConvertX Biliary Stent System SCOUT Bx Delivery System Dash 9F Hydrophilic Sheath Introducer Medallion Syringe K01 Kit (MSS) Spectranetics K02 Syringe Kit (multiple K01)) Prelude SNAP Splittable Sheath Introducer Temno Elite Biopsy Systems Mighty Wire Aspira Peritoneal Drainage System Micro Plug Set Bulldog Lead Extender Contamination Sleeve, Cutter, Worley Slitter, Transavalvular Insertion Tool (TVI) One-Tie Compression Coil Lead Clippers Worley Impress Angiographic Catheter Merit CentrosFLO Long-Term Hemodialysis Catheter Merit Centros Long-Term Hemodialysis Catehter BowTie Guide Wire Insertion Device Pressure Infusor Bags (PIB) True Form Reshapable Guide Wire Intellisystem Inflation Device Fluid Dispensing Syringe Elation Pulmonary Balloon 4mm SafeSafeSheath, ClassicSheath, Input SSV , Split Sheath Introducer Kit With Valve; et al. Prelude Prestige Splittable Sheath Introducer SwiftNINJA Steerable Microcatheter Merit 1mL Syringe (COP) Prelude Wave Hydrophilic Sheath Introducer SureCross Support Catheter Acutiy Universal Cutter Straightline Osteotome, VerteCOR Midline Osteotome PowerCURVE Navigating Osteotome Connecta PE Lines SAVI Prep Device SAVI Spacer Adjustable Biopsy Port Seal BPS-A Prelude Short Sheath Introducer basixCompak Analog Inflation Syringe basixTOUCH BIG60 basixTOUCH40 Inflation Syringe BIG60 ALPHA Inflation Devie basixSKY Inflation Device EvenMore Chronic Hemodialysis Catheter Revolution Catheter Securement Dev. Merit Drainage Depot Impress and Impress Legato Hydrophilic Angiographic Catheter K08 Fluid Management Kit K04 - Tubing Kit Quick Silver Osseoflex SN Osseoflex SN+ Needle Osseoflex SN Needle Osseoflex Access Kit Hydrophilic Prelude SNAP Splittable Sheath Introducer Embosphere Microspheres Emboshpere PRO K16 Microcatheter Kit Merit HeRO Graft HeRO Graft HeartSpan Steerable Sheath Introducer Hydrophilic Guidewire Elation Pulmonary Balloon ER2 Saturate Mixing System ASAPLP Embolectomy Catheter EsophyX Z+ Device Fountain Infusion Catheter w/ Occluding Guide Wire Fountain Infusion System Monarch Syringe Fluid Dispense System Prelude Sheath Introducer TruCut 18Ga Valve Adapter Prelude SNAP 165 Valved Splittable Sheath Introducer Prelude Plastic Jacketed Guide Wire Peritoneal Dialysis Catheter Connector Aspira Pleural Drainage System BioFlo Duramax K12 Procedure Kit K19 Combination Packs K05 Inflation Kit K23C Vein Accessory Kit K22C Vein Tray K12T - Procedure Kit K05T - Inflation Kit 10Fore Hemostasis Valve Kit K02-00873A, K02-01105A, K02-01481A Squirt Fluid Delivery System ReSolve Dilators Non-vascular tissue dilators Sidecar External Working Channel (FG-1011) SafT Needle Direct Blood Transfer K01 Syringe Kit (1mL Polypropylene) K02 Syringe Kit (multiple K01) 1 mL syringe(Polypropylene) DualCap Solo DualCap DualCap Duo DualCap IV Pole Strips Dark Blue Cap for Male Luers Stylette (rod obturator) Low Profile Companion Sheath OneSnare Endovascular Snare System Smart Tip Control Syringe SCOUT Single-Use Handpiece, SCOUT Surgical Guides SCOUT Reflector and Delivery Systems SCOUT Surgical Console and SCOUT Check Console Ventrax Delivery System Merit Administration Set CT Transfer Set Merit Disposal Depot PreludeSYNC DISTAL Radial Compression Device PreludeSYNC EVO Radial Compression Device K13 Label Kit EmboGold Microspheres Rotating Adaptor Stopcock One Port Manifold Hemostasis Valve Adapter SafeSheath Sealing Adapter Merit Manifold DoublePlay Hemostasis Valve MYSHELL Hemostatic Valve FLO30 Honor hemostasis valve Passage Hemostasis Valve FLO40XR Merit Marquis Flow Switch Merit Marquis Stopcock Prelude Choice Hemostasis Valve Adapter PhD Hemostasis Valves & PhD Hemostasis Valves with Sidearm Tubing Access-9 H20 Torque Device AccessPLUS MBA Check Valve NeoVasc FLO50 10Fore Hemostasis Valve Merit Safety Needle EN Snare Endovascular Snare System Osseoflex SB Steerable Balloon (10Ga) Insufflation Set Brochoalveloar Lavage (BAL) Custom Convenience Kit Aero Tracheo Stent and Delivery System Percutaneous Peritoneal Dialysis Catheter Implantation Systems (VP-511, VP-511M) Laparoscopic Peritoneal Dialysis Catheter Implantation Systems (VP-411) Peritoneoscopic or Laparoscopic Peritoneal Dialysis Catheter Implantation Systems (VP-210, VP-211) PreludeEASE Hydrophilic Sheath Introducer, 7F ReSolve ConvertX Nephroureteral Stent System Osseoflex SB Straight Balloon (8ga) Concierge Guiding Catheter DTX Disposable Temperature Probe DTX/DTX Plus Kit and Accessories DTX Plus Disposable Pressure Transducer ProGuide Long Term Hemodialysis Catheter SafeSheath CSG Introducer Sheath Kit , Worley Advanced CSG , Worley Advanced LVI Lateral Vein Introducers, et al. Safeguard Pressure Assisted Dressing (24cm) SCOUT Console and Accessory Cart Careflow Central Venous Catheter SafeGuard Focus Compression Device (Adhesive Free) SafeGuard Focus Cool Device (Adhesive Free) Temno Original Temno ACT EndoMAXX Guidewire Introducer MAP Torque Device & Introducer Safedraw Blood Sampling System Safeguard Pressure Assisted Device (12cm) Merit 20 mL Syringe (COP) K01 Syringe Kit (1mL & 20mL COP) Duramax AEROmini Tracheobronchial Stent System Vessel Dilator Cuff Implantor K10 Waste Management Kit K10T - Waste Management Kit Tubing, Fluid Delivery Advance Angiographic Needle Majestik Angiographic Needle Transseptal Needle,HeartSpan Transseptal Needle&Stylet Set,TSX Transseptal Needle,Transseptal Needle&Stylet Set;et al. Monarch Compak Inflation Syringe Blue Diamond Inflation Syringe Prelude Sheath Half Size (ACT) Micro Ace Gold Advanced Micro Access System ExxTended Catheter K11 Pressure Monitoring Kit K17 Interventional Kit K09 Manifold Kit K17T - Interventional Kit K09T - Manifold Kit Pressure Tubing DiamondTOUCH Inflation Device and Fluid Dispensing Syringe SpineSTAR Ablation Instruments STAR Tumor Ablation Kit with PowerCURVE STAR Tumor Ablation Kit and Accessories MetaSTAR RF Generator Merit Pursue Microcatheter PinVise Torque Device DriPAD Super Absorbent Pad Physiological Reusable Pressure Transducer Wrapsody Cell-Impermeable Endoprosthesis Merit InQwire® Amplatz Super Stiff Guide Wire Repositional Chest Tube RTT14038MB 5.5 F Worley Advanced LVI Lateral Vein Introducer Flex-Neck Catheter Merit Convenience Kits Elation Fixed Wire Balloon Elation5 Wireguided Balloon Elation5 Fixed Wire Balloon Bath Probe Catheter Connection Cables and Cardia Computer Injectate Sensor Cable Slip-Not Perchik Button Assembly Safety Paracentesis Tray (SPPT) Drainage Tubing SafeGuard Focus Compression Device SafeGuard Focus Cool Device Siege Vascular Plug Roadster Guide Sheath SCOUT MD Single-use Handpieces TruCut 14Ga OuTake Catheter Extractor Achieve Pink Achieve SPINR High-Performance Guidewire Catheter QuadraSphere Q2 Microspheres QuadraSphere Microspheres Guidewire with Palladium Tip Arcadia Balloon Catheter KYPHON KyphoFlex Balloon Catheter Kit KYPHON KyphoFlex Balloon Catheter Arcadia Balloon Catheter Kit SAVI Applicator Kit Solo Pace Control TRAM-P TRAM Critiflo Disposable Diaphragm Dome Fountain Catheter/Occluding Guide Wire StayFix Fixation Device StabiliT ER2 Bone Cement and Saturate Mixing System StabiliT MX Fracture Kits StabiliT VP Vertebrosplasty Kit StabiliT VP Fracture Kits StabiliT MX Fracture Kits with PowerCURVE StabiliT Bone Cement and Saturate Mixing System Temno Evolution InQwire Amplatz Super Stiff Guide Wire ROSE ASAP Aspiration Catheter ASAPLP Aspiration Catheter Softouch Diag. Intra Cath. w/Vessel Vessel Sizing Catheter (VSC) Universal Coaxial Needles K14 Dialysis Kit Critiflo Dome Critiflo C2 Cryoballoon Endogrip VertecoR Bone Drill, 3 Osseoflex Straight Hand Drill Preston™ Transpedicular Drill Preston™ Hard Bone Introducer Preston™ Long Drill InQwire Guidewires S-MAK ShortStop Grandstand Temporary Sharps Holder ShortStop Advantage Temporary Sharps Holder MiniStop Plus Closed Waste Basin ShortStop Temporary Sharps Holder BackStop Plus Closed Waste Basin Kensington Guide Wire Bone Biopsy System Madison™ Perforating Bone Biopsy System with Drill Westbrook™ Bone Biopsy System Madison Mini™ Bone Biopsy System Bedford™ Guided Hard Bone Biopsy System Huntington Guided, Perforating Bone Biospy System with Drill Merit Syringe BioSentry Tract Sealant System Miser Contrast Management System Rad Trac Rad Board Xtra Rad Board Rad Board 2 Reusable Arm Board Secalon T Catheter InQwire Guidewire-Prelude Introducer Osseoflex CD-H Hydraulic Cement Delivery System ReSolve Biliary Locking Drainage Catheter Osseoflex SB Steerable Balloon (8ga) VACLOK Syringe Prelude IDeal Hydrophilic Sheath Introducer HeartSpan Fixed Curve Braided Transseptal Sheath, Braided Guiding Introducer, EZ Cross Introducer Kit; et al. CardiaGuide Fixed Curve Braided Transseptal Sheath Torpedo Gelatin Foam Resilience Fully Covered Esophageal Stent System K20 Endoscopic Kit BRC-BAL-INT-FL/A K20T - Endoscopic Kit C2 Cryoballoon Ablation System DuraFlow 2 Hemodialysis Catheter Fountain 4F Catheter & Occluding GW StabiliT Introducer and Delivery Instruments Maxxwire VacLok AT Syringe SwiftNINJA Microcatheter Merit MAK (Mini Access Kit) Merit S-MAK (Stiffened Mini Access Kit) Performa Diagnostic Intravascular Catheter Aerosizer Futura Safety Scalpel

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device