FDA Registration Active 🇺🇸 United States

MERIT MEDICAL SYSTEMS, INC.

Reg #: 1721504 · FEI: 1721504 · Expires 2026
Products
122
Proprietary Names
391
Establishment Types
6
Classifications
122

Registration Details

Registration Name
MERIT MEDICAL SYSTEMS, INC.
Registration Number
1721504
FEI Number
1721504
Status
Active
Expiry Year
2026
Initial Importer
No
Address
1600 WEST MERIT PKWY.
City
South Jordan
State
UT
ZIP
84095
Country
US

Regulatory Submissions

510(k) Number
K101843
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

Products

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

Proprietary Names

Duramax Squirt Fluid Delivery System SPINR High-Performance Guidewire Catheter EndoMAXX 5.5 F Worley Advanced LVI Lateral Vein Introducer Micro Ace Advanced Micro Access System SAVI Prep Device SAVI Spacer VertecoR Bone Drill, 3 Osseoflex Straight Hand Drill Preston™ Transpedicular Drill Preston™ Hard Bone Introducer Preston™ Long Drill SafeSafeSheath, ClassicSheath, Input SSV , Split Sheath Introducer Kit With Valve; et al. SafeSheath CSG Introducer Sheath Kit , Worley Advanced CSG , Worley Advanced LVI Lateral Vein Introducers, et al. MiniStop Filter Closed Waste Basin InQwire Guidewire-Prelude Introducer Merit Disposal Depot ER2 Saturate Mixing System Prelude Plastic Jacketed Guide Wire Pericardiocentesis Catheter Kit Wrapsody Cell-Impermeable Endoprosthesis OneMark Detector Console OneMark DIS Probe 01 OneMark DIS Console & Probe Activities: Manufacturer OneMark Detection Imaging System OneMark Breast Localization Marker Fountain ValveTip Infusion Catheter ReSolve Dilators Non-vascular tissue dilators ARC Catheter Impress and Impress Legato Hydrophilic Angiographic Catheter Resilience Fully Covered Esophageal Stent System CentrosFLO Long-Term Hemodialysis Catheter Centros Long-Term Hemodialysis Catheter ASAP CATHETER Temno Evolution Maestro Microcatheter ASAPLP Embolectomy Catheter Merit InQwire® Amplatz Super Stiff Guide Wire Merit Safety Needle Merit CentrosFLO Long-Term Hemodialysis Catheter Merit Centros Long-Term Hemodialysis Catehter Flex-Neck Infant Catheter Liberator Beacon Tip Locking Stylet Byrd Dilator Sheath Set 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 WOUNDSEAL STATSEAL PreludeEASE Hydrophilic Sheath Introducer, 4F-6F Merit PAK InQwire Amplatz Super Stiff Guide Wire HeRO Graft Osseoflex SN Osseoflex SN+ Needle Osseoflex SN Needle Osseoflex Access Kit Rad Rest Safeguard Radial Compression Device Surfacer Inside-Out Access Catheter System Merit HeRO Graft Revolution Catheter Securement Dev. DriPAD Super Absorbent Pad Meritrans Disposable Transducer ExxTended Catheter 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) Osseoflex CD-H Hydraulic Cement Delivery System Softouch Diag. Intra Cath. w/Vessel Vessel Sizing Catheter (VSC) Worley Impress Angiographic Catheter 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 MultiPlex II Controller Activation Element, ERx bone cement Bearing nsPVA Embolization Particles Corvocet Coaxial Introducer Rad Trac Rad Board Xtra Rad Board Rad Board 2 Reusable Arm Board Prelude Sheath Introducer Insufflation Set K14 Dialysis Kit VacLok AT Syringe Alimaxx E VACLOK Syringe K02 Syringe Kit (multiple K01) K13 Label Kit AEROmini Tracheobronchial Stent System Merit Syringe BioSentry Tract Sealant System SteadySheath & Shortie InQwire PinVise Torque Device SCOUT MD Console SCOUT MD Delivery System SCOUT MD Guides SCOUT MD Single-Use Handpieces SCOUT Console and Accessory Cart Bulldog Lead Extender Contamination Sleeve, Cutter, Worley Slitter, Transavalvular Insertion Tool (TVI) One-Tie Compression Coil Lead Clippers Aero DV Tracheobronchial Stent System Cool Point Irrigation Pump Evolution RL & Evolution Shortie RL TruCut 14Ga Quick Silver H20 Guidewire ReSolve ConvertX Biliary Stent System PreludeEASE Hydrophilic Sheath Introducer, 7F SafeGuard Focus Compression Device (Adhesive Free) SafeGuard Focus Cool Device (Adhesive Free) Elation Pulmonary Balloon Go2Wire Guide Wire C2 Cryoballoon Endogrip Safeguard Pressure Assisted Dressing (24cm) Merit Pursue Microcatheter K01 Syringe Kit (1mL Polypropylene) 1 mL syringe(Polypropylene) ViaVerte RF Generator ViaVerte Steerable RF Ablation Kit BioFlo Duramax Cerenovus Aspiration Tubing set Prelude Wave Hydrophilic Sheath Introducer InQwire Super Stiff Guide Wire True Form Reshapable Guide Wire Preston™ Transpedicular Introducer Preston™ Hard Bone Access Needle with Drill Preston Bone Filler Aerosizer Temno Elite Biopsy Systems Bearing nsPVA Express C2 Cryoballoon Ablation System Guidewire with Palladium Tip Slip-Not Perchik Button Assembly Peritoneal Dialysis Catheter Connector Adjustable Biopsy Port Seal BPS-A Impress with Legato Hydrophilic Coating SAVI Applicator Kit Low Profile Companion Sheath Excite Contrast Injection Line Merit Pressure Monitoring Tubing Merit High Pressure Tubing Siege Vascular Plug K18 Sheath Introducer Kit (Ease) K15 Sheath Introducer Kit K21 Sheath Introducer Kit (IDeal) Arcadia Balloon Catheter KYPHON KyphoFlex Balloon Catheter Kit KYPHON KyphoFlex Balloon Catheter Arcadia Balloon Catheter Kit Valve Adapter Prelude SNAP 165 Valved Splittable Sheath Introducer Dash 9F Hydrophilic Sheath Introducer Merit 1mL Syringe (COP) Ventrax Delivery System HeartSpan Fixed Curve Braided Transseptal Sheath, Braided Guiding Introducer, EZ Cross Introducer Kit; et al. CardiaGuide Fixed Curve Braided Transseptal Sheath Prelude Prestige Splittable Sheath Introducer ASAP Aspiration Catheter ASAPLP Aspiration Catheter One Snare Endovascular Snare System ONE1501 Impress UAC Catheter K08 Fluid Management Kit K04 - Tubing Kit Aspira Pleural Drainage System K10 Waste Management Kit K10T - Waste Management Kit basixCompak Analog Inflation Syringe basixTOUCH BIG60 basixTOUCH40 Inflation Syringe BIG60 ALPHA Inflation Devie basixSKY Inflation Device Corvocet Biopsy System ReSolve Biliary Locking Drainage Catheter Prelude Short Sheath Introducer Micro Ace Gold Advanced Micro Access System Hydrophilic Prelude SNAP Splittable Sheath Introducer Sidecar External Working Channel (FG-1011) Elation Fixed Wire Balloon Elation5 Wireguided Balloon Elation5 Fixed Wire Balloon Prelude SNAP Splittable Sheath Introducer StabiliT Introducer and Delivery Instruments Maxxwire Osseoflex SB Straight Balloon (8ga) Cuff Implantor SafeGuard Focus Compression Device SafeGuard Focus Cool Device Osseoflex SB Steerable Balloon (10Ga) Monarch Syringe Fluid Dispense System 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 Splashwire Hydrophilic Guide Wire Futura Safety Scalpel FlowGuard Merit Convenience Kits SCOUT MD Single-use Handpieces HeartSpan Steerable Introducer Sheath Intellisystem Inflation Device Fluid Dispensing Syringe ASAP Catheter Fountain Infusion Catheter w/ Occluding Guide Wire Fountain Infusion System 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 Safety Paracentesis Tray (SPPT) Drainage Tubing Smart Tip Control Syringe Monarch Compak Inflation Syringe Blue Diamond Inflation Syringe PreludeSYNC EZ Radial Compression Device ClariVein OC Faller Trocar K16 Microcatheter Kit K11 Pressure Monitoring Kit K17 Interventional Kit K09 Manifold Kit K17T - Interventional Kit K09T - Manifold Kit ProGuide Long Term Hemodialysis Catheter EvenMore Chronic Hemodialysis Catheter ReSolve ConvertX Nephroureteral Stent System Repositional Chest Tube RTT14038MB Osseoflex SB Steerable Balloon (8ga) PAL (Pen and Labels) Family Ostial Pro Stent Positioning System SwiftNINJA Microcatheter Merit Administration Set CT Transfer Set Temno Original Temno ACT DiamondTOUCH Inflation Device and Fluid Dispensing Syringe RXP (Rapid Exchange Flushing Syringe) Performa Diagnostic Intravascular Catheter S-MAK XL EN Snare Endovascular Snare System Coronary Control Syringe K06 Syringe Kit (single CSS) K07 Syringe Kit (multiple K06) StayFix Fixation Device Embedding Tool Medallion Syringe K01 Kit (MSS) Spectranetics K02 Syringe Kit (multiple K01)) OuTake Catheter Extractor Aero Tracheo Stent and Delivery System Introducer Needle WithTrocar Stylet MAK-NV Non-Vascular InQwire Diagnostic (Support) Non-Vascular Guide Wire Concierge Guiding Catheter Pressure Infusor Bags (PIB) Merit Hydrophilic Guide Wire DualCap Solo DualCap DualCap Duo DualCap IV Pole Strips Dark Blue Cap for Male Luers Stylette (rod obturator) Roadster Guide Sheath OneSnare Endovascular Snare System Fountain Catheter/Occluding Guide Wire Merit Triboglide Syringe Guidewire Introducer MAP Torque Device & Introducer 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 ClariVein IC Infusion Catheter Prelude IDeal Hydrophilic Sheath Introducer Achieve Pink Achieve Miser Contrast Management System Thoracentesis Tray (TAPS) Aspira Peritoneal Drainage System TRAM-P TRAM Flex-Neck Catheter Merit 20 mL Syringe (COP) K01 Syringe Kit (1mL & 20mL COP) Merit MAK (Mini Access Kit) Merit S-MAK (Stiffened Mini Access Kit) Splashwire Hydrophilic guide wire Sterilized Convenience Kits HeartSpan Steerable Sheath Introducer SpineSTAR Ablation Instruments STAR Tumor Ablation Kit with PowerCURVE STAR Tumor Ablation Kit and Accessories MetaSTAR RF Generator SCOUT Bx Delivery System InQwire Guidewires Elation Pulmonary Balloon 4mm Elation Wireguided Balloon Solo Pace Fusion System (SOLOFUSE1) Merit Drainage Depot Novatome Endomyocardial Biopsy Forceps Straightline Osteotome, VerteCOR Midline Osteotome PowerCURVE Navigating Osteotome Finale Radial Compression System RADstat Radial Artery Compression Device BowTie Guide Wire Insertion Device Flex-Neck Extender/Repair Kit Hydrophilic Guidewire SureCross Support Catheter ReSolve Non-Locking Drainage Catheter ReSolve Locking Drainage Catheter One-Step Centesis Catheter FastBreak Connector Cen-Step Centesis Catheter SwiftNINJA Steerable Microcatheter Osseoflex SB Straight Balloon (10ga) Mighty Wire PreludeSYNC DISTAL Radial Compression Device PreludeSYNC EVO Radial Compression Device Solo Pace Control EsophyX Z+ Device Acutiy Universal Cutter HeartLight Deflectable Sheath One-Vac Evacuated Drainage Bottle Advance Angiographic Needle Majestik Angiographic Needle Transseptal Needle,HeartSpan Transseptal Needle&Stylet Set,TSX Transseptal Needle,Transseptal Needle&Stylet Set;et al. Fountain 4F Catheter & Occluding GW TruCut 18Ga DuraFlow 2 Hemodialysis Catheter Prelude Sheath Half Size (ACT) SCOUT Single-Use Handpiece, SCOUT Surgical Guides SCOUT Reflector and Delivery Systems SCOUT Surgical Console and SCOUT Check Console Safeguard Pressure Assisted Device (12cm) K20 Endoscopic Kit BRC-BAL-INT-FL/A K20T - Endoscopic Kit Pinvise Torque Device SeaDragon Torque Device Universal Coaxial Needles

Establishment Types

Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Device in the United States for Export Only