FDA Registration
Active
🇦🇺 Australia
Merit Medical Australia Pty Ltd.
Reg #: 3033589330
·
FEI: 3033589330
·
Expires 2026
Products
129
Proprietary Names
405
Establishment Types
1
Classifications
129
Registration Details
- Registration Name
- Merit Medical Australia Pty Ltd.
- Registration Number
- 3033589330
- FEI Number
- 3033589330
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 53 Canterbury Road
- City
- Braiside Victoria
- Country
- AU
Regulatory Submissions
- 510(k) Number
- K170933
- 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 protected]
- Phone
- 801 2084389
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2017-06-27 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2025-02-12 |
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2018-03-15 |
| Cement, Bone, Vertebroplasty | NDN | Class 2 | Orthopedic | No | 2016-08-05 |
| Dispenser, Cement | KIH | Class 1 | Orthopedic | No | 2016-08-05 |
| Device, Measuring, For Panendoscope | FDY | Class 1 | Gastroenterology, Urology | No | 2009-06-11 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2019-08-08 |
| Intravenous Extension Tubing Set | OJA | Class 2 | General Hospital | No | 2018-07-17 |
| Wire, Guide, Catheter, Exempt | PTL | Class 2 | Cardiovascular | No | 2017-07-27 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2017-04-06 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2015-08-26 |
| Prosthesis, Tracheal, Expandable | JCT | Class 2 | General, Plastic Surgery | No | 2014-12-09 |
| Hemostatic Wound Dressing Without Thrombin Or Other Biologics | QSY | Class U | Unknown | No | 2025-06-02 |
| Cap, Device Disinfectant | QBP | Class 2 | General Hospital | No | 2017-03-01 |
| Dilator, Vessel, For Percutaneous Catheterization | DRE | Class 2 | Cardiovascular | No | 2007-12-07 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2016-08-05 |
| Unit, Filter, Membrane | JRL | Class 1 | Clinical Chemistry | No | 2013-12-06 |
| Dilator, Esophageal | KNQ | Class 2 | Gastroenterology, Urology | No | 2015-05-01 |
| Device, Vascular, For Promoting Embolization | KRD | Class 2 | Cardiovascular | No | 2022-01-18 |
| Catheter, Continuous Flush | KRA | Class 2 | Cardiovascular | No | 2017-09-05 |
| Accessories, Catheter | KGZ | Class 1 | General, Plastic Surgery | No | 2003-12-18 |
| Cart, Emergency, Cardiopulmonary (Excluding Equipment) | BZN | Class 1 | Anesthesiology | No | 2021-01-27 |
| Bone Cement | LOD | Class 2 | Orthopedic | No | 2017-07-27 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2001-07-14 |
| Transducer, Blood-Pressure, Extravascular | DRS | Class 2 | Cardiovascular | No | 2017-02-17 |
| Mechanical Thrombolysis Catheter | QEY | Class 2 | Cardiovascular | No | 2016-11-09 |
| Bag, Bile Collecting | EXF | Class 2 | Gastroenterology, Urology | No | 2017-07-24 |
| Catheter, Peritoneal Dialysis, Single Use | FKO | Class 2 | Gastroenterology, Urology | No | 2012-12-21 |
| Apparatus, Suction, Patient Care | DWM | Class 2 | Cardiovascular | No | 2018-03-15 |
| System, Peritoneal, Automatic Delivery | FKX | Class 2 | Gastroenterology, Urology | No | 2012-12-21 |
| Marker, Radiographic, Implantable | NEU | Class 2 | General, Plastic Surgery | No | 2022-08-25 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2018-02-07 |
| Biopsy Needle | FCG | Class 2 | Gastroenterology, Urology | No | 2018-03-15 |
| Device, Biopsy, Endomyocardial | DWZ | Class 2 | Cardiovascular | No | 2025-01-22 |
| Endoscope Introducer Kit | NWU | Class 2 | Gastroenterology, Urology | No | 2018-08-01 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2003-06-05 |
| Catheter, Hemodialysis, Implanted | MSD | Class 2 | Gastroenterology, Urology | No | 2023-06-08 |
| Bulb, Inflation, For Endoscope | FCY | Class 1 | Gastroenterology, Urology | No | 2012-12-21 |
| Catheter, Peritoneal, Long-Term Indwelling | FJS | Class 2 | Gastroenterology, Urology | No | 2012-12-21 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2017-07-27 |
| Trocar | DRC | Class 2 | Cardiovascular | No | 2007-12-07 |
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 2013-10-24 |
| Clamp, Vascular | DXC | Class 2 | Cardiovascular | No | 2018-04-18 |
| Stopcock, I.V. Set | FMG | Class 2 | General Hospital | No | 2017-02-17 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2009-06-11 |
| Device, Percutaneous Retrieval | MMX | Class 2 | Cardiovascular | No | 2015-07-03 |
| Angiography/Angioplasty Kit | OEQ | Class 2 | Cardiovascular | No | 2018-08-01 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2012-09-04 |
| Actuator, Syringe, Injector Type | DQF | Class 2 | Cardiovascular | No | 2017-02-17 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2007-12-07 |
| Universal Drainage Tray | PPD | Class 2 | Gastroenterology, Urology | No | 2018-08-01 |
| Probe, Thermodilution | KRB | Class 2 | Cardiovascular | No | 2017-02-17 |
| Aspiration Thrombectomy Catheter | QEZ | Class 2 | Cardiovascular | No | 2013-12-05 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2017-02-17 |
| Reverse Central Venous Recanalization System | QJH | Class 2 | Cardiovascular | No | 2025-12-19 |
| Single Use Instrument Tray | OJV | Class 1 | General, Plastic Surgery | No | 2015-05-18 |
| Injector And Syringe, Angiographic | DXT | Class 2 | Cardiovascular | No | 2006-08-11 |
| Needle, Biopsy, Cardiovascular | DWO | Class 1 | General, Plastic Surgery | No | 2018-07-19 |
| System, Applicator, Radionuclide, Remote-Controlled | JAQ | Class 2 | Radiology | No | 2018-11-28 |
| Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | DTL | Class 2 | Cardiovascular | No | 2011-10-21 |
| Unit, Cryosurgical, Accessories | GEH | Class 2 | General, Plastic Surgery | No | 2026-05-08 |
| Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | DSY | Class 2 | Cardiovascular | No | 2021-06-02 |
| Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | LJS | Class 2 | General Hospital | No | 2021-06-02 |
| Minor Surgical Procedures Tray | PYB | Class 1 | General, Plastic Surgery | No | 2018-08-01 |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | Class 2 | Gastroenterology, Urology | No | 2014-12-02 |
| Mixer, Cement, For Clinical Use | JDZ | Class 1 | Orthopedic | No | 2016-08-05 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2003-06-05 |
| Syringe, Balloon Inflation | MAV | Class 2 | Cardiovascular | No | 2016-08-09 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2017-02-17 |
| Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling | PNG | Class 2 | Gastroenterology, Urology | No | 2023-10-18 |
| Infusor, Pressure, For I.V. Bags | KZD | Class 1 | General Hospital | No | 2003-12-18 |
| Dialysis Administration Kit | PEV | Class 2 | Gastroenterology, Urology | No | 2018-08-01 |
| Paracentesis Tray | PYC | Class 1 | General, Plastic Surgery | No | 2023-03-10 |
| Device, Neurovascular Embolization | HCG | Class 2 | Neurology | No | 2017-01-26 |
| Tubing, Fluid Delivery | FPK | Class 2 | General Hospital | No | 2007-12-19 |
| Syringe, Balloon Inflation, Exempt | PTM | Class 2 | Cardiovascular | No | 2017-07-27 |
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2017-02-17 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2016-08-05 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2018-12-21 |
| Endoscopic Guidewire, Gastroenterology-Urology | OCY | Class 2 | Gastroenterology, Urology | No | 2024-03-08 |
| Tourniquet, Pneumatic | KCY | Class 1 | General, Plastic Surgery | No | 2016-03-30 |
| System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment | PFV | Class 3 | Unknown | No | 2024-12-20 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2016-08-05 |
| Thoracentesis Tray | PXI | Class 2 | General Hospital | No | 2023-05-19 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2018-03-27 |
| Prosthesis, Esophageal | ESW | Class 2 | General, Plastic Surgery | No | 2009-06-12 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2017-11-15 |
| Stylet, Surgical, General & Plastic Surgery | GAH | Class 1 | General, Plastic Surgery | No | 2017-07-27 |
| Dilator, Catheter | GCC | Class 1 | General, Plastic Surgery | No | 2014-07-02 |
| Peripheral Catheter Insertion Kit | OWL | Class 2 | General Hospital | No | 2018-08-01 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2003-12-18 |
| Computer, Diagnostic, Pre-Programmed, Single-Function | DXG | Class 2 | Cardiovascular | No | 2017-02-17 |
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | Class 2 | Gastroenterology, Urology | No | 2026-05-08 |
| Bronchoscope Accessory | KTI | Class 2 | Ear, Nose, Throat | No | 2016-09-06 |
| Absorbable Lung Biopsy Plug | OMT | Class 2 | General, Plastic Surgery | No | 2023-06-08 |
| Dressing, Compression | MHW | Class 1 | General Hospital | No | 2020-09-09 |
| Injector, Vertebroplasty (Does Not Contain Cement) | OAR | Class 1 | Orthopedic | No | 2013-11-11 |
| Tunneled Catheter Remover | ODY | Class 2 | General Hospital | No | 2009-02-20 |
| Bottle, Collection, Vacuum | KDQ | Class 2 | General Hospital | No | 2021-06-23 |
| Vacuum Syringe | PUR | Class 2 | General Hospital | No | 2017-07-28 |
| Endoscopic Irrigation/Suction System | OCX | Class 2 | Gastroenterology, Urology | No | 2026-05-08 |
| Device, Intravascular Catheter Securement | KMK | Class 1 | General Hospital | No | 2006-02-14 |
| Non-Bronchoscopic Bronchoalveolar Lavage Catheter | OYI | Class 1 | Anesthesiology | No | 2015-12-09 |
| Stent, Ureteral | FAD | Class 2 | Gastroenterology, Urology | No | 2019-07-12 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2008-04-11 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2020-09-09 |
| Electrode, Pacemaker, Temporary | LDF | Class 2 | Cardiovascular | No | 2026-04-14 |
| Catheter, Peritoneal | GBW | Class 1 | General, Plastic Surgery | No | 2014-03-21 |
| Cardiovascular Catheter Sheath Introducer Kit | OEX | Class 2 | Cardiovascular | No | 2018-08-01 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2013-01-17 |
| Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | KNS | Class 2 | Gastroenterology, Urology | No | 2010-12-13 |
| Catheter, Steerable | DRA | Class 2 | Cardiovascular | No | 2017-06-30 |
| Transducer, Pressure, Catheter Tip | DXO | Class 2 | Cardiovascular | No | 2017-02-17 |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | Class 2 | Gastroenterology, Urology | No | 2014-02-14 |
| Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd) | ODE | Class 2 | Gastroenterology, Urology | No | 2024-07-31 |
| Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia | NOY | Class 2 | Gastroenterology, Urology | No | 2017-09-08 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2019-11-05 |
| Cardiovascular Procedure Kit | OEZ | Class 2 | Cardiovascular | No | 2018-08-01 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2013-06-11 |
| Probe, Radiofrequency Lesion | GXI | Class 2 | Neurology | No | 2026-04-16 |
| Label Or Tag, Sterile | LYV | Class 1 | General, Plastic Surgery | No | 2008-10-09 |
| Pulse-Generator, Pacemaker, External | DTE | Class 2 | Cardiovascular | No | 2026-04-14 |
| Needle, Catheter | GCB | Class 1 | General, Plastic Surgery | No | 1992-07-14 |
| Fluid Drainage Tray | PXU | Class 1 | General, Plastic Surgery | No | 2020-11-20 |
| Retention Device, Suture | KGS | Class 1 | General, Plastic Surgery | No | 2013-06-27 |
| Instrument, Surgical, Disposable | KDC | Class 1 | General, Plastic Surgery | No | 2012-12-21 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2017-02-17 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2013-09-11 |
| Table And Attachments, Operating-Room | BWN | Class 1 | General, Plastic Surgery | No | 2013-10-24 |
Proprietary Names
Merit Hydrophilic Guide Wire
Ventrax Delivery System
TruCut 18Ga
MultiPlex II Controller
Activation Element, ERx bone cement
Aerosizer
Impress UAC Catheter
K08 Fluid Management Kit
K04 - Tubing Kit
Pinvise Torque Device
SeaDragon Torque Device
HeartSpan Steerable Sheath Introducer
DriPAD Super Absorbent Pad
InQwire Amplatz Super Stiff Guide Wire
AEROmini Tracheobronchial Stent System
STATSEAL
WOUNDSEAL
DualCap Solo
DualCap
DualCap Duo
DualCap IV Pole Strips
Dark Blue Cap for Male Luers
Prelude Sheath Introducer
PreludeEASE Hydrophilic Sheath Introducer, 4F-6F
Merit PAK
SPINR High-Performance Guidewire Catheter
VertecoR Bone Drill, 3
Osseoflex Straight Hand Drill
Preston Transpedicular Drill
Preston Hard Bone Introducer
Preston Long Drill
MiniStop Filter Closed Waste Basin
Merit Pursue Microcatheter
Elation Fixed Wire Balloon
Elation5 Wireguided Balloon
Elation5 Fixed Wire Balloon
Torpedo Gelatin Foam
Maestro Microcatheter
Valve Adapter
Prelude SNAP 165 Valved Splittable Sheath Introducer
SCOUT Console and Accessory Cart
Osseoflex SB Steerable Balloon (10Ga)
Dash 9F Hydrophilic Sheath Introducer
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
Pressure Tubing
Squirt Fluid Delivery System
Merit Drainage Depot
Peritoneal Dialysis Catheter Connector
Aspira Peritoneal Drainage System
Stylette (rod obturator)
SCOUT Bx Delivery System
Medallion Syringe
K01 Kit (MSS)
Spectranetics
K02 Syringe Kit (multiple K01))
Temno Original
Temno ACT
Novatome Endomyocardial Biopsy Forceps
K20 Endoscopic Kit
BRC-BAL-INT-FL/A
K20T - Endoscopic Kit
ReSolve Non-Locking Drainage Catheter
ReSolve Locking Drainage Catheter
One-Step Centesis Catheter
FastBreak Connector
Cen-Step Centesis Catheter
Duramax
ClariVein IC Infusion Catheter
EvenMore Chronic Hemodialysis Catheter
Merit Syringe
Insufflation Set
ARC Catheter
Osseoflex SB Steerable Balloon (8ga)
Merit CentrosFLO Long-Term Hemodialysis Catheter
Merit Centros Long-Term Hemodialysis Catehter
Advance Angiographic Needle
Majestik Angiographic Needle
Transseptal Needle,HeartSpan Transseptal Needle&Stylet Set,TSX Transseptal Needle,Transseptal Needle&Stylet Set;et al.
PreludeEASE Hydrophilic Sheath Introducer, 7F
Temno Evolution
Critiflo Disposable Diaphragm Dome
Rad Rest
Flex-Neck Infant Catheter
PreludeSYNC DISTAL Radial Compression Device
PreludeSYNC EVO Radial Compression Device
Connecta PE Lines
StabiliT Introducer and Delivery Instruments
Maxxwire
EN Snare Endovascular Snare System
VACLOK Syringe
K02 Syringe Kit (multiple K01)
TruCut 14Ga
S-MAK XL
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
Merit 20 mL Syringe (COP)
K01 Syringe Kit (1mL & 20mL COP)
Fountain ValveTip Infusion Catheter
BowTie Guide Wire Insertion Device
Spectraject Control Syringe
Merit Administration Set
CT Transfer Set
Impress and Impress Legato Hydrophilic Angiographic Catheter
Aero DV Tracheobronchial Stent System
Hydrophilic Guidewire
K10 Waste Management Kit
K10T - Waste Management Kit
Roadster Guide Sheath
ROSE
Critikit Plus In-Line Room/ Ice Injectate
ASAPLP Embolectomy Catheter
SCOUT MD Console
SCOUT MD Delivery System
SCOUT MD Guides
SCOUT MD Single-Use Handpieces
Prelude Short Sheath Introducer
Careflow Central Venous Catheter
Surfacer Inside-Out Access Catheter System
SafeSafeSheath, ClassicSheath, Input SSV , Split Sheath Introducer Kit With Valve; et al.
Merit Convenience Kits
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
Prelude Wave Hydrophilic Sheath Introducer
Intellisystem Inflation Device
Fluid Dispensing Syringe
Prelude Prestige Splittable Sheath Introducer
SAVI Applicator Kit
Merit 1mL Syringe (COP)
Flex-Neck Extender/Repair Kit
Corvocet Biopsy System
TRAM-P
TRAM
C2 Cryoballoon Ablation System
Secalon T Catheter
Merit HeRO Graft
K13 Label Kit
ReSolve Biliary Locking Drainage Catheter
Temno Elite Biopsy Systems
SwiftNINJA Microcatheter
HeartSpan Steerable Introducer Sheath
Prelude SNAP Splittable Sheath Introducer
ER2 Saturate Mixing System
HeartSpan Fixed Curve Braided Transseptal Sheath, Braided Guiding Introducer, EZ Cross Introducer Kit; et al.
CardiaGuide Fixed Curve Braided Transseptal Sheath
Finale Radial Compression System
RADstat Radial Artery Compression Device
Vessel Dilator
DiamondTOUCH Inflation Device and Fluid Dispensing Syringe
DTX Disposable Temperature Probe
DTX/DTX Plus Kit and Accessories
DTX Plus Disposable Pressure Transducer
SwiftNINJA Steerable Microcatheter
Aspira Pleural Drainage System
Pressure Infusor Bags (PIB)
K14 Dialysis Kit
Aero Tracheo Stent and Delivery System
Concierge Guiding Catheter
PreludeSYNC EZ Radial Compression Device
SCOUT Single-Use Handpiece, SCOUT Surgical Guides
SCOUT Reflector and Delivery Systems
SCOUT Surgical Console and SCOUT Check Console
Osseoflex SB Straight Balloon (8ga)
Merit MAK (Mini Access Kit)
Merit S-MAK (Stiffened Mini Access Kit)
Safety Paracentesis Tray (SPPT)
Drainage Tubing
EmboGold Microspheres
Corvocet Coaxial Introducer
Excite Contrast Injection Line
Merit Pressure Monitoring Tubing
Merit High Pressure Tubing
Impress with Legato Hydrophilic Coating
Miser Contrast Management System
basixCompak Analog Inflation Syringe
basixTOUCH
BIG60
basixTOUCH40 Inflation Syringe
BIG60 ALPHA Inflation Devie
basixSKY Inflation Device
Safedraw Blood Sampling System
SpineSTAR Ablation Instruments
STAR Tumor Ablation Kit with PowerCURVE
STAR Tumor Ablation Kit and Accessories
MetaSTAR RF Generator
Performa Diagnostic Intravascular Catheter
Preston Transpedicular Introducer
Preston Hard Bone Access Needle with Drill
Preston Bone Filler
InQwire Diagnostic (Support) Non-Vascular Guide Wire
Prelude IDeal Hydrophilic Sheath Introducer
Tubing, Fluid Delivery
Safeguard Pressure Assisted Device (12cm)
Guidewire with Palladium Tip
Micro Ace Gold Advanced Micro Access System
Faller Trocar
Wrapsody Cell-Impermeable Endoprosthesis
Prelude Sheath Half Size (ACT)
Meritrans ECO Reusable Pressure Transducer and Meritrans ECO Disposable Domes
Straightline Osteotome, VerteCOR Midline Osteotome
PowerCURVE Navigating Osteotome
Micro Plug Set
QuadraSphere Q2 Microspheres
QuadraSphere Microspheres
Thoracentesis Tray (TAPS)
Universal Coaxial Needles
HeRO Graft
Alimaxx E
Exacta Percutaneous Sheath Introducer
InQwire Guidewires
Repositional Chest Tube
RTT14038MB
Merit Disposal Depot
Osseoflex SN
Osseoflex SN+ Needle
Osseoflex SN Needle
Osseoflex Access Kit
ReSolve Dilators
Non-vascular tissue dilators
DuraFlow 2 Hemodialysis Catheter
K16 Microcatheter Kit
RXP (Rapid Exchange Flushing Syringe)
Bath Probe
Catheter Connection Cables and Cardia Computer
Injectate Sensor Cable
Sidecar External Working Channel (FG-1011)
Elation Pulmonary Balloon
InQwire
Merit InQwire® Amplatz Super Stiff Guide Wire
FlowGuard
Micro Ace Advanced Micro Access System
Embedding Tool
ReSolve ConvertX Biliary Stent System
Merit Safety Needle
Coronary Control Syringe
K06 Syringe Kit (single CSS)
K07 Syringe Kit (multiple K06)
BioSentry Tract Sealant System
SafeGuard Focus Compression Device
SafeGuard Focus Cool Device
Resilience Fully Covered Esophageal Stent System
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
OuTake Catheter Extractor
OneSnare Endovascular Snare System
CentrosFLO Long-Term Hemodialysis Catheter
Centros Long-Term Hemodialysis Catheter
One-Vac Evacuated Drainage Bottle
VacLok AT Syringe
C2 Cryoballoon Endogrip
Elation Pulmonary Balloon 4mm
Osseoflex SB Straight Balloon (10ga)
Revolution Catheter Securement Dev.
Safeguard Radial Compression Device
Brochoalveloar Lavage (BAL) Custom Convenience Kit
ReSolve ConvertX Nephroureteral Stent System
Sterilized Convenience Kits
S-MAK
Meritrans Disposable Transducer
Acutiy Universal Cutter
Mighty Wire
H20 Guidewire
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
Low Profile Companion Sheath
Fountain 4F Catheter & Occluding GW
SafeGuard Focus Compression Device (Adhesive Free)
SafeGuard Focus Cool Device (Adhesive Free)
Solo Pace Fusion System (SOLOFUSE1)
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)
EndoMAXX
Critiflo Dome
Critiflo
Siege Vascular Plug
K18 Sheath Introducer Kit (Ease)
K15 Sheath Introducer Kit
K21 Sheath Introducer Kit (IDeal)
Smart Tip Control Syringe
SCOUT MD Single-use Handpieces
PinVise Torque Device
Fountain Catheter/Occluding Guide Wire
Softouch Diag. Intra Cath. w/Vessel
Vessel Sizing Catheter (VSC)
Bulldog Lead Extender
Contamination Sleeve, Cutter, Worley Slitter, Transavalvular Insertion Tool (TVI)
One-Tie Compression Coil
Lead Clippers
Worley
Impress Angiographic Catheter
Quick Silver
HeartLight Deflectable Sheath
Physiological Reusable Pressure Transducer
Integral Injectate Temperature Probe
Catheter Connection Cable
Disposable In Line Sensor Housing
Hydrophilic Prelude SNAP Splittable Sheath Introducer
Adjustable Biopsy Port Seal BPS-A
Achieve
Pink Achieve
EsophyX Z+ Device
Embosphere Microspheres
Emboshpere PRO
Arcadia Balloon Catheter
KYPHON KyphoFlex Balloon Catheter Kit
KYPHON KyphoFlex Balloon Catheter
Arcadia Balloon Catheter Kit
K11 Pressure Monitoring Kit
K17 Interventional Kit
K09 Manifold Kit
K17T - Interventional Kit
K09T - Manifold Kit
Futura Safety Scalpel
ViaVerte RF Generator
ViaVerte Steerable RF Ablation Kit
Safeguard Pressure Assisted Dressing (24cm)
SAVI Prep Device
SAVI Spacer
Monarch Syringe Fluid Dispense System
Prelude Plastic Jacketed Guide Wire
PAL (Pen and Labels) Family
True Form Reshapable Guide Wire
Ostial Pro Stent Positioning System
BioFlo Duramax
ExxTended Catheter
Go2Wire Guide Wire
Osseoflex CD-H Hydraulic Cement Delivery System
Elation Wireguided Balloon
Solo Pace Control
ASAP Aspiration Catheter
ASAPLP Aspiration Catheter
K01 Syringe Kit (1mL Polypropylene)
1 mL syringe(Polypropylene)
Introducer Needle WithTrocar Stylet
MAK-NV Non-Vascular
Merit Triboglide Syringe
Pericardiocentesis Catheter Kit
Slip-Not
Perchik Button Assembly
Cuff Implantor
SafT Needle Direct Blood Transfer
Flex-Neck Catheter
StayFix Fixation Device
SureCross Support Catheter
ASAP Catheter
SafeSheath CSG Introducer Sheath Kit , Worley Advanced CSG , Worley Advanced LVI Lateral Vein Introducers, et al.
ProGuide Long Term Hemodialysis Catheter
5.5 F Worley Advanced LVI Lateral Vein Introducer
Monarch Compak Inflation Syringe
Blue Diamond Inflation Syringe
Rad Trac
Rad Board Xtra
Rad Board
Rad Board 2 Reusable Arm Board
One Snare Endovascular Snare System ONE1501
Fountain Infusion Catheter w/ Occluding Guide Wire
Fountain Infusion System
Establishment Types
Export Device to the United States But Perform No Other Operation on Device