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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Hemodialysis, Implanted | MSD | Class 2 | Gastroenterology, Urology | No | 2023-06-08 |
| Mechanical Thrombolysis Catheter | QEY | Class 2 | Cardiovascular | No | 2016-11-09 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2016-01-13 |
| Prosthesis, Esophageal | ESW | Class 2 | General, Plastic Surgery | No | 2011-09-02 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2015-10-09 |
| Dilator, Vessel, For Percutaneous Catheterization | DRE | Class 2 | Cardiovascular | No | 2023-10-09 |
| System, Applicator, Radionuclide, Remote-Controlled | JAQ | Class 2 | Radiology | No | 2018-11-28 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2016-08-05 |
| Unit, Filter, Membrane | JRL | Class 1 | Clinical Chemistry | No | 2013-12-06 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2007-12-07 |
| Mixer, Cement, For Clinical Use | JDZ | Class 1 | Orthopedic | No | 2016-08-05 |
| Fluid Drainage Tray | PXU | Class 1 | General, Plastic Surgery | No | 2020-11-20 |
| System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment | PFV | Class 3 | Unknown | No | 2024-12-20 |
| Marker, Radiographic, Implantable | NEU | Class 2 | General, Plastic Surgery | No | 2026-04-28 |
| Catheter, Continuous Flush | KRA | Class 2 | Cardiovascular | No | 2020-08-07 |
| Dilator, Catheter | GCC | Class 1 | General, Plastic Surgery | No | 2014-07-02 |
| Catheter, Peritoneal, Long-Term Indwelling | FJS | Class 2 | Gastroenterology, Urology | No | 2012-12-21 |
| Catheter, Embolectomy | DXE | Class 2 | Cardiovascular | No | 2010-08-11 |
| Biopsy Needle | FCG | Class 2 | Gastroenterology, Urology | No | 2018-03-15 |
| Injector And Syringe, Angiographic | DXT | Class 2 | Cardiovascular | No | 2023-03-31 |
| Aspiration Thrombectomy Catheter | QEZ | Class 2 | Cardiovascular | No | 2013-12-05 |
| Stylet, Catheter | DRB | Class 2 | Cardiovascular | No | 2026-03-04 |
| Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | DTL | Class 2 | Cardiovascular | No | 2015-10-14 |
| Hemostatic Wound Dressing Without Thrombin Or Other Biologics | QSY | Class U | Unknown | No | 2025-06-02 |
| Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | LJS | Class 2 | General Hospital | No | 2016-02-09 |
| Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | DSY | Class 2 | Cardiovascular | No | 2016-02-09 |
| Stylet, Surgical, General & Plastic Surgery | GAH | Class 1 | General, Plastic Surgery | No | 2017-07-27 |
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 2013-10-24 |
| Clamp, Vascular | DXC | Class 2 | Cardiovascular | No | 2013-10-25 |
| Reverse Central Venous Recanalization System | QJH | Class 2 | Cardiovascular | No | 2023-06-14 |
| Device, Intravascular Catheter Securement | KMK | Class 1 | General Hospital | No | 2006-02-14 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2015-08-26 |
| Transducer, Blood-Pressure, Extravascular | DRS | Class 2 | Cardiovascular | No | 2007-12-07 |
| Catheter, Peritoneal | GBW | Class 1 | General, Plastic Surgery | No | 2014-03-21 |
| Dispenser, Cement | KIH | Class 1 | Orthopedic | No | 2017-07-27 |
| Angiography/Angioplasty Kit | OEQ | Class 2 | Cardiovascular | No | 2018-08-01 |
| Cement, Bone, Vertebroplasty | NDN | Class 2 | Orthopedic | No | 2016-08-05 |
| Agents, Embolic, For Treatment Of Uterine Fibroids | NAJ | Class 2 | Cardiovascular | No | 2013-06-20 |
| Device, Vascular, For Promoting Embolization | KRD | Class 2 | Cardiovascular | No | 2013-06-20 |
| Table And Attachments, Operating-Room | BWN | Class 1 | General, Plastic Surgery | No | 2013-10-24 |
| Bulb, Inflation, For Endoscope | FCY | Class 1 | Gastroenterology, Urology | No | 2012-12-21 |
| Dialysis Administration Kit | PEV | Class 2 | Gastroenterology, Urology | No | 2018-08-01 |
| Vacuum Syringe | PUR | Class 2 | General Hospital | No | 2017-07-28 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2007-12-07 |
| Minor Surgical Procedures Tray | PYB | Class 1 | General, Plastic Surgery | No | 2018-08-01 |
| Prosthesis, Tracheal, Expandable | JCT | Class 2 | General, Plastic Surgery | No | 2014-12-09 |
| Absorbable Lung Biopsy Plug | OMT | Class 2 | General, Plastic Surgery | No | 2023-06-08 |
| Cart, Emergency, Cardiopulmonary (Excluding Equipment) | BZN | Class 1 | Anesthesiology | No | 2021-01-27 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2013-01-17 |
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter | OAD | Class 3 | Unknown | No | 2021-05-12 |
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2018-04-02 |
| Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | KNS | Class 2 | Gastroenterology, Urology | No | 2010-12-13 |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | Class 2 | Gastroenterology, Urology | No | 2019-07-12 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2020-09-09 |
| Bronchoscope Accessory | KTI | Class 2 | Ear, Nose, Throat | No | 2016-09-06 |
| Endoscopic Irrigation/Suction System | OCX | Class 2 | Gastroenterology, Urology | No | 2026-05-08 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2018-04-02 |
| Probe, Radiofrequency Lesion | GXI | Class 2 | Neurology | No | 2026-04-16 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2026-04-16 |
| Catheter, Thrombus Retriever | NRY | Class 2 | Cardiovascular | No | 2024-08-19 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2018-12-21 |
| Device, Measuring, For Panendoscope | FDY | Class 1 | Gastroenterology, Urology | No | 2009-06-11 |
| Unit, Cryosurgical, Accessories | GEH | Class 2 | General, Plastic Surgery | No | 2026-05-08 |
| Retention Device, Suture | KGS | Class 1 | General, Plastic Surgery | No | 2013-06-27 |
| Catheter, Peritoneal Dialysis, Single Use | FKO | Class 2 | Gastroenterology, Urology | No | 2012-12-21 |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | Class 2 | Gastroenterology, Urology | No | 2014-02-14 |
| Tubing, Fluid Delivery | FPK | Class 2 | General Hospital | No | 2007-12-19 |
| Cardiovascular Catheter Sheath Introducer Kit | OEX | Class 2 | Cardiovascular | No | 2018-08-01 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2019-11-05 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2019-11-05 |
| Accessories, Catheter | KGZ | Class 1 | General, Plastic Surgery | No | 2003-12-18 |
| Device, Percutaneous Retrieval | MMX | Class 2 | Cardiovascular | No | 2020-01-20 |
| Intravenous Extension Tubing Set | OJA | Class 2 | General Hospital | No | 2018-07-17 |
| Apparatus, Suction, Patient Care | DWM | Class 2 | Cardiovascular | No | 2023-04-04 |
| Universal Drainage Tray | PPD | Class 2 | Gastroenterology, Urology | No | 2018-08-01 |
| Syringe, Balloon Inflation, Exempt | PTM | Class 2 | Cardiovascular | No | 2017-07-27 |
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | Class 2 | Gastroenterology, Urology | No | 2026-05-08 |
| Dilator, Esophageal | KNQ | Class 2 | Gastroenterology, Urology | No | 2015-05-01 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2009-06-11 |
| Instrument, Surgical, Disposable | KDC | Class 1 | General, Plastic Surgery | No | 2012-12-21 |
| Dressing, Compression | MHW | Class 1 | General Hospital | No | 2020-09-09 |
| Bone Cement | LOD | Class 2 | Orthopedic | No | 2017-07-27 |
| Syringe, Balloon Inflation | MAV | Class 2 | Cardiovascular | No | 2007-12-07 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2013-06-11 |
| Single Use Instrument Tray | OJV | Class 1 | General, Plastic Surgery | No | 2015-05-18 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2001-07-14 |
| Paracentesis Tray | PYC | Class 1 | General, Plastic Surgery | No | 2023-03-10 |
| Peripheral Catheter Insertion Kit | OWL | Class 2 | General Hospital | No | 2018-08-01 |
| Cardiovascular Procedure Kit | OEZ | Class 2 | Cardiovascular | No | 2018-08-01 |
| Stent, Ureteral | FAD | Class 2 | Gastroenterology, Urology | No | 2019-07-12 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2017-11-15 |
| Label Or Tag, Sterile | LYV | Class 1 | General, Plastic Surgery | No | 2008-10-09 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2007-12-07 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2003-12-18 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2013-09-11 |
| Tunneled Catheter Remover | ODY | Class 2 | General Hospital | No | 2009-02-20 |
| Needle, Catheter | GCB | Class 1 | General, Plastic Surgery | No | 1992-07-14 |
| Infusor, Pressure, For I.V. Bags | KZD | Class 1 | General Hospital | No | 2003-12-18 |
| Cap, Device Disinfectant | QBP | Class 2 | General Hospital | No | 2017-03-01 |
| System, Peritoneal, Automatic Delivery | FKX | Class 2 | Gastroenterology, Urology | No | 2012-12-21 |
| Injector, Vertebroplasty (Does Not Contain Cement) | OAR | Class 1 | Orthopedic | No | 2013-11-11 |
| Thoracentesis Tray | PXI | Class 2 | General Hospital | No | 2023-05-19 |
| Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling | PNG | Class 2 | Gastroenterology, Urology | No | 2020-09-02 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2008-04-11 |
| Electrode, Pacemaker, Temporary | LDF | Class 2 | Cardiovascular | No | 2026-04-14 |
| Bag, Bile Collecting | EXF | Class 2 | Gastroenterology, Urology | No | 2017-07-24 |
| Device, Biopsy, Endomyocardial | DWZ | Class 2 | Cardiovascular | No | 2025-01-22 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2016-08-05 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2003-06-05 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2012-09-04 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2003-06-05 |
| Pulse-Generator, Pacemaker, External | DTE | Class 2 | Cardiovascular | No | 2026-04-14 |
| Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd) | ODE | Class 2 | Gastroenterology, Urology | No | 2024-07-31 |
| Catheter, Steerable | DRA | Class 2 | Cardiovascular | No | 2017-06-30 |
| Bottle, Collection, Vacuum | KDQ | Class 2 | General Hospital | No | 2021-06-23 |
| Trocar | DRC | Class 2 | Cardiovascular | No | 2007-12-07 |
| Needle, Biopsy, Cardiovascular | DWO | Class 1 | General, Plastic Surgery | No | 2018-07-19 |
| Tourniquet, Pneumatic | KCY | Class 1 | General, Plastic Surgery | No | 2016-03-30 |
| Endoscope Introducer Kit | NWU | Class 2 | Gastroenterology, Urology | No | 2018-08-01 |
| Wire, Guide, Catheter, Exempt | PTL | Class 2 | Cardiovascular | No | 2017-07-27 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2018-03-27 |
| Endoscopic Guidewire, Gastroenterology-Urology | OCY | Class 2 | Gastroenterology, Urology | No | 2024-03-08 |
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