BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ARGON MEDICAL DEVICES, INC.

    Reg #: 1417485 · FEI: 1417485 · Expires 2026
    View on FDA
    Products
    34
    Proprietary Names
    111
    Establishment Types
    3
    Classifications
    34

    Registration Details

    Registration Name
    ARGON MEDICAL DEVICES, INC.
    Registration Number
    1417485
    FEI Number
    1417485
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    241 W Palatine Rd
    City
    WHEELING
    State
    IL
    ZIP
    60090
    Country
    US

    Regulatory Submissions

    510(k) Number
    K883744

    Owner / Operator

    Firm Name
    ARGON MEDICAL DEVICES, INC
    Operator Number
    9059795
    Address
    1445 FLAT CREEK ROAD, --
    City
    Athens
    State
    TX
    Postal Code
    75751
    Country
    US
    Correspondent
    Scott Bishop

    Products

    Device Name Product Code
    Orthosis, Spinal Pedicle Fixation MNI
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Needle, Hypodermic, Single Lumen FMI
    Syringe, Piston FMF
    Instrument, Biopsy KNW
    Introducer, Catheter DYB
    Filler, Bone Void, Calcium Compound MQV
    Source, Brachytherapy, Radionuclide KXK
    Catheter, Nephrostomy, General & Plastic Surgery GBO
    Needle, Aspiration And Injection, Disposable GAA
    System, Applicator, Radionuclide, Remote-Controlled JAQ
    Cannula, Manipulator/Injector, Uterine LKF
    Stents, Drains And Dilators For The Biliary Ducts FGE
    Catheter, Continuous Irrigation GBQ
    Instruments, Surgical, Cardiovascular DWS
    Wire, Guide, Catheter DQX
    Cannula, Catheter DQR
    Trocar DRC
    Biopsy Needle FCG
    Device, Percutaneous, Biopsy MJG
    Marker, Radiographic, Implantable NEU
    Needle, Conduction, Anesthetic (W/Wo Introducer) BSP
    Set, Administration, Intravascular FPA
    System, Applicator, Radionuclide, Manual IWJ
    Accessories, Catheter KGZ
    Needle, Biopsy, Cardiovascular DWO
    Cannula, Surgical, General & Plastic Surgery GEA
    Spinal Channeling Instrument, Vertebroplasty OCJ
    Mixer, Cement, For Clinical Use JDZ
    Needle, Catheter GCB
    Needle, Aspiration And Injection, Reusable GDM
    Orthopedic Manual Surgical Instrument LXH
    Anesthesia Conduction Kit CAZ
    Injector, Vertebroplasty (Does Not Contain Cement) OAR

    Proprietary Names

    Galactography Kits 16GA High Flow Needle Huber Style Infusion Needle Tru-Core I EURO Biopsy Needles Tru-Core Auto Biopsy Needles T-Lab Techna-Cut Biopsy Needle Skater Nephrostomy Drainage Catheter w/ Locking Pigtail Spinal Style Needle Comfort Catheter System HSG Catheters, HSG Procedure Tray D Wire Breast Localization Needles Accura II Breast Localization Needles (Sadowsky Style) Accura Breast Localization Needles Clearview Plus Bone and Vertebral Body Biopsy Needles Hawkins Blunt Needles MANAN BREAST LOCALIZATION NEEDLE Skater Billiary Drainage Catheter Co-Axial Introducer Needle Abrivo Introducer Skater Single Step Drainage Catheter Skater Drainage Catheter Skater Centesis Catheter Skater All Purpose Drainage Catheter Skater All Purpose and Nephrostomy Drainage Catheter Skater Mini-Loop Tru-Core II URO Automatic Biopsy Instruments Greene Style Biopsy Needle Pinnacle Precision Access System Osteo-Site Bone Biopsy Needle Glidesheath GWI Needle Westcott Soft Tissue Biopsy Needle Micro Access Sets SABD Access Needle Echo-Coat Super Core II Biopsy Instruments iVAS 13g Bone Biopsy Kit SmartClip Soft Tissue Marker Epidural Needle Bio-Cut Biopsy Instrument Blunt Needle Co-axial Needle Prostate Stablization Needles Prostate Seeding Sets Seed Selectron Model V. 1 Brachytherapy Planning System Introducer Sheath Needles ACN, SACN, Biopsy Needle Homer Breast Localization Needles Microlite Disposable Suction Needle Access needles Co-axial Introducer Needles 11 guage Bone Access Needles Coaxial Access System Hard Introducer (6 & 11cm) Coaxial Access System Soft Introducer (10, 13 & 23cm) Peritoneal Lavage drainage needle/catheter Connecting tubes for drainage catheters Catheter securement device SKATER Fix Super Core Biopsy Needle MANAN SPINAL AND EPIDURAL NEEDLES Manan Spinal Needles Techna-Cut Ultra-Core Biopsy Needles Franseen Biopsy Needle Pro-Mag Ultra 2.2 Automatic Biopsy Instrument Pro-Mag Ultra Biopsy Needles, Pro-Mag Ultra Automatic Biopsy Instrument Coaxial Introducer Introducer Cannula / Needle Trocar Needle Chiba Style Needle Epidural Needle (Catheter Accessories) Hawkins III Breast Localization Needle w/ Hardware Hawkins II Breast Localization Needles w/ Flexstrand Hawkins II Breast Localization Needle w/ Hardware Hawkins III Breast Localization Needle w/ Echogenic Tip and Hardwire Hawkins I Breast Localization Needles Hawkins III Breas Localization Needle w/ Flexstrand Tru-Core III Semi-Automatic Biopsy Instruments VAS Bone Biopsy Kit OptiMesh Instruments Pin Introducer JAM SHIDI 11GAUGE 5 INCH Capture Facet Fixation System XIA Precision JAM SHIDI 10GAUGE 5 INCH JAM SHIDI 13GAUGE 5 INCH JAM SHIDI 10GAUGE 9 INCH Kuske Breast Applicator Set Model 18906 Bone Marrow "I" & "J" Pediatric Bone Marrow Access Teleflex Epidural Needle Bone Marrow Harvest Needle The Extractor Westcott Soft Tissue Biosy Needles Franseen Trocar MaxiCELL Green Turner Fine Needle Aspiration (FNA) Biopsy Needles Chiba Spinal Pro-Cut Bone Marrow Harvest Needles Bone Marrow Aspiration Needles T-Lok Bone Marrow Biopsy Needles OSTY-CORE BONE BIOPSY NEEDLES Pediatric Bone Marrow Access Needles Bone Marrow Biopsy Trays Skater Introducer Sets

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device Repack or Relabel Medical Device