Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1417485

FEI Number

1417485

Entity Name

ARGON MEDICAL DEVICES, INC.

City/State/Country

WHEELING, IL, US

Establishment Address

241 W Palatine Rd, WHEELING, IL 60090, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ARGON MEDICAL DEVICES, INC (Owner Number: 9059795)

Owner / Operator Contact Address

1445 FLAT CREEK ROAD, --, Athens, TX 75751, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 Access 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2016-03-14
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2016-03-14
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2013-04-18
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2013-04-22
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2013-04-22
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2013-04-18
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2015-02-17
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2013-04-18
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2016-11-02
KXK	Source, Brachytherapy, Radionuclide	Radiology	Class 2	892.5730	2013-04-22
GBO	Catheter, Nephrostomy, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4200	2013-04-18
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2013-04-22
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2013-04-22
LKF	Cannula, Manipulator/Injector, Uterine	Obstetrics/Gynecology	Class 2	884.4530	2013-04-18
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2015-10-20
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2013-04-18
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2013-04-22
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2013-04-18
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2013-04-22
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2013-04-18
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2013-04-18
GBQ	Catheter, Continuous Irrigation	General, Plastic Surgery	Class 1	878.4200	2013-04-18
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2013-04-18
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2013-06-04
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2018-05-24
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2018-06-08
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2013-04-22
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2018-05-24
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2013-04-22
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2013-06-04
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2013-04-22
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2013-04-22
DQR	Cannula, Catheter	Cardiovascular	Class 2	870.1300	2013-04-22
DRC	Trocar	Cardiovascular	Class 2	870.1390	2013-04-22
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2015-02-17
MJG	Device, Percutaneous, Biopsy	General, Plastic Surgery	Class 1	878.4800	2013-04-18
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2013-04-18
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2026-02-17
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2019-04-08
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2013-04-22
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2013-04-22
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2013-04-22
MJG	Device, Percutaneous, Biopsy	General, Plastic Surgery	Class 1	878.4800	2013-04-22
IWJ	System, Applicator, Radionuclide, Manual	Radiology	Class 1	892.5650	2013-04-18
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2013-04-22
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2013-04-22
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2013-04-18
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2013-04-19
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2013-06-28
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2013-04-22
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2013-04-22
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2013-04-22
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2013-04-22
DWO	Needle, Biopsy, Cardiovascular	General, Plastic Surgery	Class 1	878.4800	2013-04-18
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2013-06-04
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2013-04-18
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2013-04-22
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2024-08-07

Official Correspondent

Scott Bishop

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ARGON MEDICAL DEVICES, INC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1625425	ARGON MEDICAL DEVICES INC.	ATHENS, TX, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K012175	Encore Orthopedics, Inc.	PASS SPINAL SYSTEM	2001-07-31
K032752	R&B Surgical Solutions, LLC	R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM	2003-12-03
K062643	Life Spine	KINETIC ANTERIOR CERVICAL PLATE	2006-11-16
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0036-2013	Medtronic Sofamor Danek USA Inc	2	ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0037-2013	Medtronic Sofamor Danek USA Inc	2	ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0038-2013	Medtronic Sofamor Danek USA Inc	2	PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0040-05	Zimmer Spine, Inc.	2	ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays.
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1417485. Last updated year: 2026. Please use registration number 1417485 when referencing this establishment in official correspondence.