MedXL

FDA Device Registration & Listing · ARDMORE, OK, US · Registration 1644312

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1644312
FEI Number
1000117748
Entity Name
MedXL
City/State/Country
ARDMORE, OK, US
Establishment Address
3204 Hale Rd, ARDMORE, OK 73401, US
Establishment Type(s)
Sterilize Medical Device for Another Party (Contract Sterilizer)
Owner / Operator
MEDXL (Owner Number: 10089418)
Owner / Operator Contact Address
3204 Hale Road, Ardmore, OK 73401, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

ADVANCE DISPOSABLE CONTROL SYRINGE EASY PASS HYDROPHILIC COATED VASCULAR GUIDEWIRE GALT MEDICAL GUIDEWIRE MANAN BREST TUMOR LOCALIZATION NEEDLE OPTICAL INTEGRITY GENERAL SHAPED FIBER iVAS 8g Bone Biopsy Kit, iVAS 11g Bone Biopsy Kit, iVAS 10g Bone Biopsy Kit Cypris Medical eXact 5 Suture Placement Device CM3051 - Cypris Medical eXact 5.1 Suture Placement Device N-TERFACE IGNITE BONE VOID FILLER KIT CRYOBAG, MODEL CB K782006 GaltTWS Flask, tissue culture Attachable Cath Lab Hemostasis Valve Coaxial Dilator Set (Micro-Introducer) ATRION MEDICAL QL INFLATION DEVICE MEDSURG EQUIPMENT COVERS MEDGENERAL SINGLE-USE BULLDOG MANAN(TM) SUPER-CORE BIOPSY NEEDLES Urine collection bag, external, sterile, for leg Clamp Galt Tork, 010 to 020 inches (yellow), Galt Tork, 025 to 040 inches (orange) MANAN ACCURA NEEDLE SEED SELECTRON MODEL V. 1 TEARAWAY INTRODUCER SHEATH SmartClip Soft Tissue Marker TECHNA-CUT ASPIRATION NEEDLE INSTRUMENT, SURGICAL, DISPOSABLE HydroPICC 5F Dual Lumen Catheter FIRST PICC CATHETER WITH DUAL LUMENS TRU-CORE I REUSABLE BIOPSY INSTRUMENT CENTRAL CATHETER KIT CONTAINER, SPECIMEN, STERILE COAXIAL DILATOR SET ULTRASTREAM CHRONIC HEMODIALYSIS CATHETER FIRST PICC CATHETER MANAN EPIDURAL NEEDLE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT MANAN SUPER-CORE BIOPSY NEEDLE Cleaner Plus Thrombectomy System Mikro-Cath Pressure Catheter spinal channeling instrument, vertebroplasty MANAN GREENE NEEDLE CATHETER INTRODUCER STOPCOCK, ONE WAY Bile collecting bag MEICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSABLE AUTOMATIC BIOPSY INSTRUMENT ARGON CONTINUOUS FLUSH DEVICE HAWKINS-AKINS BLUNT NEEDLE ACCESS KIT MANAN CHIBA PTC NEEDLE MANAN SPINAL NEEDLE HydroMID Occulsive wound dressing GALT MEDICAL GUIDEWIRE GUIDEWIRE FIRST MIDCATH CATHETER DESERET INTRACATH INTRAVENOUS CATHETER MD TECH BIOPSY SET FOR BONE AND BONE MARROW MEDICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSALE SEMI-AUTOMATIC BIOPDY INSTRUMENT TRIV(TM) VALVED TEARAWAY INTRODUCER, TIRV(TM) VALVED TEARAWAY INTRODUCER WITH SIDE PORT NUCLETRON COMFORT CATHETER SYSTEM, MODEL 18907 MANAN BLUNT NEEDLE PENCIL POINT NEEDLE MANAN AUTOMATIC CUTTING NEEDLE Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set FLEXIBLE SPINAL NEEDLE CLEARVIEW PLUS BONE AND VERTEBRAL BODY BIOPSY NEEDLES ELCAM STOPCOCKS AND MANIFOLDS KUSKE BREAST APPLICATOR SET, MODEL 18906 SAFEWEDGE(TM) RELIEF VALVE DEVICE CATHETER, CONTINUOUS IRRIGATION NON-CORING NEEDLE System/device, pharmacy compounding ECHO-COAT ULTRASOUND NEEDLES L-CATH PEEL AWAY SYSTEM CATHETER Sterile Dilator MANAN HUBER STYLE INFUSION NEEDLE MANAN WESTCOTT NEEDLE STERILE EQUIPMENT COVER MANAN TROCAR STYLE BIOPSY NEEDLE MIXER, CEMENT, FOR CLINICAL USE MANAN SOFT TISSUE BIOPSY NEEDLES MANAN GENERAL PURPOSE INTRODUCER NEEDLE MANAN PEDIATRIC BONE MARROW ACCESS NEEDLE Catheter adapter STINGRAY EPIDURAL CATHETER CONNECTOR FETH-R-KATH EXTENSION SET, MODELS 1911-512 MANAN PROSTATE SEEDING NEEDLE MICROSLIDER TEARAWAY INTRODUCER SET GALTSTICK INTRODUCER SYSTEM RK EPIDURAL NEEDLE APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED LABEL OR TAG, STERILE BD L-CATH SINGLE AND DUAL LUMENT CATHETERS, MIDLINE CATHETER RX EPIDURAL NEEDLE MANAN GENERAL PURPOSE INTRODUCER NEEDLE Turbo High-Flow Non-coring Needle L-CATH MODIFIED SELDINGER TECHNIQUE INSERTION/CATHETER EXCHANGE KIT PE-MST24-24 GA. KIT, L-CATH MODIFIED SELDINGER MANAN GALACTOGRAPHY KIT URESIL NEPHRO-URETERAL STENT Shield, protective, personnel

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2023-12-08
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2023-12-08
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2023-12-08
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2023-12-08
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2023-12-08
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2023-12-08
GEJ Carrier, Ligature General, Plastic Surgery Class 1 878.4800 2024-03-13
MGP Dressing, Wound And Burn, Occlusive Unknown Class U N/A 2023-12-08
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2023-12-08
LPZ Container, Frozen Donor Tissue Storage Unknown Class U N/A 2023-12-08
GDJ Clamp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2023-12-08
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2023-12-08
DRB Stylet, Catheter Cardiovascular Class 2 870.1380 2023-12-08
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2023-12-08
KJA Flask, Tissue Culture Hematology Class 1 864.2240 2024-12-30
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2023-12-08
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2023-12-08
KOE Dilator, Urethral Gastroenterology, Urology Class 2 876.5520 2023-12-08
MAV Syringe, Balloon Inflation Cardiovascular Class 2 870.1650 2023-12-08
MMP Cover, Barrier, Protective General, Plastic Surgery Class 2 878.4370 2023-12-08
GDJ Clamp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2023-12-08
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2023-12-08
FAQ Bag, Urine Collection, Leg, For External Use, Sterile Gastroenterology, Urology Class 1 876.5250 2024-12-30
HXD Clamp General, Plastic Surgery Class 1 878.4800 2024-12-30
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2023-12-08
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2023-12-08
JAQ System, Applicator, Radionuclide, Remote-Controlled Radiology Class 2 892.5700 2023-12-08
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2023-12-08
NEU Marker, Radiographic, Implantable General, Plastic Surgery Class 2 878.4300 2023-12-08
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2023-12-08
KDC Instrument, Surgical, Disposable General, Plastic Surgery Class 1 878.4800 2024-12-30
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2023-12-08
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2023-12-08
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2023-12-08
FPK Tubing, Fluid Delivery General Hospital Class 2 880.5440 2023-12-08
FMH Container, Specimen, Sterile Pathology Class 1 864.3250 2024-12-30
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2023-12-08
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2023-12-08
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2023-12-08
GCB Needle, Catheter General, Plastic Surgery Class 1 878.4200 2023-12-08
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2024-12-30
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2023-12-08
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2023-12-08
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2023-12-08
DXO Transducer, Pressure, Catheter Tip Cardiovascular Class 2 870.2870 2023-12-08
OCJ Spinal Channeling Instrument, Vertebroplasty Orthopedic Class 1 888.4540 2024-12-30
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2023-12-08
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2023-12-08
KOC Accessories, Blood Circuit, Hemodialysis Gastroenterology, Urology Class 2 876.5820 2023-12-08
EXF Bag, Bile Collecting Gastroenterology, Urology Class 2 876.5010 2024-12-30
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2023-12-08
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2023-12-08
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2023-12-08
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2023-12-08
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2023-12-08
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2023-12-08
NAD Dressing, Wound, Occlusive General, Plastic Surgery Class 1 878.4020 2024-12-30
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2023-12-08
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2023-12-08
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2023-12-08
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2023-12-08
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2023-12-08
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2023-12-08
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2023-12-08
JAQ System, Applicator, Radionuclide, Remote-Controlled Radiology Class 2 892.5700 2023-12-08
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2023-12-08
BSP Needle, Conduction, Anesthetic (W/Wo Introducer) Anesthesiology Class 2 868.5150 2023-12-08
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2023-12-08
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2023-12-08
BSP Needle, Conduction, Anesthetic (W/Wo Introducer) Anesthesiology Class 2 868.5150 2023-12-08
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2023-12-08
FMG Stopcock, I.V. Set General Hospital Class 2 880.5440 2023-12-08
JAQ System, Applicator, Radionuclide, Remote-Controlled Radiology Class 2 892.5700 2023-12-08
KRB Probe, Thermodilution Cardiovascular Class 2 870.1915 2023-12-08
GBQ Catheter, Continuous Irrigation General, Plastic Surgery Class 1 878.4200 2024-12-30
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2023-12-08
NEP System/Device, Pharmacy Compounding General Hospital Class 2 880.5440 2024-12-30
MJG Device, Percutaneous, Biopsy General, Plastic Surgery Class 1 878.4800 2023-12-08
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2023-12-08
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2023-12-08
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2023-12-08
FMF Syringe, Piston General Hospital Class 2 880.5860 2023-12-08
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2023-12-08
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2023-12-08
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2023-12-08
JDZ Mixer, Cement, For Clinical Use Orthopedic Class 1 888.4210 2024-12-30
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2023-12-08
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2023-12-08
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2023-12-08
HOI Spectacle, Magnifying Ophthalmic Class 1 886.5840 2024-12-30
CAZ Anesthesia Conduction Kit Anesthesiology Class 2 868.5140 2023-12-08
BSO Catheter, Conduction, Anesthetic Anesthesiology Class 2 868.5120 2023-12-08
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2023-12-08
KXK Source, Brachytherapy, Radionuclide Radiology Class 2 892.5730 2023-12-08
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2023-12-08
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2023-12-08
BSP Needle, Conduction, Anesthetic (W/Wo Introducer) Anesthesiology Class 2 868.5150 2023-12-08
GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered General, Plastic Surgery Class 1 878.4680 2024-12-30
LYV Label Or Tag, Sterile General, Plastic Surgery Class 1 878.4800 2024-12-30
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2023-12-08
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2023-12-08
BSP Needle, Conduction, Anesthetic (W/Wo Introducer) Anesthesiology Class 2 868.5150 2023-12-08
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2023-12-08
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2023-12-08
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2023-12-08
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2023-12-08
LJE Catheter, Nephrostomy Unknown Class U N/A 2023-12-08
KPY Shield, Protective, Personnel Radiology Class 1 892.6500 2024-12-30

Official Correspondent

Steve Adamietz

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MEDXL
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K150445 Asahi Intecc Co., Ltd. ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV) 2015-06-30
K082922 Lake Region Mfg., Inc. FREEWAY AND RAILRUNNER GUIDEWIRES 2008-12-09
K890207 E-Z-Em, Inc. INTERVENTIONAL PRODUCTS - GUIDE WIRES 1989-05-31
K992169 Advanced Cardiovascular Systems, Inc. ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE 1999-10-28
K012534 Advanced Cardiovascular Systems, Inc. HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING 2002-01-24

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0030-2009 Boston Scientific Corporation 2
Platinum Plus" LT , REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0031-2009 Boston Scientific Corporation 2
Platinum Plus" LT , REF 46-602, UPN M001466020, LT/0.018/260, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0017-2023 Hobbs Medical, Inc. 1
Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620
Z-0018-2023 Hobbs Medical, Inc. 1
Hobbs Transbronchial Aspiration Needle Catalog Number: 4621
Z-0023-2011 Becton Dickinson & Company 1
BD 30G1/2 PrecisionGlide Needle;Catalog/Lot Number: 305106. Needles are intended for use in aspiration and injection of medications.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1644312. Last updated year: 2026. Please use registration number 1644312 when referencing this establishment in official correspondence.
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