FDA Registration
Active
🇺🇸 United States
MedXL
Reg #: 1644312
·
FEI: 1000117748
·
Expires 2026
Products
80
Proprietary Names
141
Establishment Types
1
Classifications
80
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Registration Details
- Registration Name
- MedXL
- Registration Number
- 1644312
- FEI Number
- 1000117748
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3204 Hale Rd
- City
- ARDMORE
- State
- OK
- ZIP
- 73401
- Country
- US
Owner / Operator
- Firm Name
- MEDXL
- Operator Number
- 10089418
- Address
- 3204 Hale Road
- City
- Ardmore
- State
- OK
- Postal Code
- 73401
- Country
- US
- Correspondent
- Steve T Adamietz
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, X-Ray, Angiographic | IZI | Class 2 | Radiology | No | 2023-12-08 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2023-12-08 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2023-12-08 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2023-12-08 |
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2023-12-08 |
| Carrier, Ligature | GEJ | Class 1 | General, Plastic Surgery | No | 2024-03-13 |
| Dressing, Wound And Burn, Occlusive | MGP | Class U | Unknown | No | 2023-12-08 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2023-12-08 |
| Container, Frozen Donor Tissue Storage | LPZ | Class U | Unknown | No | 2023-12-08 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2023-12-08 |
| Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | DTL | Class 2 | Cardiovascular | No | 2023-12-08 |
| Stylet, Catheter | DRB | Class 2 | Cardiovascular | No | 2023-12-08 |
| Flask, Tissue Culture | KJA | Class 1 | Hematology | No | 2024-12-30 |
| Dilator, Vessel, For Percutaneous Catheterization | DRE | Class 2 | Cardiovascular | No | 2023-12-08 |
| Dilator, Urethral | KOE | Class 2 | Gastroenterology, Urology | No | 2023-12-08 |
| Syringe, Balloon Inflation | MAV | Class 2 | Cardiovascular | No | 2023-12-08 |
| Cover, Barrier, Protective | MMP | Class 2 | General, Plastic Surgery | No | 2023-12-08 |
| Bag, Urine Collection, Leg, For External Use, Sterile | FAQ | Class 1 | Gastroenterology, Urology | No | 2024-12-30 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2024-12-30 |
| System, Applicator, Radionuclide, Remote-Controlled | JAQ | Class 2 | Radiology | No | 2023-12-08 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2023-12-08 |
| Marker, Radiographic, Implantable | NEU | Class 2 | General, Plastic Surgery | No | 2023-12-08 |
| Instrument, Surgical, Disposable | KDC | Class 1 | General, Plastic Surgery | No | 2024-12-30 |
| Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | LJS | Class 2 | General Hospital | No | 2023-12-08 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2023-12-08 |
| Tubing, Fluid Delivery | FPK | Class 2 | General Hospital | No | 2023-12-08 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2024-12-30 |
| Catheter, Hemodialysis, Implanted | MSD | Class 2 | Gastroenterology, Urology | No | 2023-12-08 |
| Needle, Catheter | GCB | Class 1 | General, Plastic Surgery | No | 2023-12-08 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2024-12-30 |
| Catheter, Continuous Flush | KRA | Class 2 | Cardiovascular | No | 2023-12-08 |
| Peripheral Mechanical Thrombectomy With Aspiration | QEW | Class 2 | Cardiovascular | No | 2023-12-08 |
| Transducer, Pressure, Catheter Tip | DXO | Class 2 | Cardiovascular | No | 2023-12-08 |
| Spinal Channeling Instrument, Vertebroplasty | OCJ | Class 1 | Orthopedic | No | 2024-12-30 |
| Accessories, Blood Circuit, Hemodialysis | KOC | Class 2 | Gastroenterology, Urology | No | 2023-12-08 |
| Bag, Bile Collecting | EXF | Class 2 | Gastroenterology, Urology | No | 2024-12-30 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2024-12-30 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2023-12-08 |
| Needle, Conduction, Anesthetic (W/Wo Introducer) | BSP | Class 2 | Anesthesiology | No | 2023-12-08 |
| Stopcock, I.V. Set | FMG | Class 2 | General Hospital | No | 2023-12-08 |
| Probe, Thermodilution | KRB | Class 2 | Cardiovascular | No | 2023-12-08 |
| Catheter, Continuous Irrigation | GBQ | Class 1 | General, Plastic Surgery | No | 2024-12-30 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2023-12-08 |
| System/Device, Pharmacy Compounding | NEP | Class 2 | General Hospital | No | 2024-12-30 |
| Device, Percutaneous, Biopsy | MJG | Class 1 | General, Plastic Surgery | No | 2023-12-08 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2023-12-08 |
| Drape, Surgical, Antimicrobial | KKX | Class 2 | General, Plastic Surgery | No | 2023-12-08 |
| Mixer, Cement, For Clinical Use | JDZ | Class 1 | Orthopedic | No | 2024-12-30 |
| Spectacle, Magnifying | HOI | Class 1 | Ophthalmic | No | 2024-12-30 |
| Anesthesia Conduction Kit | CAZ | Class 2 | Anesthesiology | No | 2023-12-08 |
| Catheter, Conduction, Anesthetic | BSO | Class 2 | Anesthesiology | No | 2023-12-08 |
| Source, Brachytherapy, Radionuclide | KXK | Class 2 | Radiology | No | 2023-12-08 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 2024-12-30 |
| Label Or Tag, Sterile | LYV | Class 1 | General, Plastic Surgery | No | 2024-12-30 |
| Catheter, Nephrostomy | LJE | Class U | Unknown | No | 2023-12-08 |
| Shield, Protective, Personnel | KPY | Class 1 | Radiology | No | 2024-12-30 |
| Tube, Gastro-Enterostomy | KGC | Class 2 | Gastroenterology, Urology | No | 2023-12-08 |
| Dislodger, Stone, Basket, Ureteral, Metal | FFL | Class 2 | Gastroenterology, Urology | No | 2024-12-30 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2023-12-08 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2023-12-08 |
| Needle, Spinal, Short Term | MIA | Class 2 | Anesthesiology | No | 2023-12-08 |
| Cannula, Manipulator/Injector, Uterine | LKF | Class 2 | Obstetrics/Gynecology | No | 2023-12-08 |
| Generator, Lesion, Radiofrequency | GXD | Class 2 | Neurology | No | 2023-12-08 |
| Probe, Radiofrequency Lesion | GXI | Class 2 | Neurology | No | 2023-12-08 |
| Injector, Vertebroplasty (Does Not Contain Cement) | OAR | Class 1 | Orthopedic | No | 2024-12-30 |
| System, Applicator, Radionuclide, Manual | IWJ | Class 1 | Radiology | No | 2023-12-08 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2024-12-30 |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | Class 1 | General, Plastic Surgery | No | 2023-12-08 |
| Catheter, Nephrostomy, General & Plastic Surgery | GBO | Class 1 | General, Plastic Surgery | No | 2024-12-30 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2024-12-30 |
| Accessories, Catheter | KGZ | Class 1 | General, Plastic Surgery | No | 2024-12-30 |
| Tube, Tissue Culture | KJG | Class 1 | Pathology | No | 2024-12-30 |
| Clamp, Vascular | DXC | Class 2 | Cardiovascular | No | 2023-12-08 |
| Sheet, Burn | FPY | Class 1 | General Hospital | No | 2024-12-30 |
| Bottle, Collection, Vacuum | KDQ | Class 2 | General Hospital | No | 2024-12-30 |
| Probe, Lachrymal | HNL | Class 1 | Ophthalmic | No | 2024-12-30 |
| Needle, Aspiration And Injection, Reusable | GDM | Class 1 | General, Plastic Surgery | No | 2023-12-08 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2024-12-30 |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | Class 2 | Gastroenterology, Urology | No | 2023-12-08 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2024-12-30 |
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
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
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
MANAN FRANSEENE NEEDLE
CENTRAL CATHETER TRAY
MANAN BIO-CUT SOFT TISSUE BIOPSY NEEDLE
STRYKER VERTEBRAL BODY AND BONE BIOPSY KITS, STRYKER CAPTURE BODY AND BONE BIOSPSY KITS
DISLODGER, STONE, BASKET, URETERAL, METAL
RANGE SPINAL SYSTEM
HydroPICC (PICC-142)
TUOHY EPIDURAL NEEDLE
FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837
GALT VTI LOW INSERTION VALVE TEARAWAY INTRODUCER
PBN HYSTERO-SALPINGOGRAPHY CATHETER SET
RF INTRODUCTION CANNULA
SPIROL BLOCK (19 GA. OPEN END MODELS), (20 GA. OPEN END MODELS), (19 GA. CLOSED END MODELS), (20 GA. CLOSED END MODELS)
Injector, vertebroplasty (does not contain cement)
MORGANSTERN PROSTATE STABILIZATION AND SEEDING KIT
BLADE, SCALPEL
OPTICAL INTEGRITY LASERGUARD FIBERS
ARTERIAL LINE KIT
MANAN BONE MARROW HARVEST NEEDLES
CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124
GUIDE, NEEDLE, SURGICAL
IV SET WITH GRADUATED CHAMBER
ACCESSORIES, CATHETER
Tissue culture tube
iTClamp50
IMC SURGICAL DRAPES
USCI IDEAL PTCA KIT
Burn sheet
Vacuum collection bottle
RACZ EPIDURAL CATHETER
Probe, lachrymal
HAWKINS BREAST LOCALIZATION NEEDLE
Dressing, wound, hydrogel without drug and/or biologic
QUINCKE SPINAL NEEDLE
MANAN TECHNA-CUT ASPIRATION NEEDLE
URESIL BILLIARY CATHETER
Elastic bandage
I.V. SET-LUER LOCK WITH LATEX FREE INJECTION SITE, MODEL B411
MANAN PRO-MAG AUTOMATIC BIOPSY SYSTEM
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)