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Regulatory & Quality

Quality is our priority! We are making healthcare better by providing timely and accurate medical devices and services which meet regulatory requirements through an effective quality system and a safe work environment.

All medical devices manufactured by Argon Medical Devices, Inc. have been designed, developed and manufactured using standards specified by ISO 13485:2003 and the U.S. Food and Drug Administration.

If you’d like to share information with us about your product experience, please

 

  • Athens TX Full Quality Assurance Certificate
  • Athens TX Production Quality Certificate
  • Atrieve Vascular Snare Kit CE Certificate
  • First PICC Catheter DE Certificate
  • Full Quality Assurance System CE 565719 Directive 93-42-EEC
  • Guidewires DE Certificate
  • Jawz Endomyocardial Biopsy Forceps DE Certificate
  • L-Cath Peripherally Inserted Central Catheters DE Certificate
  • OptionELITE Vena Cava Filter System CE Certificate
  • UltraStream Chronic Dialysis Catheter Kit CE Certificate
  • Worker Guidewires CE Certificate
  • Athens TX Korean cGMP Certificate
  • Athens TX 13485 Certificate
  • Henrietta NY 13485 Certificate
  • Wheeling IL 13485 Certificate
  • Japanese Registration Certificate