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Pentax Medical

Division of Hoya Corp.
www.pentaxmedical.com

Latest From Pentax Medical

US FDA Says Custom Ultrasonics Device May Be Used To Disinfect Certain Duodenoscopes

Custom Ultrasonics' System 83 Plus automated endoscope reprocessors may now be used to disinfect specific models of Olympus and Pentax duodenoscopes, FDA says.

Regulation Recalls

FDA Warning Letters For Olympus, Fujifilm, Pentax: Duodenoscope-Makers Fail To Meet Agency's Post-Market Surveillance Study Order

US FDA sent the letters to Olympus Corp., Fujifilm Medical Systems USA Inc. and Pentax Medical after the firms failed to meet obligations to conduct Sec. 522 post-market studies on their duodenoscopes, the use of which caused a number of antibiotic-resistant superbug infections in 2013 and 2014.

FDA Enforcement

New Duodenoscope Protocols Released

US FDA, CDC and medical groups joined forces to develop safer handling standards for the endoscope equipment, which has been tied to infection outbreaks.

Regulation Safety

Easier-To-Clean Duodenoscope Gets US FDA Clearance

The device from Pentax features a disposable distal cap, thus cutting the risk of infection transmission between patients. An earlier Pentax duodenoscope model was the subject of an infection-related safety alert in January.

Safety Approvals
See All

Company Information

  • Industry
  • Medical Devices
    • Diagnostic Imaging Equipment & Supplies
  • Therapeutic Areas
  • Gastrointestinal
  • Gynecological, Urological
  • Otolaryngology
  • Respiratory, Pulmonary
  • Alias(es)
  • Asahi Optical Co.
  • Pentax Medical Co.
  • Pentax Precision Instrument Corp.
  • Ownership
  • Private
  • Headquarters
  • Worldwide
    • North America
      • USA
  • Parent & Subsidiaries
  • Hoya Corp.
  • Senior Management
  • Gene Merante, VP, Fin.
    Victor Capo, VP, Operations
    Joe Dawson, VP, Sales & Mktg.
  • Contact Info
  • Pentax Medical
    Phone: (201) 571-2300
    3 Paragon Dr.
    Montvale, NJ 07645
    USA
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