Device Recall Pentax Rigid Laryngostroboscopes

  • Modelo / Serial
    Model #'s 9106 and 9108
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-US (nationwide) and countries of: Albania, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Croatia, Denmark, Ecuador, Egypt, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Oman, Philippines, Portugal, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Trinidad, Turkey, United Arab Emirates, and United Kingdom.
  • Descripción del producto
    Rigid Laryngostroboscopes || The Rigid Laryngostroboscopes, Models 9106 and 9108 are intended to observe glottic action with the use of a stroboscopic light source. The instrument is inserted per-orally when indications consistent with the need for observation are observed.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Pentax of America Inc, 3 Paragon Dr, Montvale NJ 07645-1782
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA