3 results
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6ms
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Sources: EU EUDAMED, US FDA
PENTAX Endoscopic Accessories. OF-B194. Made in Japan. PENTAX Upper/Lower G.I. Endoscopes are provided with Air/Water Valve. As an alternative, the optionally available Gas/Water Valve may be used in place of the standard Air/Water Valve to deliver a non-explosive gas for insufflation.
FDA Enforcement
Class I
·Terminated·Pentax Medical Company·November 6, 2013
Regard Dressing change kit, Item Number 800026006
FDA Enforcement
Class I
·Terminated·ROi CPS LLC·January 10, 2024
regard Operative LAP, Item Number 800943001; surgical convenience kit
FDA Enforcement
Class I
·Terminated·ROi CPS LLC·January 24, 2024