5 results
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7ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Video Cystoscope models ECY-1570 and ECY-1570K
FDA Enforcement
Class II
·Terminated·Pentax of America Inc·February 21, 2018
Video Duodenoscope
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·June 8, 2016
EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·July 30, 2014
Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·January 24, 2024
Spectral CT. Computed tomography X-ray system.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 2, 2025