6 results
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57ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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PENTAX Medical Video Colonoscope- Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract Model: EC38-i20cL
FDA Recall
Open, Classified
·Pentax of America Inc·Product code PEA·January 29, 2025
PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract Model: EG29-i20c
FDA Recall
Open, Classified
·Pentax of America Inc·Product code PEA·January 29, 2025
Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic diagnosis, treatment, and video observation. Model: EPK-i8020c
FDA Recall
Open, Classified
·Pentax of America Inc·Product code PEA·January 29, 2025
Pentax Medical Video Processor; Model Number: EPK-i8020c;
FDA Recall
Open, Classified
·Pentax of America Inc·Product code PEA·July 16, 2025
Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-2790i, EG-1690K, EG-2490K, EG-2790K, EG27-i10; Gastroscope Family # 2- Gastroscopes with a Water Jet Channel Models: EG-2990i, EG-2990K, EG-3490K, EG29-i10; Gastroscope Family # 3-Gastroscopes with Two Instrument Channels and a Water Jet Channel Models: EG-3890TK
FDA Recall
Open, Classified
·Pentax of America Inc·Product code FDF·July 14, 2021
Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet Channel Models: EC-2990Li, EC-3490Li, EC-3890Li, EC-3490TLi, EC-3490LK, EC-3890LK, EC3890LZi, EC34-i10L, EC38-i10L; Colonoscope Family # 2-Pentax Video Colonoscopes with Two Instrument Channels and a Water Jet Channel Model: EC-3890TLK
FDA Recall
Open, Classified
·Pentax of America Inc·Product code FDF·July 14, 2021