6 results · 57ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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