18 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Pentax Video Colonoscope Model: EC34-i10L
FDA Recall
Terminated
·Pentax of America Inc·Product code FDF·January 3, 2020
Pentax Video Colonoscope Model: EC38-i10L
FDA Recall
Terminated
·Pentax of America Inc·Product code FDF·January 3, 2020
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 Recall
Terminated
·Pentax Medical Company·Product code FDS·June 12, 2014
Video Cystoscope models ECY-1570 and ECY-1570K
FDA Recall
Terminated
·Pentax of America Inc·Product code FAJ·July 13, 2017
PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve
FDA Recall
Terminated
·Pentax Medical Company·Product code KOG·July 17, 2014
Gastroscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
FDA Recall
Terminated
·Pentax Medical Company·Product code FDF·April 6, 2016
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.
FDA Recall
Terminated
·Pentax of America Inc·Product code EQL·December 12, 2016
Signmoidoscope Product Usage: Intended to provide optical visualization of, therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Large Bowel to the Sigmoid Colon. The instrument is introduced via the rectum when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
FDA Recall
Terminated
·Pentax Medical Company·Product code FAM·April 6, 2016
Ultrasound Gastroscope Product Usage: Intended to provide optical visualization of, ultrasonic Visualization of, and therapeutic access to the Upper Gastrointestinal Tract including but not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Small Bowel and underlying areas. The instrument is introduced via per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.
FDA Recall
Terminated
·Pentax Medical Company·Product code ODG·April 6, 2016
Colonoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Large Bowel to the Cecum. The instrument is introduced via the rectum when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
FDA Recall
Terminated
·Pentax Medical Company·Product code FDF·April 6, 2016
Confocal GI Scope Product Usage: Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, and Large Bowel to the Cecum. The instrument is introduced via the mouth or rectum as decided by the the anatomy being accessed when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
FDA Recall
Terminated
·Pentax Medical Company·Product code GCJ·April 6, 2016
Duodenoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, and Large Bowel to the Cecum. The instrument is introduced via the mouth or rectum as decided by the the anatomy being accessed when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
FDA Recall
Terminated
·Pentax Medical Company·Product code FDT·April 6, 2016
Video Duodenoscope These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the biliary tract via the upper GI tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: esophagus, stomach, duodenum, common bile, hepatic and cystic ducts.
FDA Recall
Terminated
·Pentax of America Inc·Product code FDT·January 17, 2017
C2 CryoBalloon Controller, REF: FG-1017, with Controller Software v1.18.258 The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of general surgery, specifically for endoscopic application and the ablation of dysplastic Barrett s Esophagus.
FDA Recall
Terminated
·PENTAX of America Inc·Product code GEH·December 3, 2018
Pentax Medical Video Duodenoscope - Product Usage: intended to be used with endoscopic devices and other ancillary equipment to provide optical visualization of (via a video monitor), and therapeutic access to, Biliary Tract via the Upper Gastrointestinal Tract, Model Number: ED34-i10T2.
FDA Recall
Terminated
·Pentax of America Inc·Product code FDT·April 21, 2021
9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal),
FDA Recall
Terminated
·Pentax of America Inc·Product code OUG·September 22, 2020
9310HD Digital Video Capture Module with software version 3.4.0 or higher configured with 9263 endoPortal
FDA Recall
Terminated
·Pentax of America Inc·Product code OUG·September 22, 2020
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012