10 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Dexcom G4 PLATINUM (Pediatric) Receiver with Share Receiver Part Number: MT22608 Receiver (mg/dL), Black (pediatrics); MT22608-PNK, Receiver (mg/dL), Pink (pediatrics); MT22608-BLU, Receiver (mg/dL), Blue (pediatrics). Intended to detect trends and track glucose patterns in persons with diabetes.
FDA Enforcement
Class I
·Terminated·Dexcom Inc·April 20, 2016
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
Video Cystoscope models ECY-1570 and ECY-1570K
FDA Recall
Terminated
·Pentax of America Inc·Product code FAJ·July 13, 2017
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
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