2,753 results
·
44ms
·
Sources: EU EUDAMED, US FDA
LINX REFLUX MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·TORAX MEDICAL, INC.·Product code LEI·October 14, 2016
LINX REFLUX MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·TORAX MEDICAL, INC.·Product code LEI·April 22, 2016
1.5T LINX, 17 BEADS
FDA Adverse Event
Malfunction
·TORAX MEDICAL, INC.·Product code LEI·December 19, 2022
LINX Reflux Management System, Implant Clasp, 13-17 Bead, 1.5T, Product Code LXMC-xx, sterile, Rx only. Labeled as: a. Product Code LXMC-13; b. Product Code LXMC-14; c. Product Code LXMC-15; d. Product Code LXMC-16; e. Product Code LXMC-17; Laparoscopic, fundic-sparing anti-reflux procedure indicated for patients diagnosed with Gastroesophageal Reflux Disease (GERD) as defined by abnormal pH testing, and who are seeking an alternative to continuous acid suppression therapy (i.e. proton pump inhibitors or equivalent) in the management of their GERD.
FDA Recall
Terminated
·Torax Medical, Inc.·Product code LEI·April 20, 2018
LINX Reflux Management System, Implant Clasp, 13-16 Bead, 1.5T, Product Code LXM-xx, sterile, Rx only. Labeled as: a. Product Code LXM-13; b. Product Code LXM-14; c. Product Code LXM-15; d. Product Code LXM-16; Laparoscopic, fundic-sparing anti-reflux procedure indicated for patients diagnosed with Gastroesophageal Reflux Disease (GERD) as defined by abnormal pH testing, and who are seeking an alternative to continuous acid suppression therapy (i.e. proton pump inhibitors or equivalent) in the management of their GERD.
FDA Recall
Terminated
·Torax Medical, Inc.·Product code LEI·April 20, 2018
UNK LINX MAGNETIC IMPLANT
FDA Adverse Event
Injury
·TORAX MEDICAL, INC.·Product code LEI·October 1, 2019
FENIX CONTINENCE RESTRORATION SYSTEM
FDA Adverse Event
Injury
·TORAX MEDICAL, INC.·Product code PMH·November 21, 2016
FENIX CONTINENCE RESTRORATION SYSTEM
FDA Adverse Event
Injury
·TORAX MEDICAL, INC.·Product code PMH·November 21, 2016
LINX REFLUX MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·TORAX MEDICAL, INC.·Product code LEI·October 7, 2016
LINX REFLUX MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·TORAX MEDICAL, INC.·Product code LEI·October 7, 2016
LINX REFLUX MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·TORAX MEDICAL, INC.·Product code LEI·November 2, 2016
FENIX CONTINENCE RESTRORATION SYSTEM
FDA Adverse Event
Injury
·TORAX MEDICAL, INC.·Product code PMH·November 22, 2016
LINX REFLUX MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·TORAX MEDICAL, INC.·Product code LEI·November 2, 2016
LINX REFLUX MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·TORAX MEDICAL, INC.·Product code LEI·October 21, 2016
LINX REFLUX MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·TORAX MEDICAL, INC.·Product code LEI·December 28, 2016
LINX REFLUX MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·TORAX MEDICAL INC.·Product code LEI·July 22, 2015
LINX REFLUX MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·TORAX MEDICAL, INC.·Product code LEI·July 22, 2015
LINX REFLUX MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·TORAX MEDICAL, INC.·Product code LEI·August 31, 2015
LINX REFLUX MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·TORAX MEDICAL, INC.·Product code LEI·September 28, 2015
LINX REFLUX MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·TORAX MEDICAL INC.·Product code LEI·May 28, 2014