108 results
·
43ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
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
LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code LX-xx, sterile, Rx only. Labeled as: a. Product Code LX-12; b. Product Code LX-13; c. Product Code LX-14; d. Product Code LX-15; e. Product Code LX-16; f. Product Code LX-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 Suture, 12-17 Bead, 0.7T, Product Code LS-xx, sterile, Rx only. Labeled as: a. Product Code LS-12; b. Product Code LS-13; c. Product Code LS-14; d. Product Code LS-15; e. Product Code LS-16; f. Product Code LS-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, 12-17 Bead, 0.7T, Product Code LXC-xx, sterile, Rx only. Labeled as: a. Product Code LXC-12; b. Product Code LXC-13; c. Product Code LXC-14; d. Product Code LXC-15; e. Product Code LXC-16; f. Product Code LXC-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 Enforcement
Class II
·Terminated·Torax Medical, Inc.·June 6, 2018
LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code LX-xx, sterile, Rx only. Labeled as: a. Product Code LX-12; b. Product Code LX-13; c. Product Code LX-14; d. Product Code LX-15; e. Product Code LX-16; f. Product Code LX-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 Enforcement
Class II
·Terminated·Torax Medical, Inc.·June 6, 2018
LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code LXC-xx, sterile, Rx only. Labeled as: a. Product Code LXC-12; b. Product Code LXC-13; c. Product Code LXC-14; d. Product Code LXC-15; e. Product Code LXC-16; f. Product Code LXC-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 Enforcement
Class II
·Terminated·Torax Medical, Inc.·June 6, 2018
LINX Reflux Management System, Implant Suture, 12-17 Bead, 0.7T, Product Code LS-xx, sterile, Rx only. Labeled as: a. Product Code LS-12; b. Product Code LS-13; c. Product Code LS-14; d. Product Code LS-15; e. Product Code LS-16; f. Product Code LS-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 Enforcement
Class II
·Terminated·Torax Medical, Inc.·June 6, 2018
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 Enforcement
Class II
·Terminated·Torax Medical, Inc.·June 6, 2018
Angiotech, T-Lok Bone Marrow Biopsy Needle, Medical Device Technologies, Inc. The device is intended for use during Bone Marrow Biopsy.
FDA Recall
Terminated
·Medical Device Technologies, Inc.·Product code KNW·July 16, 2008
Angiotech, Bone Marrow Aspiration Needle, Medical Device Technologies, Inc. Individual packaged in blister pack. Packaged 10 per box. Sterile.
FDA Recall
Terminated
·Medical Device Technologies, Inc.·Product code KNW·July 16, 2008
Angiotech, Bone Marrow Biopsy Needle, Medical Device Technologies, Inc. The device is intended for use during Bone Marrow Biopsy.
FDA Recall
Terminated
·Medical Device Technologies, Inc.·Product code KNW·July 16, 2008
Angiotech, Bone Marrow Harvest Needle, Medical Device Technologies, Inc. The device is intended for use Bone Marrow Biopsy.
FDA Recall
Terminated
·Medical Device Technologies, Inc.·Product code KNW·July 16, 2008
Smiths Medical ASD, Inc. Regional Anesthesia Trays containing the Hospira 2ml drug ampuls of 5% Lidocaine Hydrochloride with 7.5% Dextrose Injection, (NDC 0074-4712-01, lot number 09-568-DK) as follows: Product Number/Description 15248C-22/25 SPINAL TRAY 22/25 (SDD)W/DRUGS
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code CAZ·July 2, 2004
A2675-25 SPINAL(SHB)W/DRUGS
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code CAZ·July 2, 2004
A3077-25 SPINAL (SDD) W/DRUGS
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code CAZ·July 2, 2004
A2152-25 SPINAL(FL)WHITACRE W/DRUGS
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code CAZ·July 2, 2004
A2526-24 SPINAL (SHB) W/DRUGS
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code CAZ·July 2, 2004
A1645-25 SPINAL(FL)WHITACRE W/DRUGS
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code CAZ·July 2, 2004