222 results
·
51ms
·
Sources: EU EUDAMED, US FDA
EsophyX2 HD
FDA UDI
ENDOGASTRIC SOLUTIONS, INC.·00810275011065·EsophyX®2 HD Device with SerosaFuse Fasteners a...
7.5mm Cartridge
FDA UDI
ENDOGASTRIC SOLUTIONS, INC.·00810275013021·Cartridge, 20 Fasteners, 0.010" Slot, 7.5mm Web
EsophyX Z+
FDA UDI
ENDOGASTRIC SOLUTIONS, INC.·00810275011089·EsophyX Z+ Fastener Delivery Device with Serosa...
6.5mm & 7.5mm Cartridge
FDA UDI
ENDOGASTRIC SOLUTIONS, INC.·00810275013038·Cartridge, 40 Implantable Fasteners, 6.5mm & 7....
SerosaFuse® Implantable Fastener Kit
FDA UDI
ENDOGASTRIC SOLUTIONS, INC.·00810275014011·Single kit consists of 1 each R2007 EsophyX Z+ ...
SerosaFuse® 7.5mm Implantable Fastener Cartridges
FDA UDI
ENDOGASTRIC SOLUTIONS, INC.·00810275013052·2 Cartridges, 40 Implantable Fasteners, 7.5mm ...
6.5mm Cartridge
FDA UDI
ENDOGASTRIC SOLUTIONS, INC.·00810275013014·Cartridge, 20 Fasteners, 0.010" Slot, 6.5mm Web
EsophyX Z
FDA UDI
ENDOGASTRIC SOLUTIONS, INC.·00810275011072·EsophyX Z Fastener Delivery Device with SerosaF...
ESOPHYX Z+
FDA Adverse Event
Malfunction
·ENDOGASTRIC SOLUTIONS, INC.·Product code ODE·December 9, 2020
ESOPHYX Z+ OR SEROSAFUSE IMPLANTABLE FASTENER
FDA Adverse Event
Injury
·ENDOGASTRIC SOLUTIONS, INC·Product code ODE·August 10, 2023
ESOPHYX Z+ OR SEROSAFUSE IMPLANTABLE FASTENER
FDA Adverse Event
Injury
·ENDOGASTRIC SOLUTIONS, INC·Product code ODE·August 11, 2023
ESOPHYX Z+ OR SEROSAFUSE IMPLANTABLE FASTENER
FDA Adverse Event
Injury
·ENDOGASTRIC SOLUTIONS, INC·Product code ODE·August 10, 2023
ESOPHYX Z+ OR SEROSAFUSE IMPLANTABLE FASTENER
FDA Adverse Event
Injury
·ENDOGASTRIC SOLUTIONS, INC·Product code ODE·August 10, 2023
ESOPHYX Z+ OR SEROSAFUSE IMPLANTABLE FASTENER
FDA Adverse Event
Injury
·ENDOGASTRIC SOLUTIONS, INC·Product code ODE·August 10, 2023
EndoGastric Solutions EsophyX2 Device with Serosa Fastener and Accessories. Models R2001 and R2002. Indicated for the treatment of symptomatic chronic gastroesophageal reflux disease.
FDA Enforcement
Class II
·Terminated·Endogastric Solutions Inc·August 28, 2013
EndoGastric Solutions EsophyX2 Device with Serosa Fastener and Accessories. Models R2001 and R2002. Indicated for the treatment of symptomatic chronic gastroesophageal reflux disease.
FDA Recall
Terminated
·Endogastric Solutions Inc·Product code ODE·June 6, 2013
EndoGastric Solutions EsophyX2 Plus Device with Serosa Fastener and Accessories Part number C02033-01. Label reads in part "EsophyX2 2-LINK Device Qty: (1) Fastener Delivery System ***" Designed for the treatment of Gastroesophageal Reflux Disease (GERD), with erosive and non-erosive esophagitis
FDA Recall
Terminated
·Endogastric Solutions Inc·Product code ODE·February 4, 2013
ESOPHYX Z+
FDA Adverse Event
Injury
·ENDOGASTRIC SOLUTIONS, INC·Product code ODE·February 26, 2024
ESOPHYX2 - LINK DESIGN - SHORT
FDA Adverse Event
Injury
·ENDOGASTRIC SOLUTIONS, INC·Product code ODE·February 28, 2012
ESOPHYX2 -05
FDA Adverse Event
Injury
·ENDOGASTRIC SOLUTIONS, INC·Product code ODE·February 29, 2012