4,476 results
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61ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COASTWIDE
FDA UDI
Staples, Inc.·00718103389167·
ETS FLEX ARTICNG LNR CUTR 45MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·February 20, 2009
CONTOUR CUTTER STAPLER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·November 5, 2014
ECHELON*FLEX60 ARTICULATING
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·December 18, 2012
DOUBLE LOADED KNOTLESS FIBERTAK, KNEE
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code MBI·March 28, 2024
LIGAMAX-5MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·November 15, 2010
ENDOWRIST
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·April 17, 2026
ENDOWRIST
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code GDW·July 5, 2023
SUREFORM
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code GDW·August 7, 2025
SUREFORM
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code GDW·December 6, 2024
SUREFORM
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code GDW·December 5, 2024
SUREFORM
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code GDW·January 5, 2024
SUREFORM
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code GDW·April 22, 2026
SUREFORM
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code GDW·February 18, 2025
SUREFORM
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·January 3, 2025
MicroCutter Xchange 30 Blue Curved Tip Cartridge. Model Number: FG-025321; The MicroCutter XCHANGE 30 Blue Cartridge and MicroCutter XCHANGE 30 Blue Curved Tip Cartridge contain 316L stainless steel staples. The cartridges are used with the MicroCutter XCHANGE 30 Stapler, which is a single patient device. When the MicroCutter XCHANGE 30 Stapler is loaded with a MicroCutter XCHANGE 30 Cartridge, two double rows of 316L stainless steel staples are delivered while simultaneously transecting tissue between the two, double staple rows. The MicroCutter XCHANGE 30 Stapler and MicroCutter XCHANGE 30 Cartridge are designed for introduction and use through a 5mm trocar cannula or larger. The staple line length is 30 mm long. The Stapler can be loaded, fired, and reloaded with the MicroCutter XCHANGE 30 Cartridge for up to the number deployments indicated on package label in a single surgical procedure. The Stapler can fire different sized staples, with the size of the staple indicated by the color of the MicroCutter XCHANGE Cartridges. Intended for use in multiple open or minimally invasive surgical procedures for the transaction, resection, and /or creation of anastomoses in small and large intestine as well as the transection of the appendix.
FDA Enforcement
Class II
·Terminated·Cardica, Inc.·December 30, 2015
SUREFORM
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code GDW·October 22, 2025
SUREFORM
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code GDW·October 15, 2022
SUREFORM
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code GDW·December 12, 2024
SUREFORM
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code GDW·August 4, 2023