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Sources: EU EUDAMED, US FDA
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ev3 Inc. 4600 Nathan Lane, Plymouth, MN Protg " GPS" Self-Expanding Biliary Stent System, Sterile EO, 14 mm 60mm 80 cm, REF SERB65-14-60-80, Rx only. ev3 Inc. 4600 Nathan Lane, Plymouth, MN Protg " GPS" Self-Expanding Biliary Stent System, Sterile EO, 12 mm 60mm 80 cm, REF SERB65-12-60-80, Rx only.
FDA Recall
Terminated
·Product code FGE·October 30, 2010
ev3 The Endovascular Company, Protege GPS 8mm x 40mm Self Expanding Biliary Stent System, Rx Only, and SERB65-08-40-120. In the US, the intended as a palliative treatment of malignant neoplasms in the biliary tree. Outside the US, the intended for use in occlusions, lesions at high risk for abrupt closure or threatened closure following percutaneous transluminal angioplasty (PTA) or lesions believed to be at high risk for restenosis following PTA in the common and external iliac, subclavian or renal arteries.
FDA Recall
Terminated
·Product code FGE·June 10, 2009
ev3 The Endovascular Company, Protege GPS 6mm x 80mm Self Expanding Biliary Stent System, Rx Only, and SERB65-06-80-120. In the US, the intended as a palliative treatment of malignant neoplasms in the biliary tree. Outside the US, the intended for use in occlusions, lesions at high risk for abrupt closure or threatened closure following percutaneous transluminal angioplasty (PTA) or lesions believed to be at high risk for restenosis following PTA in the common and external iliac, subclavian or renal arteries.
FDA Recall
Terminated
·Product code FGE·June 10, 2009
ev3 The Endovascular Company, Protege GPS 6mm x 80mm Self Expanding Peripheral Stent System , Rx Only, and SERP65-06-80-120. In the US, the intended as a palliative treatment of malignant neoplasms in the biliary tree. Outside the US, the intended for use in occlusions, lesions at high risk for abrupt closure or threatened closure following percutaneous transluminal angioplasty (PTA) or lesions believed to be at high risk for restenosis following PTA in the common and external iliac, subclavian or renal arteries.
FDA Recall
Terminated
·Product code FGE·June 10, 2009
ev3 The Endovascular Company, Protege GPS 8mm x 40mm Self Expanding Peripheral Stent System , Rx Only, and SERP65-08-40-120. In the US, the intended as a palliative treatment of malignant neoplasms in the biliary tree. Outside the US, the intended for use in occlusions, lesions at high risk for abrupt closure or threatened closure following percutaneous transluminal angioplasty (PTA) or lesions believed to be at high risk for restenosis following PTA in the common and external iliac, subclavian or renal arteries.
FDA Recall
Terminated
·Product code FGE·June 10, 2009
ev3 Protege GPS Self-Expanding Nitinol Stent Biliary System. SERB65-09-60-120.
FDA Recall
Terminated
·Product code FGE·December 6, 2006
Ev3 Primus GPS Biliary Stent System 8 mm, 37 mm, B7, .40 mm, 5Fr, REF BXB35-08-37-75 Use before 2009-02 Sterile EO Ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 Intended as a palliative treatment of malignant neoplasms in the biliary tree.
FDA Recall
Terminated
·Product code FGE·April 22, 2008
ev3 Protege GPS Self-Expanding Nitinol Stent Biliary System--- Sterilization with Ethylene Oxide Gas. ev3, 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA. The self-expanding stent is made of nickel titanium alloy (Nitinol) and comes pre-mounted on an over-the-wire delivery system. The stent is cut from a nitinol tube into an open lattice design and is designed with tantalum radiopaque markers at the proximal and distal ends of the stent. Upon deployment, the stent achieves its predetermined diameter and exerts a constant, gentle outward force to establish patency in the biliary ducts.
FDA Recall
Terminated
·Product code FGE·February 27, 2006
Instructions For Use document of the GPS Trackers.
FDA Recall
Terminated
·Product code OLO·September 10, 2020
Exactech Shoulder GPS Impactor Handle, Catalog #531-07-05.
FDA Recall
Open, Classified
·Exactech, Inc.·Product code OLO·June 5, 2023
Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool
FDA Recall
Terminated
·Exactech, Inc.·Product code OLO·July 11, 2017
Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
FDA Recall
Completed
·Medtronic Inc.·Product code NIP·November 20, 2023
Protege GPS Biliary System (6Fr 10mm x 30mm) - Product number SER6-10-30-135 (.018) (Biliary)
FDA Recall
Terminated
·Product code FGE·July 9, 2004
Protege GPS Biliary System (6Fr 10mm x 30mm) - Product number SERB65-10-30-120 (.035) (Biliary)
FDA Recall
Terminated
·Product code FGE·July 9, 2004
ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 5mm x 14mm 80 cm .018" REF PMB 8-5-14-80
FDA Recall
Terminated
·Product code FGE·January 29, 2004
ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 6mm x 14mm 80 cm .018" REF PMB 8-6-14-80
FDA Recall
Terminated
·Product code FGE·January 29, 2004
ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System 5mm x 21mm 80 cm .014" REF PMB 4-5-21-80
FDA Recall
Terminated
·Product code FGE·January 29, 2004
ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System 5mm x 18mm 80 cm .014" REF PMB 4-5-18-80
FDA Recall
Terminated
·Product code FGE·January 29, 2004
ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 6mm x 21mm 80 cm .018" REF PMB 8-6-21-80
FDA Recall
Terminated
·Product code FGE·January 29, 2004
ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 7mm x 18mm 80 cm .018" REF PMB 8-7-18-80
FDA Recall
Terminated
·Product code FGE·January 29, 2004