42 results
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20ms
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Sources: EU EUDAMED, US FDA
Flexor RTPS Guiding Sheath Product Usage: The Flexor RTPS Guiding Sheaths are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices. These curved sheaths are manufactured from material incorporating a stainless steel wire imbedded in the sheath shaft material with a soft tip and a Check-Flo¿ fitting at the proximal end. The sheath is accompanied by a dilator for access to the body as a catheter over the wire guide.
FDA Enforcement
Class II
·Terminated·Cook Inc.·July 29, 2015
Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System
FDA Enforcement
Class II
·Terminated·Cook Medical Incorporated·February 3, 2016
Spirotome" Soft-Tissue Biopsy Needle Set. The Spirotome Biopsy Needle Set includes a two-part introducer needle that consists of a cutting cannula and a trocar stylet, a helical-tip biopsy needle that has been sized to fit through the lumen of the cutting cannula. The Spirotome Biopsy Needle Set is intended for percutaneous acquisition of soft tissue specimens for laboratory analysis.
FDA Enforcement
Class II
·Terminated·Cook Medical Incorporated·November 5, 2014
Zilver 518 Biliary Stent 5mm x 30mm, Catalog Number: ZIB5-125-5.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
FDA Enforcement
Class II
·Terminated·Cook Medical Incorporated·November 7, 2018
Zilver 635 Biliary Stent 5mm x 30mm, Catalog Number: ZIB6-80-5.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
FDA Enforcement
Class II
·Terminated·Cook Medical Incorporated·November 7, 2018
Zilver 635 Biliary Stent 14mm x 80mm, Catalog Number: ZIB6-125-14.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
FDA Enforcement
Class II
·Terminated·Cook Medical Incorporated·November 7, 2018
Zilver 635 Biliary Stent 5mm x 20mm, Catalog Number: ZIB6-125-5.0-20 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
FDA Enforcement
Class II
·Terminated·Cook Medical Incorporated·November 7, 2018
Zilver 635 Biliary Stent 12mm x 80mm, Catalog Number: ZIB6-125-12.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
FDA Enforcement
Class II
·Terminated·Cook Medical Incorporated·November 7, 2018
Zilver 635 Biliary Stent 5mm x 40mm, Catalog Number: ZIB6-125-5.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
FDA Enforcement
Class II
·Terminated·Cook Medical Incorporated·November 7, 2018
Zilver 635 Biliary Stent 14mm x 30mm, Catalog Number: ZIB6-80-14.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
FDA Enforcement
Class II
·Terminated·Cook Medical Incorporated·November 7, 2018
Zilver 635 Biliary Stent 12mm x 60mm, Catalog Number: ZIB6-80-12.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
FDA Enforcement
Class II
·Terminated·Cook Medical Incorporated·November 7, 2018
Zilver 518 Biliary Stent 5mm x 80mm, Catalog Number: ZIB5-125-5.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
FDA Enforcement
Class II
·Terminated·Cook Medical Incorporated·November 7, 2018
Zilver 635 Biliary Stent 12mm x 80mm, Catalog Number: ZIB6-80-12.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
FDA Enforcement
Class II
·Terminated·Cook Medical Incorporated·November 7, 2018
Zilver 635 Biliary Stent 12mm x 30mm, Catalog Number: ZIB6-80-12.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
FDA Enforcement
Class II
·Terminated·Cook Medical Incorporated·November 7, 2018
Zilver 635 Biliary Stent 5mm x 40mm, Catalog Number: ZIB6-80-5.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
FDA Enforcement
Class II
·Terminated·Cook Medical Incorporated·November 7, 2018
Zilver 518 Biliary Stent 4mm x 20mm, Catalog Number: ZIB5-125-4.0-20 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
FDA Enforcement
Class II
·Terminated·Cook Medical Incorporated·November 7, 2018
Zilver 635 Biliary Stent 5mm x 80mm, Catalog Number: ZIB6-125-5.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
FDA Enforcement
Class II
·Terminated·Cook Medical Incorporated·November 7, 2018
Zilver 635 Biliary Stent 5mm x 30mm, Catalog Number: ZIB6-125-5.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
FDA Enforcement
Class II
·Terminated·Cook Medical Incorporated·November 7, 2018
Zilver 635 Biliary Stent 12mm x 30mm, Catalog Number: ZIB6-125-12.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
FDA Enforcement
Class II
·Terminated·Cook Medical Incorporated·November 7, 2018
Zilver 635 Biliary Stent 14mm x 60mm, Catalog Number: ZIB6-80-14.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
FDA Enforcement
Class II
·Terminated·Cook Medical Incorporated·November 7, 2018