44 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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EchoTip¿ Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520
FDA Enforcement
Class II
·Ongoing·Cook Medical Incorporated·May 22, 2024
EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012
FDA Enforcement
Class II
·Ongoing·Cook Medical Incorporated·May 22, 2024
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