120 results · 21ms · Sources: EU EUDAMED, US FDA

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UltraxxTM Nephrostomy Balloon Set The Ultraxx" Nephrostomy Balloon Set consists of a radiopaque balloon catheter, radiopaque sheath, and inflation device. The Ultraxx" Nephrostomy Balloon Set is used to dilate the musculofascia, renal capsule, and parenchyma to establish and maintain a percutaneous tract.

FDA Recall
Terminated ·Cook Inc.·Product code LJE·January 27, 2016

Ascend AQ Ureteral Dilation Balloon Catheter Set The Ascend AQ Ureteral Dilation Balloon Catheter Set consists of a radiopaque balloon catheter and inflation device. The Ascend AQ Ureteral Dilation Balloon Catheter Set is used for transluminal dilation of ureteral strictures or ureteral dilation prior to ureteroscopy and stone manipulation.

FDA Recall
Terminated ·Cook Inc.·Product code LJE·January 27, 2016

Kopans Breast Lesion Localization Needle The Kopans Breast Lesion Localization Needle consists of a bevel-tip needle with centimeter markings and a hookwire. The hookwire features a burnish mark that allows the operator to ensure that the hookwire is within the needle tip during needle manipulation. The Kopans Breast Lesion Localization Needle is intended for preoperative marking of nonpalpable breast lesions.

FDA Recall
Terminated ·Cook Inc.·Product code MIJ·January 8, 2016

Cook Spectrum Minocycline/Rifampin Impregnated Double Lumen Central Venous Catheter Tray Cook Spectrum Minocycline/Rifampin Impregnated Triple Lumen Central Venous Catheter Tray

FDA Recall
Terminated ·Cook Inc.·Product code FOZ·November 28, 2016

Percutaneous Gastrojejunostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding

FDA Recall
Terminated ·Cook Inc.·Product code KNT·October 19, 2017

Wills-Oglesby Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding

FDA Recall
Terminated ·Cook Inc.·Product code KNT·October 19, 2017

Mallinckrodt Institute Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding

FDA Recall
Terminated ·Cook Inc.·Product code KNT·October 19, 2017

Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-20-56-ZT, REF G48469, 16Fr ID/ 6.0 mm OD, Sterile.

FDA Recall
Terminated ·Cook, Inc.·Product code MIH·April 15, 2011

Cook Medical Zenith Flex AAA Main Body Extension, REF ESBE-30-39, REF G32183, 20 Fr. ID/ 7.7 OD, Sterile.

FDA Recall
Terminated ·Cook, Inc.·Product code MIH·April 15, 2011

Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-16-56-ZT, REF G48461, 16Fr ID/ 6.0 mm OD, Sterile.

FDA Recall
Terminated ·Cook, Inc.·Product code MIH·April 15, 2011

Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-20-90-ZT, REF G48471, 16Fr ID/ 6.0 mm OD, Sterile.

FDA Recall
Terminated ·Cook, Inc.·Product code MIH·April 15, 2011

Cook Medical Zenith Flex AAA Main Body Extension, REF ESBE-22-29, REF G32179, 18 Fr. ID/ 6.90 OD, Sterile.

FDA Recall
Terminated ·Cook, Inc.·Product code MIH·April 15, 2011

Cook Medical Zenith Flex AAA Main Body Extension, REF ESBE-32-39, REF G32184, 20 Fr. ID/ 7.7 mm OD, Sterile.

FDA Recall
Terminated ·Cook, Inc.·Product code MIH·April 15, 2011

Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-16-90-ZT, REF G48463, 16Fr ID/ 6.0 mm OD, Sterile.

FDA Recall
Terminated ·Cook, Inc.·Product code MIH·April 15, 2011

Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-12-56-ZT, REF G48449, 16Fr ID/ 6.0 mm OD, Sterile.

FDA Recall
Terminated ·Cook, Inc.·Product code MIH·April 15, 2011

Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-24-73-ZT, REF G48478, 16Fr ID/ 6.0 mm OD, Sterile.

FDA Recall
Terminated ·Cook, Inc.·Product code MIH·April 15, 2011

Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-20-56-ZT, REF G48473, 16Fr ID/ 6.0 mm OD, Sterile.

FDA Recall
Terminated ·Cook, Inc.·Product code MIH·April 15, 2011

Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-20-73-ZT, REF G48470, 16Fr ID/ 6.0 mm OD, Sterile.

FDA Recall
Terminated ·Cook, Inc.·Product code MIH·April 15, 2011

Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-18-56-ZT, REF G48465, 16Fr ID/ 6.0 mm OD, Sterile.

FDA Recall
Terminated ·Cook, Inc.·Product code MIH·April 15, 2011

Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-16-73-ZT, REF G48462, 16Fr ID/ 6.0 mm OD, Sterile.

FDA Recall
Terminated ·Cook, Inc.·Product code MIH·April 15, 2011