8 results
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15ms
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Sources: EU EUDAMED, US FDA
Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW; Reference Part Numbers: CMW-14-190-12G CMW-14-190-18G CMW-14-190-25G CMW-14-190-6G CMW-14-300-12G CMW-14-300-18G CMW-14-300-25G CMW-14-300-6G
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·November 20, 2024
COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G, Order Number G50787; Reference Part Number CMW-14-300-12G, Order Number G50791
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·April 15, 2026
COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G, Order Number G50788; Reference Part Number CMW-14-300-18G, Order Number G50792
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·April 15, 2026
Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·November 27, 2024
COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G50786
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·April 15, 2026
Medline Convenience kits used for various procedures: 1) CW PERI GYN, Model Number: DYNJ80807B
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 23, 2025
NautilusTM Smart ECMO Module with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Product Number: 48135, 48135E
FDA Enforcement
Class II
·Ongoing·Mc3 Inc·March 27, 2024
NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Product Number: (1) 48145; (2) 48145E
FDA Enforcement
Class II
·Ongoing·Mc3 Inc·March 27, 2024