9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
×
Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures.
FDA Enforcement
Class II
·Terminated·OriGen Biomedical, Inc.·October 24, 2018
Reinforced Dual Lumen Cannula, 19Fr., REF: VV19F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures.
FDA Enforcement
Class II
·Terminated·OriGen Biomedical, Inc.·October 24, 2018
Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO
FDA Enforcement
Class II
·Terminated·OriGen Biomedical, Inc.·October 24, 2018
Reinforced Dual Lumen Cannula, 23Fr., REF: VV23F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures.
FDA Enforcement
Class II
·Terminated·OriGen Biomedical, Inc.·October 24, 2018
ECMO Reinforced Dual Lumen Cannula, 28Fr., REF: VV28F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures.
FDA Enforcement
Class II
·Terminated·OriGen Biomedical, Inc.·October 24, 2018
Reinforced Dual Lumen Cannula, 32Fr., REF: VV32F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures.
FDA Enforcement
Class II
·Terminated·OriGen Biomedical, Inc.·October 24, 2018
Reinforced Dual Lumen Cannula, 16Fr., REF: VV16F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures.
FDA Enforcement
Class II
·Terminated·OriGen Biomedical, Inc.·October 24, 2018
3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile EO, Rx Only
FDA Enforcement
Class II
·Terminated·OriGen Biomedical, Inc.·November 11, 2020
Accessory Sets Syringes: 6ml syringe with a female luer with 15cm sealed SCD tubing, REF: RF-T15, and 60ml syringe on a female luer with 15cm sealed SCD tubing, REF: 15-RF60-T
FDA Enforcement
Class II
·Ongoing·OriGen Biomedical, Inc.·February 21, 2024