19 results
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Sources: EU EUDAMED, US FDA
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ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV28F
FDA Enforcement
Class I
·Terminated·OriGen Biomedical, Inc.·June 12, 2019
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV16F
FDA Enforcement
Class I
·Terminated·OriGen Biomedical, Inc.·June 12, 2019
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV23F
FDA Enforcement
Class I
·Terminated·OriGen Biomedical, Inc.·June 12, 2019
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV32F
FDA Enforcement
Class I
·Terminated·OriGen Biomedical, Inc.·June 12, 2019
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV19F
FDA Enforcement
Class I
·Terminated·OriGen Biomedical, Inc.·June 12, 2019
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV13F
FDA Enforcement
Class I
·Terminated·OriGen Biomedical, Inc.·June 12, 2019
OriGen BIOMEDICAL VV13F Reinforced Dual Lumen Catheter STERILE DISPOSABLE: DO NOT RE-USE Manufactured by: OriGen Biomedical. OriGene VV13F Reinforced Dual Lumen Catheter 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 of six hours or less.
FDA Enforcement
Class I
·Terminated·OriGen Biomedical, Inc.·April 29, 2015
REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NOT RE-USE CE 0473 Product Usage: The OriGen RDLC catheter is indicated for use as a single cannula for both venous drainage and arterial re-infusion of blood in the internal jugular vein during extracorporeal life support procedures of six hours or less.
FDA Enforcement
Class I
·Terminated·OriGen Biomedical, Inc.·November 14, 2018
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
The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position.
FDA Enforcement
Class I
·Terminated·OriGen Biomedical, Inc.·November 1, 2017
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
Evolve Cell Culture Bags, part numbers: EV1000N and EV3000N The Evolve bag is made of Ethyl Vinyl Olefin (EVO) and contains no BPA or latex. The bag can be supplied with tubing sets that can include, but are not limited to, the following components: EVA/PVC coextruded tubing, PVC tubing, Yconnectors, needle-free valves, female luers, male luers and/or caps
FDA Enforcement
Class III
·Terminated·OriGen Biomedical, Inc.·April 21, 2021
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