BEUDAMED
    25 results · 11ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-150 ORDER NUMBER (GPN):G56161. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

    FDA Enforcement
    Class II ·Ongoing·Cook Incorporated·September 21, 2022

    Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-150 ORDER NUMBER (GPN): G56152. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

    FDA Enforcement
    Class II ·Ongoing·Cook Incorporated·September 21, 2022

    Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-80 ORDER NUMBER (GPN): G56172. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

    FDA Enforcement
    Class II ·Ongoing·Cook Incorporated·September 21, 2022

    Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-80 ORDER NUMBER (GPN): G56151. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

    FDA Enforcement
    Class II ·Ongoing·Cook Incorporated·September 21, 2022

    Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-80 ORDER NUMBER (GPN): G56162. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

    FDA Enforcement
    Class II ·Ongoing·Cook Incorporated·September 21, 2022

    MINOR CATH LAB PACK DYNJ84775A OR VASCULAR ANGIO PACK DYNJ47269D PORT-A-CATH DYNJ63276G

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·June 24, 2026

    Trocar Needle - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal system REFERENCE PART NUMBER (RPN): DTN-18-20.0 ORDER NUMBER (GPN): G01377

    FDA Enforcement
    Class II ·Ongoing·Cook Incorporated·April 24, 2024

    Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN)RFPC-35-180 ORDER NUMBER (GPN) G07937. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

    FDA Enforcement
    Class II ·Ongoing·Cook Incorporated·September 21, 2022

    Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPW-35-150 ORDER NUMBER (GPN):G56149. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

    FDA Enforcement
    Class II ·Ongoing·Cook Incorporated·September 21, 2022

    Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-80 ORDER NUMBER (GPN): G56175. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

    FDA Enforcement
    Class II ·Ongoing·Cook Incorporated·September 21, 2022

    Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN):RLPC-35-180 ORDER NUMBER (GPN) G07516. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

    FDA Enforcement
    Class II ·Ongoing·Cook Incorporated·September 21, 2022

    Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RPC-35-180 ORDER NUMBER (GPN):G07518. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

    FDA Enforcement
    Class II ·Ongoing·Cook Incorporated·September 21, 2022

    Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-150 ORDER NUMBER (GPN): G56176. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

    FDA Enforcement
    Class II ·Ongoing·Cook Incorporated·September 21, 2022

    Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RFSPC-35-180 ORDER NUMBER (GPN) G09608. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

    FDA Enforcement
    Class II ·Ongoing·Cook Incorporated·September 21, 2022

    Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures.

    FDA Enforcement
    Class II ·Ongoing·Stryker Instruments·August 3, 2022

    Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-150 ORDER NUMBER (GPN): G56173. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

    FDA Enforcement
    Class II ·Ongoing·Cook Incorporated·September 21, 2022

    Dilator With AQ Hydrophilic Coating - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems. REFERENCE PART NUMBER (RPN)/ORDER NUMBER (GPN): 1) JCD10.0-38-20-HC G10207 2) JCD14.0-38-20-HC G10293 3) JCD16.0-38-20-HC G10206 4) JCD6.0-38-20-HC G10285 5) JCD8.0-38-20-HC G10289

    FDA Enforcement
    Class II ·Ongoing·Cook Incorporated·April 24, 2024

    Dilator - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems. 1) JCD10.0-38-20 2) JCD20.0-38-20 3) JCD22.0-38-20 4) JCD6.0-38-15 5) JCD8.0-38-15 6) JCD8.0-38-20

    FDA Enforcement
    Class II ·Ongoing·Cook Incorporated·April 24, 2024

    FLOW COUPLER Monitor Flow Coupler devices are sold in 5 sizes (2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm). Implantable device for vascular use.

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·February 10, 2021

    Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems. REFERENCE PART NUMBER (RPN)/ORDER NUMBER (GPN): 1) JCD10.0-38-20- COONS G03928 2) JCD12.0-38-20- COONS G03929 3) JCD14.0-38-20- COONS G03932 4) JCD16.0-38-20- COONS G03947 5) JCD18.0-38-20- COONS G04051 6) JCD20.0-38-20- COONS G04264 7) JCD22.0-38-20- COONS G04443 8) JCD6.0-38-20- COONS G04221 9) JCD8.0-38-20- COONS G03927

    FDA Enforcement
    Class II ·Ongoing·Cook Incorporated·April 24, 2024