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

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    GALT Guidewire REF SGW-051-07 Guidewires are intended for use in percutaneous procedures, to introduce and position catheters and other interventional devices within the Coronary and peripheral vasculature.

    FDA Recall
    Open, Classified ·Galt Medical Corporation·Product code DQX·March 27, 2025

    B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model Number: BCL-100-04 The Elite HV Introducer System is indicated for use in percutaneous procedures to introduce catheters and other intravascular devices into the vasculature.

    FDA Recall
    Open, Classified ·Galt Medical Corporation·Product code DYB·March 27, 2025

    Introducer Needle REF NDL-107-04 These needles are used for the percutaneous introduction of guidewires

    FDA Recall
    Open, Classified ·Galt Medical Corporation·Product code DWS·March 27, 2025

    GALT Centeze Catheter REF: DRC-002-05 DRC-002-06 The Centeze is intended for use in percutaneous fluid aspirations and small volume drainage procedures. For both adult and adolescent groups.

    FDA Recall
    Open, Classified ·Galt Medical Corporation·Product code KGZ·March 27, 2025

    B Braun Interventional Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-018-41, KIT-019-37 These Micro-Introducer Kits are intended to introduce up to a .038 inch guidewire or catheter into the vascular system following a small gauge needle stick.

    FDA Recall
    Open, Classified ·Galt Medical Corporation·Product code DRE·March 27, 2025

    Introducer Kit- Coaxial Dilator REF: KIT-002-28, 00841268104730 KIT-002-34, 00841268104792 KIT-002-35, 00841268104808 KIT-011-40, 00841268105553 KIT-011-62, 00841268105614 KIT-038-04, 00841268104556 KIT-039-03, 00841268104587 KIT-039-13, 00841268106055 KIT-081-02 / PS2-38, 00841268108394 These Micro-Introducer Kits are intended to introduce up to a .038 inch guidewire or catheter into the peripheral vascular system following a small gauge needle stick.

    FDA Recall
    Open, Classified ·Galt Medical Corporation·Product code OFL·March 27, 2025

    Introducer Kit- Tearaway MicroSlide REF KIT-051-01, 00841268106130 INT-101-15, 00841268107380 These introducers are used for the procedures to introduce catheters and other intravascular devices into the coronary and peripheral vasculature of adult and pediatric patients of all ages.

    FDA Recall
    Open, Classified ·Galt Medical Corporation·Product code OFL·March 27, 2025