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    41 results · 17ms · Sources: EU EUDAMED, US FDA

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    VitreQ 23G Silicone Tipped Cannula-CN23.D01 GTIN: 8719214221508

    FDA Recall
    Terminated ·Vitreq Bv Seggelant-Noord 2 Vierpolders Netherlands·Product code HMX·December 17, 2019

    CardioTek EP-TRACER Software V1.x and V2.0 The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.

    FDA Recall
    Completed ·CardioTek BV Amerikalaan 70 Maastricht-Airport Netherlands·Product code DQK·April 13, 2017

    (1) VitreQ 20G BF Blunt Needles-Ref: BF20.D51 GTIN: 8719214221089 (2) VitreQ 20G BF Brush Needles-REF: BF20.D52 GTIN: 8719214221102

    FDA Recall
    Terminated ·Vitreq Bv Seggelant-Noord 2 Vierpolders Netherlands·Product code GAA·December 17, 2019

    VitreQ 25G Blunt Needles with luer-lock connector-REF : CN25.D05 GTIN: 8719214221645

    FDA Recall
    Terminated ·Vitreq Bv Seggelant-Noord 2 Vierpolders Netherlands·Product code GAA·December 17, 2019

    VitreQ 23G VFI Cannula-REF: CN23.D03 GTIN: 8719214221423

    FDA Recall
    Terminated ·Vitreq Bv Seggelant-Noord 2 Vierpolders Netherlands·Product code HMX·December 17, 2019

    Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA inserts in human tissue, Model Number 40V016V495

    FDA Recall
    Open, Classified ·Kreatech Biotechnology Bv Vlierweg 20 Amsterdam Netherlands·Product code MVU·November 1, 2024

    VitreQ 23G Blunt Needles with luer-lock connector-REF: CN23.D05 GTIN: 8719214221621

    FDA Recall
    Terminated ·Vitreq Bv Seggelant-Noord 2 Vierpolders Netherlands·Product code GAA·December 17, 2019

    VitreQ 25G VFI Cannula-REF: CN25.D03 GTIN: 8719214221447

    FDA Recall
    Terminated ·Vitreq Bv Seggelant-Noord 2 Vierpolders Netherlands·Product code HMX·December 17, 2019

    VitreQ 25G Silicone Tipped Cannula-REF: CN25.D01 GTIN: 8719214221522

    FDA Recall
    Terminated ·Vitreq Bv Seggelant-Noord 2 Vierpolders Netherlands·Product code HMX·December 17, 2019

    CardioTek EP-TRACER Software V2.x.

    FDA Recall
    Completed ·CardioTek BV Amerikalaan 70 Maastricht-Airport Netherlands·Product code DQK·April 25, 2022

    VitreQ 20G VFI Cannula-REF: CN20.D03 GTIN: 8719214221485

    FDA Recall
    Terminated ·Vitreq Bv Seggelant-Noord 2 Vierpolders Netherlands·Product code HMX·December 17, 2019

    (1)VitreQ 25G BF Blunt Needles-BF25.D51 GITN: 8719214221164 (2) VitreQ 25G BF Brush Needles-BF25.D52 GTIN: 8719214221188

    FDA Recall
    Terminated ·Vitreq Bv Seggelant-Noord 2 Vierpolders Netherlands·Product code GAA·December 17, 2019

    VitreQ 25G PFC Injection Needle-Ref: MD25.D01 GTIN: 8719214221386

    FDA Recall
    Terminated ·Vitreq Bv Seggelant-Noord 2 Vierpolders Netherlands·Product code GAA·December 17, 2019

    VitreQ 27G Blunt Needles with luer-lock connector-REF: CN27.D05 GTIN:8719214221669

    FDA Recall
    Terminated ·Vitreq Bv Seggelant-Noord 2 Vierpolders Netherlands·Product code GAA·December 17, 2019

    (1) VitreQ 23G BF Blunt Needles-BF23.D51 GTIN#: 8719214221126 (2) VitreQ 23G BF Brush Needles-BF23.D52 GTIN#: 8719214221140

    FDA Recall
    Terminated ·Vitreq Bv Seggelant-Noord 2 Vierpolders Netherlands·Product code GAA·December 17, 2019

    VitreQ 25G Pick Needles-REF: CN25.D04 GTIN: 8719214221607

    FDA Recall
    Terminated ·Vitreq Bv Seggelant-Noord 2 Vierpolders Netherlands·Product code GAA·December 17, 2019

    VitreQ 23G Pick Needles-REF: CN23.D04 GTIN: 8719214221584

    FDA Recall
    Terminated ·Vitreq Bv Seggelant-Noord 2 Vierpolders Netherlands·Product code GAA·December 17, 2019

    Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V. Oncentra is a radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment and may be used to administer treatments after review and approval by qualified medical personnel.

    FDA Recall
    Terminated ·Nucletron BV Waardgelder 1 POBox 930 Veenendaal Netherlands·Product code MUJ·August 10, 2017

    There is a complaint regarding internal check cable guide mechanism failure for the Nucletron Flexitron brachytherapy afterloader system. Due to an obstruction during the check cable out drive, the internal guiding tube became displaced and the check cable became damaged. This issue could cause treatment interruption or in a very unlikely scenario, incorrect source positioning and radiation treatment errors.

    FDA Recall
    Terminated ·Nucletron BV Waardgelder 1 POBox 930 Veenendaal Netherlands·Product code JAQ·November 18, 2019

    Finapres Medical Systems Portapres with NiMh battery pack Product Usage: Continuously measure blood pressure, The Portapres can be worn on the body with a protective waist belt. The device can be used without mains; in that case a battery pack is used.

    FDA Recall
    Terminated ·FMS, Finapres Medical Systems BV Paasheuvelweg 34A 1105 BJ Amsterdam Netherlands·Product code DXN·July 6, 2012