BEUDAMED
    11 results · 8ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Enforcement × Classification: Class I × Clear all

    TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System; Two 1 g tubes of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-400; The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical devascularization is desired.

    FDA Enforcement
    Class I ·Terminated·Codman & Shurtleff, Inc.·January 29, 2014

    TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System: One 1 g tube of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-500 The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical devascularization is desired. The system is used under fluoroscopic guidance to obstruct or reduce blood flow to cerebral arteriovenous malformations (AVMs) via superselective catheter delivery.

    FDA Enforcement
    Class I ·Terminated·Codman & Shurtleff, Inc.·January 29, 2014

    TruSignal Adult/Pediatric Sensor; Oximeter, Ear: a) REF TS-AP-10, 10 pcs; b) REF TS-AP-25, 25 pcs

    FDA Enforcement
    Class I ·Ongoing·GE Healthcare Finland Oy·July 12, 2023

    TruSignal Integrated Ear Sensor with GE Connector REF TS-E2-GE; Oximeter, Ear

    FDA Enforcement
    Class I ·Ongoing·GE Healthcare Finland Oy·July 12, 2023

    TruSignal Ear Sensor, REF TS-E-D; Oximeter

    FDA Enforcement
    Class I ·Ongoing·GE Healthcare Finland Oy·July 12, 2023

    TruSignal Sensitive Skin Sensor, REF TS-SE-3; Oximeter

    FDA Enforcement
    Class I ·Ongoing·GE Healthcare Finland Oy·July 12, 2023

    TruSignal Wrap Sensor, REF TS-W-D; Oximeter

    FDA Enforcement
    Class I ·Ongoing·GE Healthcare Finland Oy·July 12, 2023

    TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE; Monitor, physiological, patient(with arrhythmia detection or alarms)

    FDA Enforcement
    Class I ·Ongoing·GE Healthcare Finland Oy·July 12, 2023

    TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-N; Oximeter

    FDA Enforcement
    Class I ·Ongoing·GE Healthcare Finland Oy·July 12, 2023

    TruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs; B) REF AF-25, 25 pcs; Oximeter

    FDA Enforcement
    Class I ·Ongoing·GE Healthcare Finland Oy·July 12, 2023

    TruSignal Integrated Ear Sensor with Ohmeda Connector REF TS-E4-H; Oximeter

    FDA Enforcement
    Class I ·Ongoing·GE Healthcare Finland Oy·July 12, 2023