BEUDAMED
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    EkoSonic®

    FDA UDI
    EKOS CORPORATION·00858593006493·The EkoSonic® Control Unit provides power to th...

    EkoSonic®

    FDA UDI
    EKOS CORPORATION·00858593006509·The Connector Interface Cable (CIC) is the cabl...

    EKOS CORPORATION

    FDA Adverse Event
    Injury ·EKOS CORPORATION·Product code KRA·December 9, 2013

    EKOSONIC ENDOVASCULAR CATHETER

    FDA Adverse Event
    Malfunction ·EKOS CORP.·Product code KRA·November 17, 2015

    EKOSONIC ENDOVASCULAR CATHETER

    FDA Adverse Event
    Malfunction ·EKOS CORPORATION·Product code KRA·May 7, 2018

    EkoSonic MACH4 Endovascular Device (Catalog #500-55106, 500-55112; 500-55118; 500-55124; 500-55130; 500-55140; 500-55150; 500-54106; 500-56130; 500-56140; 500-56150) is a catheter, continuous infusion. it consists of the Intelligent Drug Delivery Catheter (IDDC) and the MicroSonic Device (MSD). It is intended for the controlled and selective infusion of physician-specific fluids, including thrombolytics, into the peripheral vasculature. All therapeutic agents utilized with the EkoSonic Endovascular System should be fully prepared and used according to the instruction for use of the specific therapeutic agent. The Kit MACH4 is labeled in parts: "***EkoSonic MACH4 Endovascular Device***MicroSonic Device and Intelligent Drug Delivery Catheter***". The Pouch MSD is labeled in parts: "***EKOS***MicroSonic Device***Sterile***". EkoSonic Endovascular System is a catheter, continuous infusion. It is intended for the controlled and selective infusion of physician-specific fluids, including thrombolytics, into the peripheral vasculature. The system is also intended for the infusion of solutions into pulmonary arteries.

    FDA Recall
    Terminated ·EKOS Corporation·Product code KRA·May 24, 2012

    The EkoSonic Endovascular System employs high frequency (2-2.5 MHz), low power (0.585 watt average power per transducer) ultrasound to facilitate the delivery of physician-specified fluids in the peripheral vasculature and to deliver solutions into the pulmonary arteries. The EkoSonic Endovascular System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature and the infusion of solutions into the pulmonary arteries. The reusable EKOS EkoSonic Control Unit provides power to the system and the user interface for operator control. A reusable, non sterile Connector Interface Cable connects the EKOS EkoSonic Control Unit to the EkoSonic Endovascular Device.

    FDA Recall
    Terminated ·EKOS Corporation·Product code KRA·October 2, 2013

    The EKOS cart has the catalog number 700-60101. The EKOS cart is a custom infusion stand/cart used to hold and transport the EkoSonic Control Unit. The cart is designed with three poles to hold infusion pumps and fluid bags, a tray on which the EkoSonic Control unit sits and a base designed to hold an Uninterruptable Power Supply (UPS). The cart mounts on 4 wheels, two locking and two non-locking.

    FDA Recall
    Terminated ·EKOS Corporation·Product code FOX·August 22, 2016

    EKOSONIC ENDOVASCULAR CATHETER

    FDA Adverse Event
    Injury ·EKOS CORPORATION·Product code KRA·December 18, 2017

    EKOSONIC ENDOVASCULAR CATHETER

    FDA Adverse Event
    Injury ·EKOS CORPORATION·Product code KRA·December 15, 2017

    EKOSONIC KIT 106CM 40CM TZ

    FDA Adverse Event
    Injury ·EKOS CORPORATION·Product code KRA·May 13, 2021

    EKOSONIC KIT 135CM 50CM TZ

    FDA Adverse Event
    Malfunction ·EKOS CORPORATION·Product code KRA·April 23, 2021

    CATHETER, CONTINUOUS FLUSH

    FDA Adverse Event
    Injury ·EKOS CORPORATION·Product code KRA·May 13, 2021

    EKOSONIC ENDOVASCULAR CATHETER

    FDA Adverse Event
    Malfunction ·EKOS CORPORATION·Product code KRA·October 9, 2017

    EKOSONIC ENDOVASCULAR CATHETER

    FDA Adverse Event
    Malfunction ·EKOS CORPORATION·Product code KRA·October 23, 2017

    EKOSONIC KIT 135CM 50CM TZ

    FDA Adverse Event
    Injury ·EKOS CORPORATION·Product code KRA·April 19, 2021

    EKOSONIC KIT 106CM 12CM TZ

    FDA Adverse Event
    Malfunction ·EKOS CORPORATION·Product code KRA·June 11, 2021

    EKOSONIC ENDOVASCULAR SYSTEM

    FDA Adverse Event
    Malfunction ·EKOS CORPORATION·Product code KRA·April 6, 2012

    EKOSONIC ENDOVASCULAR SYSTEM

    FDA Adverse Event
    Malfunction ·EKOS CORPORATION·Product code KRA·April 6, 2012

    EKOSONIC ENDOVASCULAR SYSTEM

    FDA Adverse Event
    Malfunction ·EKOS CORPORATION·Product code KRA·April 6, 2012