BEUDAMED
    10 results · 44ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Exo Imaging, Inc.

    FDA registration
    Exo Imaging, Inc.·5 products·🇺🇸 United States

    Exo Works

    FDA UDI
    Exo Imaging, Inc.·00850018318013·

    Exo Iris

    FDA UDI
    Exo Imaging, Inc.·00850018318006·Exo Iris is a hand-held, general-purpose diagno...

    Exo Iris Ultrasound System

    FDA UDI
    Exo Imaging, Inc.·00850018318068·Exo Iris Ultrasound System is a procedural pack...

    EcoGel 100 Imaging Gel, EcoGel 200 MultiPurpose Gel (Blue), EcoGel 200 MultiPurpose Gel (CLEAR), and EcoLotion Transmission Lotion 1) 100, 200 gel Intended for use in acoustic coupling of ultrasound transducer to tissue 2) Lotion Ecolotion transmission and massage lotion is intended to be used as an accessory to ultrasonic transducers and ultrasound monitors. Ecolotion is intended to be used externally only as a coupling medium for use in ultrasound procedures.

    FDA Enforcement
    Class I ·Ongoing·AMTEC SALES Inc·September 29, 2021

    EOS X-ray Medical Diagnostic , X-ray Equipment System Digital Radiography used in general radiographic examination.

    FDA Recall
    Terminated ·Eos Imaging Inc·Product code MQB·June 19, 2012

    EOS, Digital radiography system used in general radiographic examinations.

    FDA Recall
    Terminated ·Eos Imaging Inc·Product code MQB·February 17, 2015

    EOS X-ray Medical Diagnostic , X-ray Equipment System Digital Radiography used in general radiographic examination.

    FDA Enforcement
    Class II ·Terminated·Eos Imaging Inc·October 10, 2012

    EOS, Digital radiography system used in general radiographic examinations.

    FDA Enforcement
    Class II ·Terminated·Eos Imaging Inc·May 13, 2015

    EcoGel 100 Imaging Gel, EcoGel 200 MultiPurpose Gel (Blue), EcoGel 200 MultiPurpose Gel (CLEAR), and EcoLotion Transmission Lotion 1) 100, 200 gel Intended for use in acoustic coupling of ultrasound transducer to tissue 2) Lotion Ecolotion transmission and massage lotion is intended to be used as an accessory to ultrasonic transducers and ultrasound monitors. Ecolotion is intended to be used externally only as a coupling medium for use in ultrasound procedures.

    FDA Recall
    Open, Classified ·AMTEC SALES Inc·Product code ITX·August 12, 2021