BEUDAMED
    14 results · 17ms · Sources: EU EUDAMED, US FDA

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    BASIC LIGHT

    FDA 510(k)
    FDA Class 1 ·General Hospital

    NA

    FDA UDI
    Philips Medical Systems Hsg·00884838006652·HeartStart MRx ALS monitor

    ARROW PRESSURE INJECTABLE PICC

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DURAFIBER Ag

    FDA 510(k)
    FDA Unclassified ·Unknown

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·June 10, 2014

    SHUNT SENSOR SYS500

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·October 5, 2010

    VIRTUOSAPH PLUS, EVH

    FDA Adverse Event
    Injury ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code GCJ·December 5, 2012

    Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·June 14, 2017

    HeartStart MRx Monitor/Defibrillator, Model No. M3535A (861288), M3536A (861289) Product Automated external defibrillators (non-wearable) Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·June 6, 2018

    M3536A HeartStart MRx with Wireless Link Upgrade (861289) The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.

    FDA Recall
    Terminated ·Philips Medical Systems, Inc.·Product code MKJ·February 18, 2014

    M3536A HeartStart MRx with Wireless Link Upgrade (861289) The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems, Inc.·March 5, 2014

    HeartStart MRx Monitor/Defibrillator, Model No. M3535A (861288), M3536A (861289) Product Automated external defibrillators (non-wearable) Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.

    FDA Recall
    Terminated ·Philips Electronics North America Corporation·Product code MKJ·May 3, 2018

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012