BEUDAMED
    11 results · 60ms · 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.

    PHYSICAL THERAPY ULTRASOUND

    FDA Adverse Event
    Malfunction ·PHYSIO TECHNOLOGY INC·Product code IMG·March 2, 2001

    OMNISTIM 3020

    FDA Adverse Event
    Malfunction ·PHYSIO TECHNOLOGY INC.·Product code GZJ·February 23, 2009

    HEARTSINE GATEWAY 500P BUNDLE SALES BOM - UK ENGLISH

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·January 28, 2025

    LIFEPAK Express Automated External Defibrillator (AED). Labeling on the device states LIFEPAK CR Plus/LIFEPAK EXPRESS Defibrillators with ADAPTIV Biphasic Technology; Medtronic Emergency Response Systems, Inc. 11811 Willows Road NE Redmond, WA. The battery operated, small portable device is primarily deployed in Public Access Defibrillator (PAD) environments where the expected use for any one device is once every 20 months. Product is capable of 30 full discharges. LIFEPAK Express AEDs are intended for use on victims/patients in cardiac arrest. It includes a patented shock advisory system that notifies the user (i.e. minimally trained responder) if it detects a cardiac rhythm that requires a shock. The individual must be unresponsive (unconscious), not breathing normally, and showing no signs of circulation (for example, no pulse, no coughing, or no movement). With Infant/Child Reduced Energy Defibrillation Electrodes, the LIFEPAK Express AEDs may be used on children who are up to 8 years old or who weigh up to 25kg (55 lb). The device is designed specifically for infrequent use and for use by people whose only training is in CPR and in using AEDs.

    FDA Recall
    Terminated ·Physio Control, Inc.·Product code MKJ·July 24, 2008

    LIFEPAK CR Plus Automated External Defibrillator (AED). Labeling on the device states LIFEPAK CR Plus/LIFEPAK EXPRESS Defibrillators with ADAPTIV Biphasic Technology; Medtronic Emergency Response Systems, Inc. 11811 Willows Road NE Redmond, WA. The battery operated, small portable device is primarily deployed in Public Access Defibrillator (PAD) environments where the expected use for any one device is once every 20 months. Product is capable of 30 full discharges. LIFEPAK CR Plus AEDs are intended for use on victims/patients in cardiac arrest. It includes a patented shock advisory system that notifies the user (i.e. minimally trained responder) if it detects a cardiac rhythm that requires a shock. The individual must be unresponsive (unconscious), not breathing normally, and showing no signs of circulation (for example, no pulse, no coughing, or no movement). With Infant/Child Reduced Energy Defibrillation Electrodes, the LIFEPAK CR Plus AEDs may be used on children who are up to 8 years old or who weigh up to 25kg (55 lb). The device is designed specifically for infrequent use and for use by people whose only training is in CPR and in using AEDs.

    FDA Recall
    Terminated ·Physio Control, Inc.·Product code MKJ·July 24, 2008

    OMNI STIM

    FDA Adverse Event
    Malfunction ·PHYSIO TECHNOLOGIES, INC.·Product code IPF·July 23, 1996

    Advena Limited

    Authorized representative
    🇲🇹 Malta·467 Manufacturers·13717 Devices

    SC LIAMED SRL

    Importer
    🇷🇴 Romania·47 Manufacturers

    OMNISTIM STIMULATOR

    FDA Adverse Event
    Malfunction ·PHISIO TECHNOLOGIES, INC.·Product code GZJ·March 14, 1996

    Wellkang Ltd

    Authorized representative
    259 Manufacturers·3500 Devices

    MedPath GmbH

    Authorized representative
    🇩🇪 Germany·537 Manufacturers·13464 Devices