BEUDAMED
    59 results · 18ms · Sources: EU EUDAMED, US FDA

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    VARIOTHERM

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    ACUMED

    FDA UDI
    Acumed LLC·10806378042201·LE Modular System Base

    NAR Kit

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209101986·KIT, K9 HANDLER IFAK - ODG

    NOVASURE

    FDA Adverse Event
    Malfunction ·HOLOGIC·Product code MNB·October 4, 2010

    ACTI-GARD ANTIMICROBIAL FILM, MODELS D6635, D6640, D6648, D6650,D6651, D66XX

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SERISCAFFOLD SURGICAL MESH

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PROLIFT PELVIC FLOOR REPAIR

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·October 22, 2012

    UNSPECIFIED BY THE COMPLAINANT

    FDA Adverse Event
    Injury ·COOK BIOTECH, INC.·Product code PAG·April 3, 2014

    ACCU-CHEK ® AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·August 16, 2010

    Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies.

    FDA Recall
    Terminated ·Hologic, Inc·Product code KNW·August 22, 2016

    SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. SURESOUND22 Multipack (OUS Distribution) containing 2 packs of six devices. For uterine sound

    FDA Recall
    Terminated ·Hologic, Inc·Product code HHM·October 28, 2016

    Crimson Trace Corporation laser sights. The Finished Products are laser sighting systems for firearms, used for personal defense and target acquisition.

    FDA Recall
    Terminated ·Crimson Trace Corporation·Product code REU·October 10, 2017

    LIFEPAK 1000 defibrillator. Affected Part Numbers: 320371500XXX The LP1000 (in AED mode) is indicated for use on patients in cardiac arrest.

    FDA Recall
    Terminated ·Physio-Control, Inc.·Product code MKJ·May 9, 2014

    Physio-Control Lifepak 20 defibrillator/monitor is intended for the termination of certain fatal arrhythmias.

    FDA Recall
    Terminated ·Physio Control, Inc.·Product code MKJ·June 18, 2008

    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

    Medtronic Physio-Control LIFEPAK CR Plus Defibrillator/Monitor. Automated external defibrillator deployed primarily in public access defibrillator environments where the expected use for any one device is once every 20 months. For use on persons requiring defibrillation therapy.

    FDA Recall
    Terminated ·Physio Control, Inc.·Product code MKJ·July 31, 2009

    Physio-Control LIFEPAK 20e defibrillator/monitor. This product is an external defibrillator sold internationally only

    FDA Recall
    Terminated ·Physio Control, Inc.·Product code LDD·May 13, 2008

    Physio-Control LIFEPAK 20 defibrillator/monitor. This product is an external defibrillator sold internationally and domestically.

    FDA Recall
    Terminated ·Physio Control, Inc.·Product code LDD·May 13, 2008

    LIFEPAK 20 defibrillator/monitor. Product Part numbers: 3202487-xxx, 3202488-xxx, U3202487-000, 3202488-015, and U3202488-000.

    FDA Recall
    Terminated ·Physio Control, Inc.·Product code MKJ·May 27, 2010