BEUDAMED
    19 results · 23ms · Sources: EU EUDAMED, US FDA

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    ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000

    FDA 510(k)
    FDA Class 2 ·Immunology

    Eighteeth

    FDA UDI
    Changzhou Sifary Medical Technology Co., Ltd.·06941877822248·Surgical Headlight is worn on the doctor's head...

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810014608228·ALLEN, STERIS-AMSCO 2" STANDARD

    2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/4 HOLES/RIGHT

    FDA Adverse Event
    Injury ·SYNTHES ELMIRA·Product code HRS·September 5, 2017

    NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE

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

    HDM99

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    PASS LP

    FDA Adverse Event
    Injury ·MEDICREA INTERNATIONAL·Product code MNI·December 23, 2011

    PASS LP

    FDA Adverse Event
    Injury ·MEDICREA INTL.·Product code MNI·September 16, 2011

    PASS LP

    FDA Adverse Event
    Injury ·MEDICREA INTL.·Product code MNI·October 14, 2011

    PASS LP

    FDA Adverse Event
    Injury ·MEDICREA INTERNATIONAL·Product code MNI·November 11, 2011

    PASS LP

    FDA Adverse Event
    Injury ·MEDICREA INTERNATIONAL·Product code MNI·April 5, 2012

    ACCU-CHEK ® MOBILE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·April 26, 2013

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·May 7, 2011

    ASR ACETABULAR CUPS 50

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·July 22, 2008

    PASS LP

    FDA Adverse Event
    Injury ·MEDICREA TECHNOLOGIES·Product code MNI·April 17, 2013

    PASS LP

    FDA Adverse Event
    Injury ·MEDICREA TECHNOLOGIES·Product code MNI·April 17, 2013

    PASS LP

    FDA Adverse Event
    Injury ·MEDICREA·Product code MNI·April 17, 2013

    InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). Product Usage: The InnerCool RTx device is a thermal regulating system intended to induce, maintain and reverse mild hypothermia, to achieve and/or maintain normothermia, and for use in fever reduction. K080908

    FDA Enforcement
    Class II ·Terminated·Philips Healthcare·February 5, 2014

    InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). Product Usage: The InnerCool RTx device is a thermal regulating system intended to induce, maintain and reverse mild hypothermia, to achieve and/or maintain normothermia, and for use in fever reduction. K080908

    FDA Recall
    Terminated ·Philips Healthcare·Product code NCX·January 13, 2014