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

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    EXTERNAL FIXATION CLAMP 5.0 MM PIN X9.5MM ROD, MODEL 1151-100, EXTERNAL FIXATON CLAMP, 9.5MM ROD

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    iDuo® Patella Sizer

    FDA UDI
    Conformis, Inc.·00850268007415·iDuo® 35mm Patella Sizer Reusable Instrument

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756045803·Foley Catheter with Temperature Sensor

    CANCELLO-PURE WEDGE

    FDA Adverse Event
    Other ·RTI BIOLOGICS·Product code MQV·November 20, 2009

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0840080·Distractor, Screw to Screw

    LIFESTYLES, CONTEMPO OR PRIVATE LABEL STRAWBERRY, VANILLA, OR BANANA FLAVORED CONDOM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SYSTEM 2000 CONTROLLER, SYSTEM 5000 CONTROLLER, FOOTSWITCH, POWER CORD, AND VISAGE WANDSFF

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

    FOLEY CATHETER, 400 SERIES 8 FR

    FDA Adverse Event
    Malfunction ·DEROYAL INDUSTRIES, INC.·Product code EYC·September 1, 2016

    FOLEY CATHETER, 400 SERIES 8 FR

    FDA Adverse Event
    Malfunction ·DEROYAL INDUSTRIES, INC.·Product code EYC·September 1, 2016

    FOLEY CATHETER, 400 SERIES 8 FR

    FDA Adverse Event
    Malfunction ·DEROYAL INDUSTRIES, INC.·Product code EYC·September 1, 2016

    FOLEY CATHETER, 400 SERIES 8 FR

    FDA Adverse Event
    Malfunction ·DEROYAL INDUSTRIES, INC.·Product code EYC·September 1, 2016

    FOLEY CATHETER, 400 SERIES 8 FR

    FDA Adverse Event
    Malfunction ·DEROYAL INDUSTRIES, INC.·Product code EYC·September 1, 2016

    FOLEY CATHETER WITH TEMPERATURE SENSOR

    FDA Adverse Event
    Malfunction ·DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L.·Product code EYC·September 9, 2019

    VISION HOLLOW FIBER OXYGENATOR

    FDA Adverse Event
    Malfunction ·GISH BIOMEDICAL, INC.·Product code DTZ·February 18, 2011

    PINNACLE MTL INS NEUT36IDX52OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·April 26, 2013

    VIBRANT SOUNDBRIDGE

    FDA Adverse Event
    Injury ·VIBRANT MED-EL HEARING TECHNOLOGY GMBH·Product code MPV·April 22, 2011

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR INC.- REDWOOD CITY·Product code MGB·July 22, 2008

    FOLEY CATHETER, 400 SERIES 8 FRENCH

    FDA Adverse Event
    Malfunction ·DEGANIA MEDICAL DEVICES PVT. LTD.·Product code EYC·November 29, 2018

    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