BEUDAMED
    16 results · 32ms · Sources: EU EUDAMED, US FDA

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    STERI-VERS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    IMAGEN PARAINFLUENZA VIRUS TYPES 1, 2, 3

    FDA UDI
    OXOID LIMITED·05032384502967·

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345024069·Paddle Shaver, 11mm

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0103110·Shaver, Closed, 11mm

    iNSitu™ Hip System

    FDA UDI
    NEXTSTEP ARTHROPEDIX, LLC·00816127027970·Neck Trial, Size 11, Standard, Dual Taper

    Home Use IPL Beauty Device, Model(s): MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6, MELSYA-M7.

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

    LIPOMATIC; LIPOMATIC LIPOSUCTION DEVICE

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

    GALAXY G3 MINI 1MM X 2CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·December 5, 2020

    L.C. 5000/CE NITROGL

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·July 27, 2009

    NITRO I.V. DC INF. SET W/LB TBG

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·May 16, 2011

    L.C. 5000/CE NITROGLYCERIN PUM

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·February 22, 2012

    MENTOR SMOOTH ROUND MODERATE PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·March 9, 2020

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·January 9, 2014

    INTERSTIM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code EZW·October 31, 2012

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code DYE·August 20, 2010

    Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Numbers: CD1241-40 and CD1241-40Q; Fortify Assura VR, Model Numbers: CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q; Fortify Assura ST VR, Model Numbers: CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q; Fortify DR, Model Numbers: CD2231-40 and CD2231-40Q; Fortify ST DR, Model Numbers: CD2241-40 and CD2241-40Q; Fortify Assura DR, Model Numbers: CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q; Fortify Assura ST DR, Model Numbers: CD2263-40, CD2263-40Q, CD2363-40C, CD2363-40Q Product Usage Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·October 18, 2017