BEUDAMED
    130 results · 49ms · Sources: EU EUDAMED, US FDA

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    TALENT II

    FDA Adverse Event
    Injury ·ELA MEDICAL, S.A.·Product code DXY·August 29, 2004

    TALENT II

    FDA Adverse Event
    Injury ·ELA MEDICAL, S.A.·Product code DXY·January 9, 2004

    BRIO

    FDA Adverse Event
    Injury ·ELA MEDICAL, S.A.·Product code DXY·December 16, 2003

    LYRA

    FDA Adverse Event
    Injury ·ANGEION CORP·Product code LWS·August 29, 2002

    BRIO

    FDA Adverse Event
    Injury ·ELA MEDICAL, S.A.·Product code DXY·June 2, 2004

    STELA

    FDA Adverse Event
    Injury ·ELA MEDICAL, S.A.·Product code DTB·December 16, 2003

    SENTINEL

    FDA Adverse Event
    Injury ·ANGEION CORPORATION·Product code LWS·July 19, 2004

    BRIO

    FDA Adverse Event
    Death ·ELA MEDICAL, S.A.·Product code DXY·March 5, 2004

    SYMPHONY

    FDA Adverse Event
    Other ·ELA MEDICAL S.A.S.·Product code DXY·February 24, 2006

    LYRA

    FDA Adverse Event
    Death ·ANGEION CORP.·Product code LWS·August 4, 2003

    SYMPHONY

    FDA Adverse Event
    Injury ·ELA MEDICAL·Product code DXY·July 15, 2005

    TALENT

    FDA Adverse Event
    Injury ·ELA MEDICAL, S.A.·Product code DXY·September 17, 2003

    TURBO-ELITE LASER ATHERECTOMY CATHETER

    FDA Adverse Event
    Injury ·SPECTRANETICS CORPORATION·Product code MCW·May 28, 2024

    TURBO-ELITE LASER ATHERECTOMY CATHETER

    FDA Adverse Event
    Injury ·SPECTRANETICS CORPORATION·Product code MCW·May 28, 2024

    PY2 PERMANENT PACING LEAD

    FDA Adverse Event
    Injury ·OSCOR INC.·Product code DTB·October 21, 2020

    Sorin Group Reply DR Rate responsive dual-chamber pacemaker. Made in Italy by: Sorin BioMedica CRM S.r.l., Via Crescentino s.n., 13040 Saluggia (VC) Italy. ELA Medical, Inc., 14401 West 65th Way, Arvada, CO 80004, USA. REPLY DR is a DDDR-type dual-chamber rate-responsive pacemaker. It is equipped with a physiological sensor and an accelerometer to allow adaptation of pacing to suit the patient's activity. The REPLY device can be programmed to separate pacing and sensing polarities, independent of chamber.

    FDA Recall
    Terminated ·ela Medical Llc·Product code NVZ·September 23, 2008

    DEVICE #1 TALENT

    FDA Adverse Event
    Injury ·ELA MEDICAL, INC.·Product code DXY·December 11, 2003

    STELA LEAD

    FDA Adverse Event
    Injury ·ELA MEDICAL, INC.·Product code DTB·December 11, 2003

    ALTO

    FDA Adverse Event
    Injury ·ELA MEDICAL, INC.·Product code MRM·July 1, 2003

    FOCUS

    FDA Adverse Event
    Injury ·ELA MEDICAL, INC.·Product code DTB·July 1, 2003