BEUDAMED
    81 results · 34ms · Sources: EU EUDAMED, US FDA

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    EVLT PROCEDURE KIT

    FDA Adverse Event
    Injury ·DIOMED INC.·Product code GEX·April 22, 2005

    EVLT OPTICAL FIBER

    FDA Adverse Event
    Injury ·DIOMED, INC.·Product code GEX·February 15, 2006

    EVLT PROCEDURE KIT

    FDA Adverse Event
    Injury ·DIOMED, INC.·Product code FOZ·November 12, 2005

    OPTIGUIDE

    FDA Adverse Event
    Malfunction ·DIOMED, INC.·Product code MVG·November 3, 2004

    OPTIGUIDE

    FDA Adverse Event
    Malfunction ·DIOMED, INC·Product code GEX·August 22, 2008

    EVLT II KIT

    FDA Adverse Event
    Injury ·DIOMED, INC.·Product code GEX·August 23, 2005

    DIOMED

    FDA Adverse Event
    Injury ·DIOMED INC.·Product code GEX·July 26, 2001

    PORT POWER INJECTABLE SMART PORT SYSTEM

    FDA Adverse Event
    Injury ·ANGIODYNAMICS/DIOMED INC.·Product code LJT·December 15, 2016

    PORT POWER INJECTABLE SMART PORT SYSTEM LOG58980

    FDA Adverse Event
    Injury ·ANGIODYNAMICS/DIOMED INC·Product code LJT·December 20, 2016

    VenaCureEVLT Perforator Vein Ablation Kit, CATALOG #: EVLT/PVAK, STERILE -- Manufactured for: AngioDynamics Inc. 603 Queensbury, NY 12804 USA, AngioDynamics UK Limited, Building 2000, Beach Drive, IQ Cambridge, Waterbeach, Cambridge, CB259TE, United Kingdom --- COMMON/USUAL NAME: Laser Surgical Instrument; CLASSIFICATION NAME: Powered Laser Surgical Instrument; DEVICE LISTING # D053485. --- Product Usage: The 810nm Diomed Laser and EVLT Procedure Kit are intended for use in the treatment of superficial vein reflux of the greater saphenous vein associated with varicosities. The Diomed D15 plus and D30 plus and EVLT Kits are indicated for treatment of incompetence and reflux of superficial veins in the lower extremity.

    FDA Recall
    Terminated ·Angiodynamics Worldwide Headquarters·Product code GEX·December 6, 2011

    Metasul¿ Durom¿ Femoral component Sterile, Rx

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·November 14, 2012

    DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network devices. It also allows information transfer between several CMS. Network connections consist of hardwired network cables and or WLAN connections. The DPM Central Station is used for remote monitor management, storing, printing, reviewing, or processing of information from net worked devices, and it is operated by medical personnel in hospitals or medical institutions.

    FDA Enforcement
    Class II ·Terminated·Mindray DS USA, Inc. d.b.a. Mindray North America·January 9, 2013

    HEMI-WALKER

    FDA Adverse Event
    Injury ·DURO-MED INDUSTRIES, INC.·Product code ITJ·April 18, 1997

    MATURE MART PILL SPLITTER

    FDA Adverse Event
    Malfunction ·DURO-MED INDUSTRIES, INC.·Product code OHY·March 28, 2000

    DURO-MED MOIST HEAT PAD

    FDA Adverse Event
    DURO-MED INDUSTRIES, INC.·Product code IMA·April 15, 1998

    SUR-FIT NATURA UROSTOMY POUCH W/ACCUSEAL TAP W/VALVE TRANSPARENT STANDARD W/1-SI

    FDA Adverse Event
    Malfunction ·CONVATEC DOM. REPUBLIC, INC.·Product code EXH·October 2, 2014

    SUR-FIT NATURA UROSTOMY POUCH W/ACCUSEAL TAP W/VALVE TRANSPARENT STANDARD W/1-SI

    FDA Adverse Event
    Malfunction ·CONVATEC DOM. REPUBLIC, INC.·Product code EXH·October 2, 2014

    SUR-FIT NATURA UROSTOMY POUCH W/ACCUSEAL TAP W/VLAVE OPAQUE STANDARD W/1-SIDED C

    FDA Adverse Event
    Malfunction ·CONVATEC DOM. REPUBLIC, INC.·Product code EXH·October 1, 2014

    SUR-FIT NATURA UROSTOMY POUCH WITH ACCUSEAL TAP W/VALVE TRANSPARENT STANDARD W/

    FDA Adverse Event
    Malfunction ·CONVATEC DOM. REPUBLIS, INC.·Product code EXH·October 2, 2014

    SUR-FIT PLUS TWO-PIECE UROSTOMY POUCH W/ACCUSEAL TAP

    FDA Adverse Event
    Malfunction ·CONVATEC DOM. REPUBLIC, INC.·Product code EXH·October 2, 2014