BEUDAMED
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    TurboHawk

    FDA UDI
    Covidien LP·00821684047149·Peripheral Plaque Excision System;Large Vessel ...

    TurboHawk™

    FDA UDI
    MEDTRONIC, INC.·00643169968424·ATHERECTOMY TH-LX-M TURBOHAWK ATK SC UNI

    TurboHawk™

    FDA UDI
    MEDTRONIC, INC.·00763000918934·ATHERECTOMY TH-LX-M TURBOHAWK ATK SC UNI

    TurboHawk™

    FDA UDI
    Covidien LP·00821684065754·ATHERECTOMY TH-LX-M TURBOHAWK ATK V06

    SILVERHAWK POWERCROSS

    FDA Adverse Event
    Malfunction ·EV3 ENDOVASCULAR·Product code MCW·February 5, 2014

    SILVERHAWK® PLAQUE EXCISION SYSTEM

    FDA Adverse Event
    Injury ·EV3 INC.·Product code MCW·December 12, 2011

    LINX Reflux Management System, Implant Clasp, 13-16 Bead, 1.5T, Product Code LXM-xx, sterile, Rx only. Labeled as: a. Product Code LXM-13; b. Product Code LXM-14; c. Product Code LXM-15; d. Product Code LXM-16; Laparoscopic, fundic-sparing anti-reflux procedure indicated for patients diagnosed with Gastroesophageal Reflux Disease (GERD) as defined by abnormal pH testing, and who are seeking an alternative to continuous acid suppression therapy (i.e. proton pump inhibitors or equivalent) in the management of their GERD.

    FDA Enforcement
    Class II ·Terminated·Torax Medical, Inc.·June 6, 2018

    TURBOHAWK LXM

    FDA Adverse Event
    Malfunction ·COVIDIEN INC.·Product code MCW·August 29, 2014

    SILVERHAWK LX-M PLAQUE EXCISION SYSTEM

    FDA Adverse Event
    Injury ·FOX HOLLOW TECHNOLOGIES·Product code MCW·November 18, 2008

    TURBOHAWK¿ PLAQUE EXCISION SYSTEM

    FDA Adverse Event
    Injury ·EV3 INC.·Product code MCW·April 22, 2011

    SILVERHAWK ATK

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code MCW·April 4, 2016

    SILVERHAWK LX-M PLAQUE EXCISION SYSTEM

    FDA Adverse Event
    Other ·EV3 INC.·Product code MCW·December 14, 2010

    LINX Reflux Management System, Implant Clasp, 13-16 Bead, 1.5T, Product Code LXM-xx, sterile, Rx only. Labeled as: a. Product Code LXM-13; b. Product Code LXM-14; c. Product Code LXM-15; d. Product Code LXM-16; Laparoscopic, fundic-sparing anti-reflux procedure indicated for patients diagnosed with Gastroesophageal Reflux Disease (GERD) as defined by abnormal pH testing, and who are seeking an alternative to continuous acid suppression therapy (i.e. proton pump inhibitors or equivalent) in the management of their GERD.

    FDA Recall
    Terminated ·Torax Medical, Inc.·Product code LEI·April 20, 2018

    SILVERHAWK LX-M

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code MCW·November 5, 2015

    SILVERHAWK LX-M

    FDA Adverse Event
    Malfunction ·PLYMOUTH·Product code MCW·November 23, 2015

    SILVERHAWK LX-M

    FDA Adverse Event
    Malfunction ·PLYMOUTH·Product code MCW·November 27, 2015

    SILVERHAWK LX-M

    FDA Adverse Event
    Malfunction ·PLYMOUTH·Product code MCW·November 23, 2015

    SILVERHAWK LX-M

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code MCW·November 12, 2015

    SILVERHAWK LX-M PLAQUE EXCISION SYSTEM

    FDA Adverse Event
    Injury ·EV3 INC.·Product code MCW·February 9, 2010

    ATK TURBOHAWK SMOOTH

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code MCW·September 2, 2025