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    LINX

    FDA UDI
    Torax Medical, Inc.·00855106005165·

    LINX

    FDA UDI
    Torax Medical, Inc.·00855106005158·

    LINX

    FDA UDI
    Torax Medical, Inc.·00855106005189·

    LINX

    FDA UDI
    Torax Medical, Inc.·00855106005134·

    LINX

    FDA UDI
    Torax Medical, Inc.·00855106005172·

    LINX

    FDA UDI
    Torax Medical, Inc.·00855106005141·

    TurboHawk™

    FDA UDI
    Covidien LP·00821684074008·ATHERECTOMY THS-LX-C TURBOHAWK ATK V08

    TurboHawk™

    FDA UDI
    MEDTRONIC, INC.·00643169968400·ATHERECTOMY THS-LX-C TURBOHAWK ATK HEC U

    TurboHawk

    FDA UDI
    Covidien LP·00821684047200·Peripheral Plaque Excision System;Large Vessel ...

    ATK TURBOHAWK

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code MCW·November 16, 2015

    TOMOSCAN LX/C

    FDA Adverse Event
    Injury ·HITACHI MEDICAL SYSTEMS·Product code JAK·February 11, 1997

    SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) CALIBRATOR

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JIS·December 20, 2011

    TURBOHAWK¿ PLAQUE EXCISION SYSTEM

    FDA Adverse Event
    Injury ·EV3 INC.·Product code MCW·July 25, 2011

    LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code LXC-xx, sterile, Rx only. Labeled as: a. Product Code LXC-12; b. Product Code LXC-13; c. Product Code LXC-14; d. Product Code LXC-15; e. Product Code LXC-16; f. Product Code LXC-17; 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

    LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code LXC-xx, sterile, Rx only. Labeled as: a. Product Code LXC-12; b. Product Code LXC-13; c. Product Code LXC-14; d. Product Code LXC-15; e. Product Code LXC-16; f. Product Code LXC-17; 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

    RESOLUTE ONYX RX

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NIQ·January 28, 2019

    RESOLUTE ONYX RX

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NIQ·January 28, 2019

    SYNERGY

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NIQ·June 30, 2021

    APEX MONORAIL

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code LOX·October 22, 2008

    SYNERGY

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC CORPORATION·Product code NIQ·August 9, 2022