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    SOZO

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LeMaitre Embolectomy Catheter

    FDA UDI
    Lemaitre Vascular, Inc.·00840663101009·2F 60 cm NovaSil Silicone Single Lumen Embolect...

    LeMaitre Embolectomy Catheter

    FDA UDI
    Lemaitre Vascular, Inc.·00840663100880·2F 60 cm NovaSil Silicone Single Lumen Embolect...

    Super Upper Limbs Versalock Plating System

    FDA UDI
    GM DOS REIS INDUSTRIA E COMERCIO LTDA·07899258663647·VERSALOCK “Y” DISTAL ULNA MINI PLATE 95.0mm

    PedFuse®

    FDA UDI
    SPINEFRONTIER, INC.·00190361011897·PedFuse Respond, SLD, 5.0mm x 40mm

    PedFuse®

    FDA UDI
    SPINEFRONTIER, INC.·00190361011910·PedFuse Respond, SLD, 5.0mm x 50mm

    PedFuse®

    FDA UDI
    SPINEFRONTIER, INC.·00190361011880·PedFuse Respond, SLD, 5.0mm x 35mm

    PedFuse®

    FDA UDI
    SPINEFRONTIER, INC.·00190361011903·PedFuse Respond, SLD, 5.0mm x 45mm

    STELLATE GRIDVIEW

    FDA 510(k)
    FDA Class 2 ·Neurology

    DIO PROTEM IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    ONE TOUCH ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·March 19, 2002

    ONE TOUCH ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·September 30, 2003

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code PQF·February 23, 2018

    NOVOSTITCH CARTRIDGE 2-0

    FDA Adverse Event
    Malfunction ·CETERIX ORTHOPAEDICS, INC·Product code GAT·May 9, 2019

    EVIS EXERA II BRONCHOVIDEOSCOPE

    FDA Adverse Event
    Injury ·OLYMPUS MED SYSTEMS CORP·Product code EOQ·October 15, 2014

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 4, 2013

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·July 27, 2011

    LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 2F, 60 cm, Model e1801-26. Indicated for the removal of arterial emboli and thrombi.

    FDA Enforcement
    Class II ·Terminated·LeMaitre Vascular, Inc.·December 16, 2015

    LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 2F, 60 cm, Model e1801-26. Indicated for the removal of arterial emboli and thrombi.

    FDA Recall
    Terminated ·LeMaitre Vascular, Inc.·Product code DXE·October 21, 2015

    VIDAS® HS TROPONIN I

    FDA Adverse Event
    Injury ·BIOMERIEUX SA·Product code MMI·May 10, 2017