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    LINICAL ENZYME CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON SYSTEMS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257124673·15-20 MV FOR MEN CLSC CALF STD BLACK V

    CD HORIZON® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00885074036670·BONE SCREW 7040535 ILIAC 5.5X35 TI

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257141182·15-20 MFW VITALITY CALF CT EBONY V

    Greenwald Surgical Company, Inc.

    FDA UDI
    GRACE MANUFACTURING, INC.·10801334013462·Ball tip electrode for flexible ureteroscopes a...

    TRIFIX SPINAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    QUANTA LITE LKM-1 ELISA

    FDA 510(k)
    FDA Class 2 ·Immunology

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 29, 2022

    MICROPLEX 10-SYSTEM COIL (MCS)

    FDA Adverse Event
    Malfunction ·MICROVENTION, INC.·Product code HCG·April 3, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·August 27, 2014

    PRECISE OTW NITINOL STENT

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code NIM·May 9, 2008

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FGE·July 3, 2017

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·January 4, 2018

    ZILVER 635 BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·June 1, 2018

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·May 23, 2018

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·September 12, 2017

    Integra Licox Brain Tissue Oxygen Monitoring; 1 x Dual Lumen Introducer Kit REF IP2; Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA. Used in direct monitoring of the partial pressure of oxygen.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·October 30, 2013

    Integra Licox Brain Tissue Oxygen Monitoring; 1 x Complete Brain Probe Kit REF IP1.P Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA. Used in direct monitoring of the partial pressure of oxygen.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·October 30, 2013

    ZILVER 635 BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·May 30, 2014

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FGE·July 2, 2014