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    LICOX PMO BRAIN MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    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

    Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IP2.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

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257124550·15-20 MV FOR MEN CLSC CALF STD GREY V

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257126585·15-20 MV FOR MEN SEL CALF STD GREY V

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690199670·Modular Knee Stem Pilot 23mm x 150mm

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319700488·Platypus (Radolf) Nail Pulling Forceps 5-1/2" (...

    TEMPTELLER INFRARED EAR THERMOMETER, MODEL CT-30/ CT-30DX

    FDA 510(k)
    FDA Class 2 ·General Hospital

    INSYTE CATHETER, INSYTE AUTOGUARD CATHETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Optetrak Logic

    FDA UDI
    Exactech, Inc.·10885862158260·

    LOGIC TIB INSERT IMPL CRC, SZ 3.5, 9MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·September 14, 2022

    LOGIC TIB INSERT IMPL CRC, SZ 3.5, 9MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·November 7, 2023

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·April 5, 2011

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·April 8, 2013

    DUROM ACETABULAR COMPONENT 58/52 CODE R

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·May 7, 2008

    LOGIC TIB INSERT IMPL CRC, SZ 3.5, 9MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·August 31, 2022

    OPTETRAK LOGIC

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·July 25, 2024

    OPTETRAK

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·July 25, 2024

    LOGIC CR TIB INSERT SLOPE +. SZ 3.5, 9 MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·November 14, 2024