BEUDAMED
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    NML-TETRA-TUBE RIA

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CODMAN®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780536734·CODMAN® Shunt Connector Titanium

    CODMAN®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780518877·CODMAN® Shunt Connector Titanium

    CODMAN

    FDA UDI
    Cerenovus, Inc.·10886704041290·CODMAN Shunt Connector

    APEXLINE OF PULMONARY FUNCT. INSTRUM.

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DYONICS VISION 635 IMAGE MANAGEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SHUNT CONNECTOR TITANIUM STRL

    FDA Adverse Event
    Injury ·INTEGRA LIFESCIENCES MANSFIELD·Product code JXG·December 11, 2023

    PLUM A+ 3 MEDNET SW

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·February 19, 2014

    PT²¿

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code DQX·November 7, 2012

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·June 6, 2015

    HAKIM PERITON CATH,120CM

    FDA Adverse Event
    Injury ·INTEGRA LIFESCIENCES MANSFIELD·Product code JXG·November 22, 2023

    HAKIM PERITON CATH,120CM

    FDA Adverse Event
    Injury ·INTEGRA LIFESCIENCES SWITZERLAND SAR·Product code JXG·May 20, 2021

    PROG VALVE INLINE

    FDA Adverse Event
    Injury ·INTEGRA LIFESCIENCES MANSFIELD·Product code JXG·December 11, 2023

    HAKIM PROGRAMMABLE VALVE

    FDA Adverse Event
    Injury ·INTEGRA LIFESCIENCES MANSFIELD·Product code JXG·December 27, 2023

    MEDOS PROG INFANT VALVESYSTEM

    FDA Adverse Event
    Injury ·INTEGRA LIFESCIENCES SWITZERLAND SAR·Product code JXG·May 20, 2021

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022

    Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012