BEUDAMED
    228 results · 10ms · Sources: EU EUDAMED, US FDA

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    This reagent is for in vitro diagnostic use. Pax-5 (1EW) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Pax-5 in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated Bond system.

    FDA Enforcement
    Class II ·Terminated·Leica Microsystems, Inc.·March 2, 2016

    Cell Marque, PAX8 (MRQ-50 Mab.), 7 mL, REF PA0808, IVD, This antibody is intended for in vitro diagnostic (IVD) use. PAX-8 (MRQ-50) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the PAX-8 protein in formalin-fixed, paraffin-embedded tissue stained in qualitative immunohistochemistry (IHC) testing

    FDA Enforcement
    Class II ·Terminated·Leica Biosystems Richmond Inc.·September 20, 2017

    Cell Marque, PAX8 (MRQ-50 Mab.), 7 mL, REF PA0808, IVD, This antibody is intended for in vitro diagnostic (IVD) use. PAX-8 (MRQ-50) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the PAX-8 protein in formalin-fixed, paraffin-embedded tissue stained in qualitative immunohistochemistry (IHC) testing

    FDA Recall
    Terminated ·Leica Biosystems Richmond Inc.·Product code NJT·July 14, 2017

    GE Healthcare Discovery IQ X-ray system

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code KPS·May 19, 2017

    This reagent is for in vitro diagnostic use. Pax-5 (1EW) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Pax-5 in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated Bond system.

    FDA Recall
    Terminated ·Leica Microsystems, Inc.·Product code NJT·December 30, 2015

    GE Healthcare Discovery IQ X-ray system

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·June 21, 2017

    Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arterial catheterization device permits access to the peripheral arterial circulation.

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·July 20, 2016

    Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arterial catheterization device permits access to the peripheral arterial circulation.

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·July 20, 2016

    Omega IV and Omega V tables on GE Innova 4100/4100IQ GE Innova 4100 / 4100 IQ., x-ray system

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code MQB·December 22, 2009

    Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arterial catheterization device permits access to the peripheral arterial circulation.

    FDA Recall
    Terminated ·Arrow International Inc·Product code DQX·June 2, 2016

    Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arterial catheterization device permits access to the peripheral arterial circulation.

    FDA Recall
    Terminated ·Arrow International Inc·Product code DQX·June 2, 2016

    Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387307, .035/150cm, stiff/straight/standard, sold as a single hydrophilic guidewire in both sterile and bulk non-sterile packaging configurations. Argon Medical Devices, Inc. Athens, TX 75751

    FDA Recall
    Terminated ·Argon Medical Devices, Inc·Product code DQX·November 19, 2007

    Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087316, .038/150 cm, regular/angled/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Argon Medical Devices, Inc. Athens, TX 75751.

    FDA Recall
    Terminated ·Argon Medical Devices, Inc·Product code DQX·February 26, 2009

    Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087308, .035/180 cm, stiff/straight/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Argon Medical Devices, Inc. Athens, TX 75751.

    FDA Recall
    Terminated ·Argon Medical Devices, Inc·Product code DQX·February 26, 2009

    AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Regular. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature.

    FDA Recall
    Terminated ·Nipro Medical Corporation·Product code DQX·July 27, 2012

    Merit Laureate 0.035" (0.89mm) Hydrophilic Guide Wire, Angled Tip, Standard Shaft, Catalog No. LWSTDA35260EX, 260 cm (102").

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code DQX·April 14, 2014

    HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile.Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Straight Tip, 180 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. Manufactured in Costa Rica The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.

    FDA Recall
    Terminated ·Nitinol Devices and Components, Inc.·Product code DQX·May 28, 2014

    HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Angled Tip, 260 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. Manufactured in Costa Rica The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.

    FDA Recall
    Terminated ·Nitinol Devices and Components, Inc.·Product code DQX·May 28, 2014

    Merit Laureate Hydrophylic Guide Wire, Straight, Made In Ireland, CAT No: LWSTFS35180, 180cm, Sterile EO, Merit Medical Systems, Inc., South Jordan, UT 84095. Intended to facilitate the placement of devices during diagnostic and interventional procedures.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code DQX·June 28, 2010

    Merit Laureate Hydrophylic Guide Wire, Angled, Made In Ireland, CAT No: LWSTDA35180, 180cm, Sterile EO, Merit Medical Systems, Inc., South Jordan, UT 84095. Intended to facilitate the placement of devices during diagnostic and interventional procedures.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code DQX·June 28, 2010