BEUDAMED
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    Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good kit) The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.

    FDA Recall
    Terminated ·TELEFLEX MEDICAL INC·Product code QEW·January 11, 2022

    Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing components: PT-45509-S6, PT-45509-T The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.

    FDA Recall
    Terminated ·TELEFLEX MEDICAL INC·Product code QEW·January 11, 2022

    5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device, REF PT-65509-HFC containing components: PT-03000, PT-65509-S (PT-65509-S2 alternative), PT-01000-D (PT-01000-D2 alternative) The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.

    FDA Recall
    Terminated ·TELEFLEX MEDICAL INC·Product code QEW·January 11, 2022

    Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-12709-WC, containing components: PT-12709-CA, PT-12709-C, The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.

    FDA Recall
    Terminated ·TELEFLEX MEDICAL INC·Product code QEW·January 11, 2022

    Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-WC containing components: PT-65709-C, PT-03009, PT-65709-HS The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.

    FDA Recall
    Terminated ·TELEFLEX MEDICAL INC·Product code QEW·January 11, 2022

    Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-HFWC containing components: PT-65709-C, PT-03009, PT-65709-HFS The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.

    FDA Recall
    Terminated ·TELEFLEX MEDICAL INC·Product code QEW·January 11, 2022

    Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-W containing component: PT-65709-C The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.

    FDA Recall
    Terminated ·TELEFLEX MEDICAL INC·Product code QEW·January 11, 2022

    The D*Clot HD Rotational Thrombectomy System is a percutaneous catheter-based system available in 6 French. The disposable system consists of an outer sheath through which a rotatable radiopaque spiral shaft extends ending in an eccentric blunt distal tip. Once activated, the shaft rotates at approximately 10.000 RPMs to break thrombus into smaller particles, which can be simultaneously aspirated using a dedicated vacuum syringe. The catheter is a stand-alone system and is powered by a 4.5 VDC alkaline battery pack in the control unit.

    FDA Recall
    Open, Classified ·Mermaid Medical A/S Frydensbergvej 25 Stenlose Denmark·Product code QEW·May 1, 2024

    ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Catheter ClotTriever Thrombectomy System, Reference: IU-01011

    FDA Recall
    Open, Classified ·Inari Medical Oak Canyon·Product code QEW·July 19, 2024

    Artix MT Thrombectomy Device, REF: 32-102

    FDA Recall
    Open, Classified ·Inari Medical Oak Canyon·Product code QEW·April 8, 2025

    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

    Leksell Gamma Knife Perfexion, Article #715000. Teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IWB·July 2, 2007

    Leica Bond Aspirating Probe Cleaning System; an in vitro diagnostic immunohistochemistry probe cleaning reagent kit; Catalog No. CS9100; Leica Biosystems Newcastle Ltd., Balliol Business Park West, Benton Lane, Newcastle Upon Tyne NE12 8EW, United Kingdom. The Bond Aspirating Probe Cleaning System is intended for automated cleaning of aspirating probes on Bond-max and Bond-x instruments, using the aspirating probe cleaning protocol installed in Bond systems. Product Quantity Distributed (Int) 1 kit

    FDA Recall
    Terminated ·Leica Microsystems, Inc.·Product code NJT·July 26, 2011

    Radionuclide Radiation Therapy System Product The product is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IWB·April 19, 2016

    Autosampler, Models: SIL-20ACXR CL, SIL-20ACHT CL, SIL-30AC CL

    FDA Recall
    Open, Classified ·Product code KIE·October 9, 2024

    Leksell Gamma Knife Perfexion, Product Number: 715000. Radionuclide radiation therapy system. Elekta, Inc. Norcross, GA. Intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IWB·November 6, 2009

    Leica Bond Ready-to-Use Primary Antibody CDX2 (AMT28); an in vitro diagnostic immunohistochemistry primary antibody kit; Catalog No. PA0535; Leica Biosystems Newcastle Ltd., Balliol Business Park West, Benton Lane, Newcastle Upon Tyne NE12 8EW, United Kingdom. The CDX2 (AMT28) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CDX2 protein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated Bond system. The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.

    FDA Recall
    Terminated ·Leica Microsystems, Inc.·Product code NJT·July 26, 2011

    Leksell Gamma Knife Perfexion, Radionuclide radiation therapy system. Article Number 715000, Elekta, Inc. Norcross, GA 30092. Teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sized os a few millimeters to several centimeters.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IWB·November 9, 2008

    Leica Bond Ready-to-Use Primary Antibody Epithelial Membrane Antigen (GP1.4); an in vitro diagnostic immunohistochemistry primary antibody kit; Catalog No. PA0035; Leica Biosystems Newcastle Ltd., Balliol Business Park West, Benton Lane, Newcastle Upon Tyne NE12 8EW, United Kingdom. Epithelial Membrane Antigen (GP1.4) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human epithelial membrane antigen in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated Bond-max system. The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.

    FDA Recall
    Terminated ·Leica Microsystems, Inc.·Product code NJT·July 26, 2011

    Bond Polymer Refine Detection Kit; an in vitro diagnostic immunohistochemistry reagent kit; Catalog No. DS9800; Leica Biosystems Newcastle Ltd., Balliol Business Park West, Benton Lane, Newcastle Upon Tyne NE12 8EW, United Kingdom. Intended for immunohistochemistry on paraffin-embedded tissue sections.

    FDA Recall
    Terminated ·Leica Microsystems, Inc.·Product code NJT·November 16, 2010