BEUDAMED
    24 results · 38ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Terminated ×

    Vital-Port Vascular Access System, Subcutaneous, implanted, intravascular infusion port and catheter, IP, IP-S, Product usage: The devices are intended for use in patient therapy requiring long-term vascular access for infusion therapy and/or blood sampling.

    FDA Enforcement
    Class II ·Terminated·Cook Vascular Inc.·April 4, 2018

    Flexipet Manipulation Pipette 300 micron. The product is boxed with 1 vial of 10 pipettes. This product is used for the intracytoplasmic single sperm injection of oocytes.

    FDA Recall
    Terminated ·Cook Vascular Inc.·Product code MQH·December 17, 2007

    Flexipet Denuding pipette 130 micron. The product is boxed with 5 vials of 10. The device is used for the intracytoplasmic single sperm injection of oocytes.

    FDA Recall
    Terminated ·Cook Vascular Inc.·Product code MQH·March 2, 2008

    Vital-Port Vascular Access System, Subcutaneous, implanted, intravascular infusion port and catheter, IP, IP-S, Product usage: The devices are intended for use in patient therapy requiring long-term vascular access for infusion therapy and/or blood sampling.

    FDA Recall
    Terminated ·Cook Vascular Inc.·Product code LJT·November 28, 2017

    Vital Port Vascular Access System Polysulfone Petite with detached 1.0mm catheter

    FDA Recall
    Terminated ·Cook Vascular Inc.·Product code LJT·April 24, 2008

    Vital Port Vascular Access System Polysulfone Petite with detached 0.9mm catheter

    FDA Recall
    Terminated ·Cook Vascular Inc.·Product code LJT·April 24, 2008

    Flexipet Manipulation pipette 300 micron. The device is used for the intracytoplasmic single sperm injection of oocytes.

    FDA Recall
    Terminated ·Cook Vascular Inc.·Product code MQH·March 2, 2008

    Beacon Tip Royal Flush Plus High-Flow Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters and wire guides should be employed.

    FDA Recall
    Terminated ·Cook Inc.·Product code DQO·April 15, 2016

    Beacon Tip Torcon NB Advantage Catheter Catheter, Intravascular, Diagnostic

    FDA Recall
    Terminated ·Cook Inc.·Product code DQO·April 15, 2016

    Beacon Tip Centimeter Sizing Catheter Beacon Tip White Vessel Sizing Catheter Beacon Tip Vessel Sizing Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters and wire guides should be employed.

    FDA Recall
    Terminated ·Cook Inc.·Product code DQO·April 15, 2016

    Slip-Cath Beacon Tip Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques.

    FDA Recall
    Terminated ·Cook Inc.·Product code DQO·April 15, 2016

    Neff DAgostino Percutaneous Access Set Accessories, Catheter Intended for single-puncture percutaneous access to facilitate placement of an .038 inch (0.97 mm) diameter working wire guide for interventional radiology procedures

    FDA Recall
    Terminated ·Cook Inc.·Product code KGZ·April 15, 2016

    Aprima Access Nonvascular Introducer Set Accessories, Catheter Intended for single-puncture percutaneous access to facilitate placement of an .038 inch (0.97 mm) diameter working wire guide for interventional radiology procedures

    FDA Recall
    Terminated ·Cook Inc.·Product code KGZ·April 15, 2016

    Transluminal Biliary Biopsy Forceps Set Forceps, Biopsy, Non-Electric Intended for access to and biopsy of tissue within the biliary ductal system

    FDA Recall
    Terminated ·Cook Inc.·Product code FCL·April 15, 2016

    White Lumax Guiding Coaxial Catheter Catheter, Percutaneous Intended for the delivery of angioplasty balloons and other types of interventional devices.

    FDA Recall
    Terminated ·Cook Inc.·Product code DQY·April 15, 2016

    Shuttle Select Slip-Cath Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques

    FDA Recall
    Terminated ·Cook Inc.·Product code DQO·April 15, 2016

    Haskal Transjugular Intrahepatic Portal Access Set Introducer, catheter Intended for transjugular liver access in diagnostic and interventional procedures.

    FDA Recall
    Terminated ·Cook Inc.·Product code DYB·April 15, 2016

    Liver Access and Biopsy Needle Set Biopsy needle kit Intended for use in obtaining liver histology samples via a jugular vein approach.

    FDA Recall
    Terminated ·Cook Inc.·Product code FCG·April 15, 2016

    Selective Salpingography Catheter with Beacon Tip Cannula, Manipulator/ Injector, Uterine Used for injection of contrast medium into the fallopian tube(s) for selective salpingography.

    FDA Recall
    Terminated ·Cook Inc.·Product code MOV·April 15, 2016

    FluoroSet Radiographic Tubal Assessment Set Cannula, Manipulator/ Injector, Uterine Used for instillation of contrast media into the uterine cavity for radiographic evaluation of the uterine cavity and for injection of appropriate contrast media into the fallopian tubes for evaluation of tubal patency.

    FDA Recall
    Terminated ·Cook Inc.·Product code LFK·April 15, 2016