BEUDAMED
    15 results · 21ms · Sources: EU EUDAMED, US FDA

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    InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). Product Usage: The InnerCool RTx device is a thermal regulating system intended to induce, maintain and reverse mild hypothermia, to achieve and/or maintain normothermia, and for use in fever reduction. K080908

    FDA Enforcement
    Class II ·Terminated·Philips Healthcare·February 5, 2014

    InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). Product Usage: The InnerCool RTx device is a thermal regulating system intended to induce, maintain and reverse mild hypothermia, to achieve and/or maintain normothermia, and for use in fever reduction. K080908

    FDA Recall
    Terminated ·Philips Healthcare·Product code NCX·January 13, 2014

    BIOMET 3i, PROVIDE IMPRESSION COPING KITS, Catalog # PRK484, PRK485, PRK654, and PRK655 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.

    FDA Enforcement
    Class II ·Terminated·Biomet 3i, LLC·January 13, 2016

    DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 28 cm Straight Basic Kit, Catalog Number/REF 10302804, 510 (k) 080400, Sterile --- Manufactured in USA by AngioDynamics, Inc. 603 Queensbury Avenue, Queensbury, NY 12804

    FDA Recall
    Terminated ·Angiodynamics, Inc.·Product code MSD·January 8, 2010

    DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 40 cm Straight Basic Kit, Catalog Number/REF 10302807, 510 (k) 080400, Sterile --- Manufactured in USA by AngioDynamics, Inc. 603 Queensbury Avenue, Queensbury, NY 12804

    FDA Recall
    Terminated ·Angiodynamics, Inc.·Product code MSD·January 8, 2010

    DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 24 cm Straight Basic Kit, Catalog Number/REF 10302803, 510 (k) 080400, Sterile --- Manufactured in USA by AngioDynamics, Inc. 603 Queensbury Avenue, Queensbury, NY 12804

    FDA Recall
    Terminated ·Angiodynamics, Inc.·Product code MSD·January 8, 2010

    DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 22 cm Straight Basic Kit, Catalog Number/REF 10302802, 510 (k) 080400, Sterile --- Manufactured in USA by AngioDynamics, Inc. 603 Queensbury Avenue, Queensbury, NY 12804

    FDA Recall
    Terminated ·Angiodynamics, Inc.·Product code MSD·January 8, 2010

    DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 32 cm Straight Basic Kit, Catalog Number/REF 10302805, 510 (k) 080400, Sterile --- Manufactured in USA by AngioDynamics, Inc. 603 Queensbury Avenue, Queensbury, NY 12804

    FDA Recall
    Terminated ·Angiodynamics, Inc.·Product code MSD·January 8, 2010

    DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 36 cm Straight Basic Kit, Catalog Number/REF 10302806, 510 (k) 080400, Sterile --- Manufactured in USA by AngioDynamics, Inc. 603 Queensbury Avenue, Queensbury, NY 12804

    FDA Recall
    Terminated ·Angiodynamics, Inc.·Product code MSD·January 8, 2010

    DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 55 cm Straight Basic Kit, Catalog Number/REF 10302809, 510 (k) 080400, Sterile --- Manufactured in USA by AngioDynamics, Inc. 603 Queensbury Avenue, Queensbury, NY 12804

    FDA Recall
    Terminated ·Angiodynamics, Inc.·Product code MSD·January 8, 2010

    DURAMAX (TM) Hemodialysis Catheters, Stack Tip 28 cm Pre-Curve Basic Kit, Catalog Number/REF 10302813, 510 (k) 080400, Sterile --- Manufactured in USA by AngioDynamics, Inc. 603 Queensbury Avenue, Queensbury, NY 12804

    FDA Recall
    Terminated ·Angiodynamics, Inc.·Product code MSD·January 8, 2010

    DURAMAX (TM) Hemodialysis Catheters, Stack Tip 32 cm Pre-Curve Basic Kit, Catalog Number/REF 10302814, 510 (k) 080400, Sterile --- Manufactured in USA by AngioDynamics, Inc. 603 Queensbury Avenue, Queensbury, NY 12804

    FDA Recall
    Terminated ·Angiodynamics, Inc.·Product code MSD·January 8, 2010

    DURAMAX (TM) Hemodialysis Catheters, Stack Tip 24 cm Pre-Curve Basic Kit, Catalog Number/REF 10302812, 510 (k) 080400, Sterile --- Manufactured in USA by AngioDynamics, Inc. 603 Queensbury Avenue, Queensbury, NY 12804

    FDA Recall
    Terminated ·Angiodynamics, Inc.·Product code MSD·January 8, 2010

    DURAMAX (TM) Hemodialysis Catheters, Stack Tip 36 cm Pre-Curve Basic Kit, Catalog Number/REF 10302815, 510 (k) 080400, Sterile --- Manufactured in USA by AngioDynamics, Inc. 603 Queensbury Avenue, Queensbury, NY 12804

    FDA Recall
    Terminated ·Angiodynamics, Inc.·Product code MSD·January 8, 2010

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014