BEUDAMED
    22 results · 20ms · Sources: EU EUDAMED, US FDA

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    E-Z WIDER BARIATRIC CHAIR BED; Single Motion Expandable Width Technology

    FDA Enforcement
    Class II ·Terminated·Kreg Medical Inc.·June 12, 2013

    Easypump LT 100-200 Elastomeric Infusion Pump (100 ml x 0.5 ml/hr) Part number: 5001120

    FDA Recall
    Terminated ·I-Flow Corporation·Product code MEB·August 23, 2003

    Medtronic SIGMA 100/200/300 Series IPGs, Dual Chamber Pacemaker, models SD203 and SD303.

    FDA Recall
    Terminated ·Medtronic Inc. Cardiac Rhythm Disease Managment·Product code DXY·May 18, 2009

    Medtronic SIGMA 100/200/300 Series IPGs, Single Chamber Pacemaker; models SS103, SS106, SS203, and SS303.

    FDA Recall
    Terminated ·Medtronic Inc. Cardiac Rhythm Disease Managment·Product code DXY·May 18, 2009

    Medtronic SIGMA 100/200/300 Series IPGs, Single Chamber Pacemaker, model SVVI103, for ventricular use only.

    FDA Recall
    Terminated ·Medtronic Inc. Cardiac Rhythm Disease Managment·Product code DXY·May 18, 2009

    Trilogy 100, 200 and 202 Ventilators The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation.

    FDA Recall
    Terminated ·Respironics, Inc.·Product code CBK·October 11, 2011

    Medtronic SIGMA 100/200/300 Series IPGs, Single Chamber Rate Responsive Pacemaker; models SR353, SSR203, SSR303, and SSR306.

    FDA Recall
    Terminated ·Medtronic Inc. Cardiac Rhythm Disease Managment·Product code DXY·May 18, 2009

    Medtronic SIGMA 100/200/300 Series IPGs, Dual Chamber Rate Responsive Pacemaker, models DR353, SDR203, SDR303, and SDR306.

    FDA Recall
    Terminated ·Medtronic Inc. Cardiac Rhythm Disease Managment·Product code DXY·May 18, 2009

    Medtronic SIGMA 100/200/300 Series IPGs, Dual Chamber atrial sensing, ventricular sensing and pacing Pacemaker, model SVDD303.

    FDA Recall
    Terminated ·Medtronic Inc. Cardiac Rhythm Disease Managment·Product code DXY·May 18, 2009

    ReadyMed Elastomeric Ambulatory Pump, Model Numbers: R050050, R100100, R100200, R250050, R250100, and R250167. Intended for self-administration of anti-microbial and antiviral agents.

    FDA Recall
    Terminated ·Cardinal Health 303 dba Cardinal Health·Product code FRN·December 19, 2008

    IMRIS T2X Table, Part Numbers: (a) 108000-000 (b) 108000-600 (c) 109682-000 (d) 109682-600

    FDA Recall
    Terminated ·Deerfield Imaging, Inc.·Product code FQO·February 23, 2018

    IMRIS ORT200, Removable Operating Room Table, Part Numbers: (a) 113821-000 (b) 113821-600 (c) 114148-000 (d) 114148-600

    FDA Recall
    Terminated ·Deerfield Imaging, Inc.·Product code FQO·February 23, 2018

    IMRIS ORT100 Table, Part Numbers: (a) 110470-000 (b) 110470-600

    FDA Recall
    Terminated ·Deerfield Imaging, Inc.·Product code FQO·February 23, 2018

    IMRIS ORT300, Removable Operating Room Table, Part Numbers: (a) 114093-000 (b) 114093-600

    FDA Recall
    Terminated ·Deerfield Imaging, Inc.·Product code FQO·February 23, 2018

    xTAG CYP2D6 Kit v3 IVD For use with Luminex 100/200 Instrument Luminex Molecular Diagnostics, Inc. 439 University Ave. Toronto, Ontario Canada Catalog # I030B0373 The xTAG CYP2D6 Kit v3 is a device used to simultaneously detect and identify a panel of nucleotide variants found within the highly polymorphic CYP2D6 gene located on chromosome 22 from genomic DNA extracted from EDTA and citrate anticoagulated whole blood samples.

    FDA Recall
    Terminated ·Luminex Corporation·Product code NTI·May 24, 2011

    Respironics Trilogy 100, 200, and 202 Ventilators The Respironics Trilogy systems provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Trilogy 100 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The devices are intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. They are not intended to be used as a transport ventilator.

    FDA Recall
    Terminated ·Respironics, Inc.·Product code CBK·April 27, 2012

    T3F, Free T3 Assay, REF/Catalog Number LKF31, Siemens Material Number (SMN) 10381626; an IVD Immunoassay kit for use with the IMMULITE/IMMULITE 1000 Analyzers --- Shipping or unit package: 100, 200, 500 and 600 test kits --- Origin: UK Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL55 4EL UK. For the quantitative measurement of Free T3 in serum, as an aid in the clinical assessment of thyroid status.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics·Product code CDP·August 27, 2013

    T3F, Free T3 Assay, REF/Catalog Number LKF31, Siemens Material Number (SMN) 10381626; an IVD Immunoassay kit for use with the IMMULITE/IMMULITE 1000 Analyzers --- Shipping or unit package: 100, 200, 500 and 600 test kits --- Origin: UK Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL55 4EL UK. For the quantitative measurement of Free T3 in serum, as an aid in the clinical assessment of thyroid status.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics·February 5, 2014

    Respironics Trilogy 100, 200, and 202 Ventilators The Respironics Trilogy systems provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Trilogy 100 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The devices are intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. They are not intended to be used as a transport ventilator.

    FDA Enforcement
    Class I ·Terminated·Respironics, Inc.·August 1, 2012

    PSA Assays for use in the IMMULITE/IMMULITE 1000 Systems Analyzers, Catalog Numbers LKPS1, LKPS5 and LKPTS1(D); and in the IMMULITE 2000/2000XPi Systems Analyzers, Catalog Numbers L2KPS2, L2KPS6, L2KPTS2(D) and L2KPTS6(D). IVD Immunoassay kits in the following sizes: 100, 200, 500 and 600 test kits; For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 and the IMMULITE 2000/ 2000 XPi Systems Analyzers. PMA # P930027/ Device Listing # D002374. Product Usage: For the quantitative measurement of prostate-specific antigen (PSA) in human serum, as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (DRE) in men aged 50 years or older. This assay is further indicated as an adjunctive test to aid in the management of prostate cancer patients. For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 and the IMMULITE 2000/ 2000 XPI Systems Analyzers

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics·Product code MFT·June 26, 2013