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

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    MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECT

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    HEARTWAVE ALTERNANS PROCESSING SYSTEM, APS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696

    FDA 510(k)
    FDA Class 2 ·Immunology

    ENDOTAK RELIANCE

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVY·April 8, 2013

    AUTOCAT2 WAVE

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code DSP·May 9, 2008

    EASYTRAK 2

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code OJX·April 6, 2011

    Natus neoBLUE Phototherapy system, Catalogue Part Number: 010066. Top Assembly Part Numbers: 001103, 001314, 002110, 040906, 040904, 040756, 040758, 040658, 040680. Product Usage: Used to provide treatment for neonatal hyperbilirubinemia

    FDA Recall
    Terminated ·Natus Medical Incorporated·Product code LBI·April 11, 2016

    Natus neoBLUE Phototherapy system, Catalogue Part Number: 010066. Top Assembly Part Numbers: 001103, 001314, 002110, 040906, 040904, 040756, 040758, 040658, 040680. Product Usage: Used to provide treatment for neonatal hyperbilirubinemia

    FDA Enforcement
    Class II ·Terminated·Natus Medical Incorporated·June 22, 2016

    Second generation neoBLUE LED Phototherapy Light (neoBLUE 2) sold between 2003 and 2008. Catalog Part Number 010066. Top Assembly Part Numbers: 040906, 040904, 040756, 040758, 040658, 040680. Product Usage: Device is used to provide treatment for neonatal hyperbilirubinemia.

    FDA Recall
    Terminated ·Natus Medical Incorporated·Product code LBI·April 3, 2017

    Second generation neoBLUE LED Phototherapy Light (neoBLUE 2) sold between 2003 and 2008. Catalog Part Number 010066. Top Assembly Part Numbers: 040906, 040904, 040756, 040758, 040658, 040680. Product Usage: Device is used to provide treatment for neonatal hyperbilirubinemia.

    FDA Enforcement
    Class II ·Terminated·Natus Medical Incorporated·May 10, 2017

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM UNCUFFED , Product Code/List Number/Item Code 60P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM UNCUFFED , Product Code/List Number/Item Code 60P030; c) PAED. TRACHEOSTOMY TUBE 3.5MM UNCUFFED , Product Code/List Number/Item Code 60P035; d) PAED. TRACHEOSTOMY TUBE 4.0MM UNCUFFED , Product Code/List Number/Item Code 60P040; e) PAED. TRACHEOSTOMY TUBE 4.5MM UNCUFFED , Product Code/List Number/Item Code 60P045; f) PAED. TRACHEOSTOMY TUBE 5.0MM UNCUFFED , Product Code/List Number/Item Code 60P050; g) PAED. TRACHEOSTOMY TUBE 5.5MM UNCUFFED , Product Code/List Number/Item Code 60P055

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018