BEUDAMED
    17 results · 25ms · Sources: EU EUDAMED, US FDA

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    COULTER LH 750 HEMATOLOGY ANALYZER

    FDA 510(k)
    FDA Class 2 ·Hematology

    MedGyn Pessary Cube w/o drain # 2

    FDA UDI
    MEDGYN PRODUCTS, INC.·M803050057·Cube Pessary is used treat uterine prolapse.

    Altus Spine Pedicle Screw System

    FDA UDI
    Altus Spine, LLC·00843210132051·Head Positioner

    CARDINAL HEALTH

    FDA UDI
    Cardinal Health 200, LLC·10885425945450·LACERATION TRAY

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450335987·

    Cage Holder – Center Shaft

    FDA UDI
    CAPTIVA SPINE, INC.·00850065741864·Cage Holder – Center Shaft

    RADIONICS LUMBOPERITONEAL SHUNT

    FDA 510(k)
    FDA Class 2 ·Neurology

    MODIFICATION TO ARTOSCAN M

    FDA 510(k)
    FDA Class 2 ·Radiology

    MARY HITCHCOCK HANOVER NH 1

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·November 7, 2012

    BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·May 20, 2024

    FINELINE II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·April 10, 2013

    ACTIVA PC

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·March 31, 2011

    CAPSURE SP

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·May 20, 2008

    HZ APPLIER ML 8" CVD

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code GDO·July 29, 2021

    Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm, 23"; Silhouette Paradigm 13mm, 43"; Silhouette Paradigm 13mm, 32"; Silhouette Paradigm 32" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

    FDA Enforcement
    Class II ·Terminated·Unomedical As·November 9, 2016

    Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 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