BEUDAMED
    14 results · 23ms · Sources: EU EUDAMED, US FDA

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    CHRONOCOR IV MODEL 250

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VITROS

    FDA UDI
    ORTHO CLINICAL DIAGNOSTICS·10758750002337·VITROS Immunodiagnostic Products Total B HCG II...

    ACUMED

    FDA UDI
    Acumed LLC·10806378101182·2.0mm VA Drill Guide

    RAYDOSE

    FDA 510(k)
    FDA Class 2 ·Radiology

    KURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103-1006 170

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·May 22, 2018

    ROTATING MULTIPLE CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·May 9, 2014

    COULTER® LH 780 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·October 23, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 6, 2007

    BD¿ SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·November 14, 2018

    BD¿ IV SET SN404 W/O BP Y-CONN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FOZ·August 9, 2018

    EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.

    FDA Enforcement
    Class II ·Terminated·Dako North America Inc.·November 11, 2015

    1) VITROS¿ Immunodiagnostic Products Total Beta-hCG II Reagent Pack (Unique Device Identifier No. 10758750002320, 20758750002327) and the 2)VITROS¿ Immunodiagnostic Products Total Beta-hCG II Calibrators (Unique Device Identifier No. 10758750002337, 20758750002334); For quantitative measurement of human chorionic gonadotropin (hCG) and its beta subunit in human serum and plasma.

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics·June 1, 2016

    GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·January 19, 2022