BEUDAMED
    36 results · 35ms · Sources: EU EUDAMED, US FDA

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    ACCUVIX V20 DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    Onik-Cohen

    FDA UDI
    COOK INCORPORATED·00827002161429·Onik-Cohen Percutaneous Access/Catheter Set

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810014607573·SKYTRON 6700, 6701 4.25" SOFTCARE PLUS

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702399363·ELVAREX 2/KNEE HIGH/CLOSED TOE-ELEPHANTIASIS-VE...

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702367416·ELVAREX 3/KNEE HIGH/CLOSED TOE-ELEPHANTIASIS-VE...

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345023857·BAYONETTED OSTEOTOME - 1/4"

    VERSYO.COM

    FDA 510(k)
    FDA Class 2 ·Dental

    OPTAX SYSTEM

    FDA 510(k)
    FDA Unclassified ·Unknown

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·June 13, 2019

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·June 13, 2019

    EMAX2PLUS

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·October 1, 2015

    EMAX 2 MOTOR

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·June 6, 2015

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·April 12, 2013

    PLASTIC CIRCULAR PLATE

    FDA Adverse Event
    Injury ·TRIMED, INC.·Product code HRS·September 5, 2014

    AU681-02E CHEMISTRY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER MISHIMA K.K.·Product code JJE·May 6, 2011

    FUSION TITAN DILATION BALLOON

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FGE·May 4, 2018

    SYSTEM CONSOLE

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·March 20, 2017

    iChem VELOCITY Automated Urine Chemistry, Catalog No. 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190, 800-7713, 800-7714, 800-7719, 800-7720 iChem VELOCITY Urine Chemistry Strips, Catalog No. 800-7212 & 800-7212-001

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·March 16, 2016

    iChemVELOCITY Automated Urine Chemistry Catalog No. 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190, 800-7713,800-7714, 800-7719, 800-7720. An in vitro diagnostic device used to automate the urine chemistry analysis profile using iChemVELOCITY Urine Chemistry Strips.

    FDA Enforcement
    Class II ·Terminated·Iris Diagnostics·September 2, 2015

    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