BEUDAMED
    26 results · 21ms · Sources: EU EUDAMED, US FDA

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    FiteBac CC OrthoSeal

    FDA 510(k)
    FDA Class 2 ·Dental

    Trivex System

    FDA UDI
    Lemaitre Vascular, Inc.·00840663106738·Trivex System Replacement Lamp

    NA

    FDA UDI
    ZOE MEDICAL INCORPORATED·00851920007286·Temperature Adapter Cable (Zoe to YSI-400 1/4 i...

    Resolve® Ceramic

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K210151111·Resolve® Ceramic R018 UL 5-5 CS BC HK

    TiWAVE L Lumbar Cage System

    FDA UDI
    Kalitec Direct LLC·B07323K0101150·Distractor, Smooth Paddle, Lordotic, 15mm

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0101150·Distractor, Smooth Paddle, 15mm

    Resolve® Ceramic

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K210151811·Resolve® Ceramic M018 UL 5-5 CS BC HK

    Resolve® Ceramic

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K210151121·Resolve® Ceramic R018 UL 5-5 CS HK/MBT 4-5

    VIDAS D-DIMER EXCLUSION II 60T

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code DAP·July 1, 2020

    REFLEX ANTERIOR CERVICAL PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ORTHOSIZE

    FDA 510(k)
    FDA Class 2 ·Radiology

    Widex

    FDA UDI
    Widex A/S·05706069914542·WIDEX MOMENT MRB2D (Chestnut brown ) 110, Telec...

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 19, 2012

    OT VERIO2 METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 16, 2016

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·October 17, 2008

    COULTER LH 500 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·August 5, 2011

    FLEXTEND II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·July 8, 2013

    OPTIFLUX 160NRE DIALYZER FINISHED ASSY.

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FJI·June 6, 2013

    SYNVISC (HYLAN G-F 20) INJECTION

    FDA Adverse Event
    Other ·GENZYME CORPORATION·Product code MOZ·May 9, 2008

    SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C

    FDA Enforcement
    Class II ·Ongoing·FUJIFILM Healthcare Americas Corporation·September 21, 2022