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

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    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112885·CORNEAL TREPHINE BLADE6.75MM

    Sapphire II Pro

    FDA UDI
    OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955942372·Balloon Dilatation Catheter

    Sapphire NC Plus

    FDA UDI
    OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955916793·Percutaneous Transluminal Coronary Angioplasty ...

    SAFETOUCH PSV WINGED INFUSION SET WITH/WITHOUT FILTER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFOTAXIME 0.5-64 UG/ML

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MECTALIF ANT - LAG

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code OVD·April 12, 2024

    METRIX AIR

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·December 29, 2016

    AFFINITY 3

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code HDD·November 4, 2008

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·September 2, 2011

    PINNACLE MTL INS NEUT40IDX58OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·July 17, 2013

    10.2MM CANNULATED DRILL BIT LENGTH 251MM

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HWE·February 16, 2020

    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·February 26, 2020