BEUDAMED
    13 results · 27ms · Sources: EU EUDAMED, US FDA

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    CONVERTA-LITTER

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556704018·GC Initial™ AL Enamel Occlusal EO-15, 20g

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228740601·GC Initial™ Ti Dentin DC1, 20g

    PROTECT DROPS/SAME AS K874070

    FDA 510(k)
    FDA Class 2 ·Dental

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867523852·Spine Compression Screw, 4.0x60mm

    ISOSTATION ANKLE/SUBTALAR MACHINE A-100

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    RELIANCE OPHTHALMIC SLIT LAMP R-083

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SCREW, CANNULATED

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code HWC·March 30, 2018

    MODULAR FEMORAL STEM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·May 13, 2020

    MEDTRONIC PACEMAKER

    FDA Adverse Event
    Malfunction ·MEDTRONIC·Product code DTE·June 11, 2014

    PUMP MMT-522LNAL PRDGM INS CL EN ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code MDS·October 15, 2010

    CLEARLINK SYSTEM CONTINU-FLO4 WAY STOPCOCK EXT SET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - AIBONITO·Product code FMG·December 14, 2012

    Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·July 22, 2015