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

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    DUPONT DIMENSION(R) GENTAMICIN(GENT) METHOD

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    INTRAVASCULAR IMAGING SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MODEL 2121-21, TMJ SURFACE COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    Part #313.221, 1.5mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341033, 4589566, 4703774, 4363781, 4589567, 4793575, 4904305, 4427700,4589568, 4830581, 4532370, 4673943, 4871657, mfg. 2/12/2002-5/23/2005 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·July 20, 2016

    MENTOR SMOOTH ROUND SPECTRUM

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·March 28, 2018

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·January 9, 2013

    INSIGNIA

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 1, 2014

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC. USA·Product code LFR·October 26, 2007

    Part #313.221, 1.5mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341033, 4589566, 4703774, 4363781, 4589567, 4793575, 4904305, 4427700,4589568, 4830581, 4532370, 4673943, 4871657, mfg. 2/12/2002-5/23/2005 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.

    FDA Recall
    Terminated ·Synthes (USA) Products LLC·Product code HWE·May 31, 2016