BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    CEDIA(R) GENTAMICIN ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    NIPRO SAFE TOUCH HUBER INFUSION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MODIFICATION TO M2376A DEVICELINK SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    UNKNOWN

    FDA Adverse Event
    Injury ·COOK ENDOSCOPY·Product code KGE·April 4, 2017

    XPRT

    FDA Adverse Event
    Malfunction ·GAYMAR INDUSTRIES, INC.·Product code FNM·November 24, 2010

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 3, 2014

    ACCU-CHEK SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·December 21, 2012

    BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017