BEUDAMED
    9 results · 25ms · Sources: EU EUDAMED, US FDA

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    POLYCENTRIC TOTAL KNEE METAL TIBIAL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACUPUNCTURE NEEDLES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    RAPIDPoint 500e Blood Gas System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    JUGGERKNOT SOFT ANCHORS JUGGERKNOT MINI

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code MBI·March 9, 2018

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS·Product code JAA·January 13, 2014

    PARADYM

    FDA Adverse Event
    Injury ·SORIN C.R.M., S.R.L.·Product code MRM·October 12, 2012

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·May 22, 2015

    Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA6424, AA6C18, AA6C20, AA6C22, and AA6C24.

    FDA Enforcement
    Class II ·Ongoing·Coloplast Manufacturing US, LLC·January 22, 2025

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018