BEUDAMED
    10 results · 21ms · Sources: EU EUDAMED, US FDA

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    SLIP-CATH BEACON TIP CATHETER MODEL SCBR (PRODUCT PREFIX), SHUTTLE SELECT SLIP-CATH CATHETER MODEL SCBR (PRODUCT PREFIX)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

    FDA Adverse Event
    Injury ·COOK INC·Product code DQO·August 10, 2023

    MRSA/SA ELITE MGB

    FDA 510(k)
    FDA Class 2 ·Microbiology

    OSTEOPHIL BETA-TCP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CODA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQY·October 23, 2017

    ACTIVA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·May 21, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 26, 2014

    COZMO INSULIN PUMP

    FDA Adverse Event
    Injury ·SMITHS MEDICAL MD (FORMERLY DELTEC, INC)·Product code LZG·June 9, 2011

    CODA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQY·September 10, 2019

    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