BEUDAMED
    11 results · 35ms · Sources: EU EUDAMED, US FDA

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    Blood Pressure Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BEACON TIP TORCON NB ADVANTAGE CATHETER, TORCON NB ADVANTAGE CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    G7 DUAL MOBILITY LINER 36MM B

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code LZO·February 13, 2020

    UNKOWN G7 CUP

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code JDI·February 13, 2020

    LINOX SD 65/18

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code LWS·July 22, 2011

    FLO-GARD 6301 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FRN·November 18, 2008

    DAILY ACTIVITY ASSIST DEVICES

    FDA Adverse Event
    LERADO GLOBAL·Product code ILS·July 18, 2013

    BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code DQO·October 10, 2017

    DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

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

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025