BEUDAMED
    23 results · 23ms · Sources: EU EUDAMED, US FDA

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    FDA 510(k)
    FDA Class 2 ·General Hospital

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704283174·DEAVER RETRACTOR HOLLOW 3" X 12"

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111129612·SKLHN STEVENS SCISS STR BL 4.5

    GENESIS DM MODEL: 6053000A1

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    WINNER SELF SEAL STERILIZATION POUCH

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 20, 2020

    BLOOD FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC., USA·Product code NBW·September 6, 2007

    840 VENTILATOR

    FDA Adverse Event
    Injury ·COVIDIEN·Product code CBK·June 20, 2017

    840 VENTILATOR

    FDA Adverse Event
    Injury ·COVIDIEN·Product code CBK·August 1, 2017

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code CBK·July 25, 2017

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code CBK·August 17, 2017

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code CBK·March 21, 2017

    LEAD MODEL 302

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·October 8, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2013

    ASR UNI FEMORAL IMPL SIZE 46

    FDA Adverse Event
    Injury ·DEPUY INTL, LTD.·Product code KWA·June 30, 2011

    BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.

    FDA Enforcement
    Class II ·Ongoing·Smith & Nephew Inc.·December 11, 2024

    CONTOUR® NEXT

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code JJX·September 4, 2025

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    840 VENTILATOR

    FDA Adverse Event
    Injury ·COVIDIEN·Product code CBK·June 26, 2017

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025