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

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    GOAT ANTI-HUMAN IGM

    FDA 510(k)
    FDA Class 2 ·Immunology

    THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES

    FDA 510(k)
    FDA Class 2 ·Hematology

    KIMGUARD ONE-STEP STERILIZATION WRAP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HEARTSINE SAMARITAN 300P AND PAD PAK

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·February 12, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 23, 2012

    FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code NBW·August 22, 2007

    GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·January 19, 2022

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

    PROPONENT DR SL (Model L201)

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

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024