BEUDAMED
    14 results · 22ms · Sources: EU EUDAMED, US FDA

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    2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a pouch, 5 pouches per carton, lot # MBZ140, MBZL450, MBZV930 MBZZ490 Product Usage: The 2F and 3F Vascu-Sheath Tearaway Introducer is intended for percutaneous venous access by modified Seldinger Technique in neonates, infants and children.

    FDA Enforcement
    Class II ·Terminated·Medical Components, Inc dba MedComp·June 15, 2016

    Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a pouch, 5 pouches per carton, lot # MBZ140, MBZL450, MBZV930 MBZZ490 Product Usage: The 2F and 3F Vascu-Sheath Tearaway Introducer is intended for percutaneous venous access by modified Seldinger Technique in neonates, infants and children.

    FDA Recall
    Terminated ·Medical Components, Inc dba MedComp·Product code DYB·May 5, 2016

    VITALOGRAPH HAND HELD SPIROMETER, MODEL 2120

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091C

    FDA 510(k)
    FDA Class 2 ·Hematology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 28, 2025

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 3, 2024

    CELL-DYN SAPPHIRE SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code GKZ·May 15, 2023

    CELL-DYN SAPPHIRE ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·October 12, 2017

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code NIQ·May 24, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 30, 2014

    EXCEL 1064NM ND: YAG LASER

    FDA Adverse Event
    Other ·CUTERA·Product code GEX·June 2, 2011

    CANNULATED CRUCIFORM SCREWDRIVER

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HXX·February 6, 2019

    Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

    FDA Enforcement
    Class II ·Terminated·Senseonics, Inc.·November 6, 2019