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

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    NMR LIPOPROFILE (R) TEST AND NMR PROFILER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    A Series

    FDA UDI
    Respironics, Inc.·00606959032088·A Series Heated Humidifier, USA

    Portex

    FDA UDI
    ICU MEDICAL, INC.·00351688030408·

    MicroSelectron Digital

    FDA UDI
    Nucletron B.V.·08717213033498·Coupling Treatment Tube for 4F Flexibles (16)

    Surgical Instrument

    FDA UDI
    Jeil Medical Corporation·08800089448913·

    TALOS® HA PEEK IBF

    FDA UDI
    MEDITECH SPINE, LLC·B167321115160·

    NITINOL TC ELECTRODE

    FDA Adverse Event
    Malfunction ·COSMAN MEDICAL·Product code LGW·April 4, 2017

    INFANT FLOW SYSTEM, MODEL M672P

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CONNEX VITAL SIGNS MONITOR 6000 SERIES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NITINOL TC ELECTRODE

    FDA Adverse Event
    Malfunction ·COSMAN MEDICAL·Product code GXI·April 4, 2017

    NITINOL TC ELECTRODE

    FDA Adverse Event
    Malfunction ·COSMAN MEDICAL·Product code GXI·April 19, 2017

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 13, 2024

    Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code CBK·April 18, 2022

    NITINOL TC ELECTRODE

    FDA Adverse Event
    Malfunction ·COSMAN MEDICAL·Product code GXI·June 14, 2017

    VERSAFITCUP DM ACETABULAR SHELL

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL, SA·Product code MEH·December 14, 2012

    U-BLADE SET, TI GAMMA3 10.5X90MM

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·November 30, 2012

    Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)

    FDA Enforcement
    Class I ·Ongoing·GE Healthcare, LLC·June 15, 2022

    NITINOL TC ELECTRODE

    FDA Adverse Event
    Malfunction ·COSMAN MEDICAL·Product code GXI·June 14, 2017

    TC ELECTRODE

    FDA Adverse Event
    Malfunction ·COSMAN MEDICAL·Product code GXI·April 18, 2018

    NITINOL TC ELECTRODE

    FDA Adverse Event
    Malfunction ·COSMAN MEDICAL·Product code GXI·April 5, 2017