BEUDAMED
    22 results · 24ms · Sources: EU EUDAMED, US FDA

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    GE DATEX-OHMEDA AISYS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SOFTIQUE, MODEL GI 11001

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    CARDIONET AMBULATORY ECG MONITOR, MODEL CN1000A

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LINEAR ST

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 27, 2022

    FISHER & PAYKEL HEALTHCARE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 11, 2025

    FISHER & PAYKEL HEALTHCARE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·March 3, 2025

    FISHER & PAYKEL HEALTHCARE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 23, 2025

    FISHER & PAYKEL HEALTHCARE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·November 27, 2024

    880 HUMIDIFICATION SYSTEM

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·March 31, 2010

    ASR ACETABULAR CUP 52

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·April 23, 2013

    ACRYSOF

    FDA Adverse Event
    Malfunction ·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·April 13, 2011

    NC MERLIN PTCA CATHETER (OTW)

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code LOX·July 1, 2008

    880 HUMIDIFICATION SYSTEM

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD.·Product code BTT·February 15, 2010

    RESPIRATORY HUMIDIFIER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·May 12, 2024

    RESPIRATORY HUMIDIFIER

    FDA Adverse Event
    Injury ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·July 4, 2024

    OLYMPUS ESG-100, 100...120 V~,

    FDA Adverse Event
    Injury ·OLYMPUS WINTER & IBE GMBH·Product code GEI·September 27, 2022

    880 HUMIDIFICATION SYSTEM

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·April 15, 2010

    FISHER & PAYKEL HEALTHCARE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·December 6, 2023

    KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE

    FDA 510(k)
    FDA Class 2 ·Neurology

    Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-23, c) 44, 47, 50, 53 head, Large, Item Number 314-02-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-25; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024