BEUDAMED
    8 results · 17ms · Sources: EU EUDAMED, US FDA

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    CHOLESTEROL REAGENT, AUTOMATED ENZYMATIC

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Zimmer Biomet Universal Navigation System

    FDA 510(k)
    FDA Class 2 ·Neurology

    SPACELABS ELANCE VITAL SIGNS MONITORING SYSTEM AND CENTRAL MONITOR SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code FYD·May 5, 2014

    CARELINK

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code KRG·October 15, 2012

    FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code NBW·August 23, 2007

    PROPONENT DR SL (Model L201)

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

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty

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