BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    GRAM - & GRAM + MIC/COMBO & BREAKPOINT/COMBO PANEL

    FDA 510(k)
    FDA Class 2 ·Microbiology

    PENNINE NELATON CATHETERS SIZES 5,6,8,10,12,14,16,

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ALDOSTERONE DIRECT RIA KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SPRINT FIDELIS

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code LWS·February 9, 2016

    SPRINT FIDELIS

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code LWS·December 4, 2015

    COAGUCHEK ® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·June 16, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code NBW·October 19, 2010

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 16, 2012

    BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026