BEUDAMED
    8 results · 20ms · Sources: EU EUDAMED, US FDA

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    CHOLESTEROL KIT, HDL-DS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    HardyCHROM CRE

    FDA 510(k)
    FDA Class 2 ·Microbiology

    NAVISCAN PEMFLEX SOLO II HIGH RESOLUTION PET SCANNER

    FDA 510(k)
    FDA Class 2 ·Radiology

    INCEPTA

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·May 5, 2014

    SPRINT QUATTRO SECURE S

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 15, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·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