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

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    M-Y Sheath

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    POWDER-FREE NITRILE GLOVES, BLACK

    FDA 510(k)
    FDA Class 1 ·General Hospital

    PRODRIVE LINE OF DENTAL HANDPIECES

    FDA 510(k)
    FDA Class 1 ·Dental

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 21, 2025

    GORILLA/BABY GORILLA PLATING SYSTEM

    FDA Adverse Event
    Injury ·PARAGON 28, INC·Product code HRS·September 17, 2020

    UNKNOWN DEPUY FEMORAL COMPONENT

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code HSA·October 3, 2008

    CUSTOM COMBI SET

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FJK·June 21, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·July 28, 2011

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

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