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

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    Cryocheck Chromogenic Factor VIII

    FDA 510(k)
    FDA Class 2 ·Hematology

    Orthos

    FDA UDI
    ORMCO CORPORATION·00889989030426·ORTHOS CM NITI ARCH18 DIA UPSM PK10

    SOLARC / SOLRX E-SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    INNOVATIVE MED MULTI WAVE LIGHT THERAPY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·September 14, 2022

    INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FTR·January 3, 2025

    LEAD MODEL 302

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·October 7, 2008

    FLEXCATH STEERABLE SHEATH

    FDA Adverse Event
    Malfunction ·MEDTRONIC CRYOCATH LP·Product code DRA·August 5, 2011

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·June 27, 2013

    Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

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