BEUDAMED
    11 results · 28ms · Sources: EU EUDAMED, US FDA

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    CPR MICROSHIELD II

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Optina-4C (MHRC-C1N)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MODIFICATION TO ACCUFUSER, ACCUFUSER PLUS STANDARD PROCEDURE KIT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES·Product code LZG·June 9, 2014

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·February 8, 2013

    COGNIS

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·January 6, 2011

    OSS 3CM ELLIP DIAPHYSEAL SEG

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·September 9, 2019

    OSS POROUS IM STEM 15.5 X 150

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·September 9, 2019

    OSS 3CM ELLIP DIAPHYSEAL SEG

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·September 10, 2019

    OSS POROUS IM STEM 15.5 X 150

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·September 10, 2019

    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