BEUDAMED
    9 results · 23ms · Sources: EU EUDAMED, US FDA

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    FDA 510(k)
    FDA Class 2 ·General Hospital

    TAIWAN KING STRONG POWERED WHEELCHAIR, TP 02

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    INFRARED EAR THERMOMETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PUMP IN STYLE

    FDA Adverse Event
    Injury ·MEDELA, INC.·Product code HGX·May 24, 2013

    EASYTRAK 2

    FDA Adverse Event
    Death ·CPI - DEL CARIBE·Product code OJX·June 18, 2011

    LADARVISION 4000

    FDA Adverse Event
    Malfunction ·ALCON - ORLANDO TECHNOLOGY CENTER·Product code LZS·August 22, 2008

    Achieva 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 2023

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty

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

    Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026