BEUDAMED
    7 results · 26ms · Sources: EU EUDAMED, US FDA

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    IPL Hair Removal Device, model: AI01, AI06, AI08, AI16, AI17

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

    CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GUIDEMIA

    FDA 510(k)
    FDA Class 2 ·Radiology

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·August 17, 2011

    ECHELON 45 ENDOPATH STAPLER

    FDA Adverse Event
    Death ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·November 5, 2008

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORP.·Product code DSQ·July 9, 2013

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty

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