BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    GENIE' SINGLE CEILING AND DOUBLE CEILING

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

    PATHFINDER(TM) SPECIMEN COLLECTION KIT

    FDA 510(k)
    FDA Class 1 ·Microbiology

    INTRALASE FUSION LASER

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

    C-QUR

    FDA Adverse Event
    Injury ·ATRIUM MEDICAL CORP·Product code FTL·January 2, 2013

    BIPOL LEAD MODEL 300

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·December 21, 2010

    SERVO-S

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·May 8, 2014

    Stryker PCA 10 Degree Hooded Acetabular Insert ID 22mm, Part of the Howmedica PCA Total Hip System intended for use during total hip arthroplasty. The acetabular insert is used in conjunction with PCA Acetabular Shells and Femoral Heads to restore hip joint biomechanics.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·November 25, 2015

    Stryker PCA 10 Degree Hooded Acetabular Insert ID 22mm, Part of the Howmedica PCA Total Hip System intended for use during total hip arthroplasty. The acetabular insert is used in conjunction with PCA Acetabular Shells and Femoral Heads to restore hip joint biomechanics.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code JDI·October 15, 2015

    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