BEUDAMED
    9 results · 34ms · Sources: EU EUDAMED, US FDA

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    BIODERM PVP FOAM WOUND DRESSING

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Acrometrix BB NAT HIV-1 POS. CTRL

    FDA UDI
    Microgenics Corporation·00884883005891·

    AUTOPULSE RESUSCITATION SYSTEM MODEL100

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Kepler I Cervical Plate System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LOCKING FEMORAL IMPACTOR/EXTRACTOR

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code HWA·December 21, 2010

    SELECTSECURE

    FDA Adverse Event
    Injury ·MPRI·Product code NVN·July 29, 2014

    PCA PLS II

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·November 27, 2012

    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