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

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    SYNTHES SIMPLE SMALL EXTERNAL FIXATOR (SSEF)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TENDERFLOW PERIATRIC ARTERIAL CANNULA

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INDIGO Aspiration System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INDIGO SYSTEM ASPIRATION CATHETER

    FDA Adverse Event
    Injury ·PENUMBRA, INC.·Product code DXE·August 11, 2020

    HEARTSTART ONSITE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 23, 2014

    5.0MM LOCKING SCREW SELF-DRILLING 75MM

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HWC·February 15, 2013

    LAG SCREW DRILL

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS, INC.·Product code LXH·January 11, 2011

    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