BEUDAMED
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    ANTI-HUMAN LAMBDA SERUM

    FDA 510(k)
    FDA Class 2 ·Immunology

    Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1.5T, Panorama 0.6T 1.0T, Magnetic Resonance Imaging Systems intended for clinical/radiologic diagnostic imaging applications.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·October 30, 2013

    MODIFICATION TO ANGIOSCULPT PTA SCORING BALLOON CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Juell 3D Volo Base

    FDA 510(k)
    FDA Class 2 ·Dental

    MIS MODULAR DISTAL CAPTURE

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·April 30, 2014

    OXFORD PKS MEN BEARING UHMWPE MED SZ 4

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code NRA·October 10, 2012

    ACCURUS 800CS

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·July 29, 2010

    STERNALOCK 6 HOLE STRAIGHT PLATE

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·July 6, 2015