BEUDAMED
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    RANDOX ALBUMIN

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Polystar HK

    FDA UDI
    Merz Dental GmbH·D7091984494·anteriors; shade C2; mould 102

    LABELING CHANGES TO PULSE GENE. & PULSE GENE. LEAD

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    DAIG OBTURATOR, CATHETER INTRODUCER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DURATA STS OPTIM ACTIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·February 28, 2013

    INRATIO2

    FDA Adverse Event
    Injury ·ALERE SAN DIEGO, INC·Product code GJS·February 1, 2011

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·August 6, 2014

    InterGard Knitted Collagen Coated Vascular prostheses marketed under 510(k) # K964625; InterGard Woven Collagen Coated Vascular prostheses marketed under 510(k} #K970843 and K984294.

    FDA Recall
    Terminated ·Intervascular S.A.S. Zone Industrielle Athelia I La Ciotat Cedex France·Product code DSY·December 9, 2009