BEUDAMED
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    MODIFIED OPUS VALPROIC ACID TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    VuePoint

    FDA UDI
    Nuvasive, Inc.·00887517174567·VuePoint Screw, 4.5x38mm Polyaxial Tulip

    Map-iT

    FDA UDI
    ACCESS POINT TECHNOLOGIES, INC.·00818083011963·Fixed, 10 electrode, MPB, 2mm electrode spacing

    Printed Upper ROC Pack for Herbst UL7

    FDA UDI
    SPECIALTY APPLIANCES, LLC·D8199015380·

    PRESSURE RELEASE VALVE W/AUDIBLE, MODEL PRV 20/40/60; WITH T6 ADAPTER, MODEL PRV 120/140/160; T6 ADAPTER, MODEL T6-100

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP)

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    CONTOUR NEXT EZ

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·June 30, 2014

    PROMUS ELEMENT¿ PLUS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·January 8, 2013

    SCULPTRA

    FDA Adverse Event
    Injury ·SANOFIAVENTIS U.S. LLC·Product code LMH·November 12, 2010

    ENDOPATH ETS

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code KOG·December 31, 1997

    ENDOPATH ETS

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code KOG·December 31, 1997

    ENDOPATH ETS

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code KOG·December 31, 1997

    The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285.

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Inc.·April 10, 2019