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

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    SCMT UMBILICAL CLAMP

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556706210·GC Initial™ LF Translucent Mod. TM-02, 20g

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228710751·GC Initial™ LF Translucent Mod. TM-02, 20g

    TERUMO DIGITAL BLOOD PRESSURE MONITOR ES-H55A

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Calix-C Cervical Interbody Spacer

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 13, 2014

    ENDOTAK RELIANCE

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVY·October 15, 2010

    PROGRASP FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·December 12, 2012

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015