BEUDAMED
    9 results · 21ms · Sources: EU EUDAMED, US FDA

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    AVACEN 100

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SMITH & NEPHEW ELECTROTHERMAL 20S SPINE GENERATOR, MODEL 7209975

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM; S.M.A.R.T. RE-FLEX BILIARY ELF-EXPANDING STENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    COCR FEMORAL HEAL 32 SIZE M

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL, SA·Product code JDI·August 19, 2014

    COCR FEMORAL HEAD 32 SIZE M

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·August 19, 2014

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 2, 2014

    AEQUALIS

    FDA Adverse Event
    Injury ·TORNIER SAS·Product code KWS·May 23, 2013

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·June 20, 2011

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015