BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    COMPASS STEREOTACTIC POSITIONING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    K-Wire and Steinmann Pin Dispensers

    FDA UDI
    KEY SURGICAL, INC.·00849771046370·K-Wire and Steinmann Pin Dispensers, Dispensing...

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228710461·GC Initial™ LF Opaqus Dentin ODD4, 20g

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556705831·GC Initial™ LF Opaqus Dentin ODD4, 20g

    RISE Splint

    FDA UDI
    TACTICAL MEDICAL SOLUTIONS, LLC·00818630015536·The RISE™ (Rigid Immobilization System for Extr...

    SeaSpine Cambria System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SYNTHES CHRONOS COMPOSITE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OT ULTRA2 METER

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

    TELIGEN

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 15, 2010

    PRIMEADVANCED

    FDA Adverse Event
    Malfunction ·IPG MFG SWITZERLAND·Product code LGW·June 26, 2015

    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