BEUDAMED
    10 results · 26ms · Sources: EU EUDAMED, US FDA

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    MC-SERIES SURGICAL CAMERAS

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556705282·GC Initial™ LF Dentin DB2, 20g

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228710571·GC Initial™ LF Dentin DB2, 20g

    COLONIC & ENEMA NOZZLE

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

    ANESTHESIA MACHINE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    OT PING METER

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

    PRECISION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 12, 2010

    SWAN-GANZ CCOMBO CCO/SVO2/VIP THERMODILUTION CATHETER

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES, PR·Product code DYG·December 12, 2012

    Axium Detachable Coil System Model Number: QC-2-2-3D. The AXIUM DETACHABLE COIL SYSTEM consists of a platinum embolization coil attached to a composite implant delivery pusher with a radiopaque positioning marker and a hand-held I.D. (instant detacher) which when activated detached the coil from the delivery pusher tip. Some of the AX IUM Detachable coils are enlaced with PGLA microfilaments or Nylon microfilaments. I.D. (instant detached) is sold separately.

    FDA Recall
    Terminated ·Micro Therapeutics Inc, dba ev3 Neurovascular·Product code HCG·November 12, 2008

    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