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

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    VECTRA MAGNETIC RESONANCE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    HI-ART SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    MYSAFETY SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SUPRACONDYLAR NAIL T2 SCN 10 X 200 MM

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS ¿ KIEL·Product code HSB·July 17, 2012

    SELUTE PICOTIP

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·January 14, 2013

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·November 22, 2010

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·July 3, 2014

    Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·September 30, 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