BEUDAMED
    9 results · 28ms · Sources: EU EUDAMED, US FDA

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    ICON STREP B IMMUNOENZYMETRIC ASSAY

    FDA 510(k)
    FDA Class 1 ·Microbiology

    O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ZAP DUAL CURING LIGHT

    FDA 510(k)
    FDA Class 2 ·Dental

    PRECISION SPECTRA®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 30, 2014

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·January 3, 2013

    LIGASURE ATLAS HANDSWITCHING 37CM

    FDA Adverse Event
    Malfunction ·COVIDIEN LLC (SHANGHAI)·Product code GEI·November 12, 2010

    CONFIRM ANTI-HER-2/NEU (4B5) PRIMARY ANTIBODY

    FDA Adverse Event
    Other ·VENTANA MEDICAL SYSTEMS, INC.·Product code MVC·March 20, 2012

    VENTANA PATHWAY anti-HER-2/neu (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY (PATHWAY HER2 (4B5)); Model Number: 790-2991, Lot number: 680957, in vitro diagnostic.

    FDA Recall
    Terminated ·Ventana Medical Systems Inc·Product code MVC·September 17, 2009

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012