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

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    Filters Regulation: Us FDA ×

    SERUM CLONAZEPAM TOXICOLOGY CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    IntelliCartTM System

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

    MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER

    FDA 510(k)
    FDA Unclassified ·Unknown

    SIGMA 300 DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·June 10, 2014

    ACCU-CHEK ® MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·December 10, 2012

    QUARTET

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code OJX·June 23, 2015

    EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.

    FDA Enforcement
    Class II ·Terminated·Dako North America Inc.·November 11, 2015