BEUDAMED
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    Filters Status: Terminated ×

    Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.

    FDA Enforcement
    Class III ·Terminated·Illumina Inc·December 31, 2014

    8870 software application card versions AAA 02, BBB 04, BBC 02, and BBD 01, which is used in conjunction with the Model 8840 N''Vision Clinician Programmer.

    FDA Recall
    Terminated ·Medtronic Inc, Neurological & Spinal Division·Product code LKK·August 24, 2004

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015