BEUDAMED
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    PRELUDE SHEATH INTRODUCER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EMERGE?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LOX·February 11, 2026

    PHYSIOGLOVE ES WITH ECG ANALYSIS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ANMP (ACOUSTIC NEURO MODULATION PROTOCOL)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    RESERVOIR 1.8ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·May 24, 2013

    RIATA ST ACTIVE FIXATION

    FDA Adverse Event
    Death ·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·September 30, 2014

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·June 16, 2011

    COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code HES·July 17, 2017

    CELLTRACKS ANALYZER II¿ (Product Code 9555) Product Usage: The CELLTRACKS ANALYZER II¿ is a semi-automated fluorescence microscope, consisting of the analyzer, a dedicated computer with CELLTRACKS¿ software, monitor, keyboard, mouse and uninterruptible power supply (UPS). The system also supports an optional Remote Review Workstation (RRW), which consists of a dedicated computer with CELLTRACKS¿ software, monitor, keyboard and mouse. Use of this product requires training and should be used under the supervision of laboratory management. The CELLTRACKS ANALYZER II¿ is for analysis of rare cells that are isolated from biological fluids including whole blood. It is used in conjunction with the CELLTRACKS¿ AUTOPREP¿ System, which automates and standardizes the sample preparation with specific reagent kits. An optional Remote Review Workstation is also available to provide the capability to review images and report results remotely.

    FDA Enforcement
    Class II ·Terminated·Veridex, LLC·March 19, 2014

    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