BEUDAMED
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    UNIVERSAL DISTAL RADIUS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BIPOLAR HEAD 28 X 46 MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·March 18, 2015

    ELECTRONIC SPHYGMOMANOMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    STIMULEN COLLAGEN

    FDA 510(k)
    FDA Unclassified ·Unknown

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 24, 2013

    QUADRA ASSURA CRT-D, DF-4 CONNECTOR

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

    ATTAIN OTW

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011

    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

    Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

    FDA Enforcement
    Class II ·Terminated·Senseonics, Inc.·November 6, 2019

    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