BEUDAMED
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    Sickbay Clinical Platform

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517565952·CoRoent Ant TLIF PEEK, 14x13x30mm 4°

    STRAIGHT PLATE

    FDA UDI
    Biomet Orthopedics, LLC·00887868004216·

    BLADDER SCANNER

    FDA 510(k)
    FDA Class 2 ·Radiology

    Q-CAP NEEDLE-FREE RECONSTITUTION 13MM VIAL ADAPTER, MODEL 6100-01

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ECHELON LINEAR CUTTER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·October 6, 2014

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MALTA·Product code LHI·June 3, 2013

    PROFEMUR(R) MODULAR FEMORAL NECK

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LWJ·June 29, 2011

    COULTER LH 500 Hematology Analyzer part numbers: 178832, 178833, and 178834 software versions 1A and 1A2. The LH 500 Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter For In Vitro Diagnostic Use in clinical laboratories. The LH %500 Analyzer also provides a semi-automated reticulocyte analysis.

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code GKZ·August 12, 2004