BEUDAMED
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    ERGO++ VERSION 1.7

    FDA 510(k)
    FDA Class 2 ·Radiology

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481113475·LOCATOR R-Tx Abutment for 3.8mm Conelog Connect...

    Conformis Hip System

    FDA UDI
    Conformis, Inc.·00810933030100·REAMER, ACETABULAR, 55MM FULL

    NA

    FDA UDI
    Summit Medical, Inc.·00385640001632·

    FANELLI BILIARY STENT

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    FLEXICOIL - MALLEABLE RECEIVE-ONLY SURFACE COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    TRUEBALANCE

    FDA Adverse Event
    Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·August 13, 2014

    BOOMERANG PEEK FUSION DEVICE

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code MQP·January 14, 2011

    BD ECLIPSE¿ NEEDLE WITH SLIP TIP HUB CONFIGURATION

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·December 20, 2018

    014 HT WINN GUIDE WIRE

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code DQX·April 26, 2013

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·April 22, 2011

    ACCU-CHECK INFORM TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code NBW·July 22, 2008

    Mercury Spinal System DIA 5.5 x 120mm Straight Rod, Part Number: 60101-120. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.

    FDA Enforcement
    Class III ·Terminated·Spinal Elements, Inc·May 15, 2013

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018