BEUDAMED
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    OCTANE VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587L082270120·8mm H x 22mm W x 70mm L XLIF Trial 12 degree Lo...

    MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA

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

    STRYKER CROSS-PINNED INTERFERENCE SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NEURON DELIVERY CATHETER 053

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code DQY·March 16, 2010

    WAVEWRITER ALPHA?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 14, 2025

    MANDIBLE-CORTSCR Ø2 SELF-TAP L6 TI

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code HWC·April 29, 2013

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·May 9, 2011

    CAPIO OPEN ACCESS SUTURE CAPTURING DEVICE

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code MFJ·July 24, 2008

    Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017

    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