BEUDAMED
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    Endoskeleton TCS Interbody Fusion Device

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ENDOSKELETON® TCS NO 6 SWIVEL DRIVER

    FDA Adverse Event
    Malfunction ·TITAN SPINE, LLC·Product code HXX·January 28, 2016

    ProLift

    FDA UDI
    Life Spine, Inc.·00190837117610·

    ProLift

    FDA UDI
    Life Spine, Inc.·00190837086305·

    KIMBERLY-CLARK PURPLE NITRILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) AND KIMBERLY-CLARK PURPLE NITRILE XTRA POWDER-

    FDA 510(k)
    FDA Class 1 ·General Hospital

    STATUSFIRST CHF (CONGESTIVE HEART FAILURE) NT-PROBNP, MODEL 20204

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    FDA Adverse Event
    Injury ·RICE CREEK MFG·Product code LWP·June 7, 2013

    JUGGERKNOT 2.9 W/CUTTING ND

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code MBI·October 8, 2014

    PENUMBRA SYSTEM SEPARATOR 032

    FDA Adverse Event
    Malfunction ·PENUMBRA INC.·Product code NRY·June 24, 2011

    ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code FCG·December 26, 2017

    SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 26, 2014

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.

    FDA Enforcement
    Class II ·Terminated·Medical Intelligence Medizintechnik Gmbh·July 31, 2019