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    ALIVECOR HEART MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257142493·20-30 MFW VITALITY CALF CT CHOC III

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257125373·20-30 MV FOR MEN CLSC CALF STD BROWN III

    ECAT HRRT

    FDA 510(k)
    FDA Class 2 ·Radiology

    CONSENSUS CS2 PLUS ACETABULAR INSERT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BMT GB KNEE STM 12X40

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code OIY·June 1, 2022

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·June 3, 2013

    QUATTRODE LEAD WIDE SPACED, 90 CM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·June 21, 2011

    RENU MULTIPLUS MULTI-PURPOSE SOLUTION

    FDA Adverse Event
    Injury ·BAUSCH & LOMB·Product code LPN·August 28, 2008

    GALAFLEX

    FDA Adverse Event
    Injury ·TEPHA, INC·Product code OOD·February 28, 2020

    C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide sterotactic radiosurgery and precision radio-therapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·September 24, 2014

    C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. The UNIQUE is not sold in the US. Product Usage: The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. The UNIQUE is a single energy medical linear accelerator. UNIQUE is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·December 11, 2013