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    PROCESS INDICATOR TAPE FOR STEAM STERILIZATION

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Gyrus ACMI

    FDA UDI
    Gyrus ACMI, LLC·00821925014381·WEHRS INCUS PROSTHESIS AVERAGE LENGTH, SINGLE N...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694046398·PrimaLIF LLIF PEEK Implant, 9mm X 26mm X 40mm, ...

    FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BRONCHOVIDEOSCOPE OLYMPUS XBF-D160HM

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM - POSTERIOR

    FDA Adverse Event
    Injury ·BARD SHANNON LIMITED·Product code FTL·May 24, 2013

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·June 21, 2011

    GE OEC 9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 3, 2008

    TOTAL KNEE REPLACEMENT

    FDA Adverse Event
    Malfunction ·STANMORE IMPLANTS WORLDWIDE LTD·Product code KRO·November 10, 2016

    PATIENT SPECIFIC TOTAL FEMUR

    FDA Adverse Event
    Injury ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·August 15, 2018

    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