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    FDA 510(k)
    FDA Class 2 ·Radiology

    FOGARTY CORKSCREW

    FDA UDI
    Edwards Lifesciences LLC·00690103042429·FOGARTY CORKSCREW CATHETER 5F 8MM 80CM

    GEN4 INTERACTIVE

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828155885·GEN4 INTERACTIVE

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319705032·Allis Tissue Forceps 6" (15cm), 5x6 teeth

    MINI L.E.D. OEM MODULE

    FDA 510(k)
    FDA Class 2 ·Dental

    EXPORT XT CATHETER, EXPORT AP CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FOGARTY ARTERIAL EMBOLECTOMY II CATHETER

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES, PR·Product code DXE·August 7, 2012

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    JUMAO HEALTHCARE EQUIPMENT·Product code IOR·October 3, 2014

    M2A-TAPER LINER SZ 41/32

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWY·May 31, 2013

    EZ-PRO 2 AMBUL COT

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·May 31, 2011

    PROXIMAL TIBIA JTS (DISTAL FEMORAL COMPONENT)

    FDA Adverse Event
    Injury ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·November 28, 2018

    DISTAL FEMUR JTS

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

    DISTAL FEMUR JTS / PROXIMAL TIBIA MIG

    FDA Adverse Event
    Injury ·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·April 7, 2015

    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

    Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc. Oncology Systems·May 22, 2013