BEUDAMED
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    KLASSIC KNEE TIBIAL STEM EXTENSION

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    QCT Pro Asynchronous Calibration Module, CliniQCT

    FDA UDI
    MINDWAYS SOFTWARE, INC.·B052DIASYNC0·The QCT Pro Asynchronous Calibration Module is ...

    U-RIGHT EAR THEMOMETER, MODELS TD-1115 AND TD-1118

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VST3

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SPECIALTY TRIDENT HEX DRIVER FOR USE WITH CURVED CUP IMPACTOR PER FILE H1385

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS-MAHWAH·Product code LXH·June 3, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 27, 2011

    GE OEC 9900

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

    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