BEUDAMED
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    MTA2.1 MATERIAL

    FDA 510(k)
    FDA Class 2 ·Dental

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694046428·PrimaLIF LLIF PEEK Implant, 9mm X 26mm X 55mm, ...

    Imetric

    FDA UDI
    Imetric 4D Imaging Sàrl·07640243230388·ICamBody Screw Set for ICB MUA M1.4 L9.55

    ANYRIDGE INTERNAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.01 AND INTELLIVUE CLINICAL NETWORK ON VLAN

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Imetric

    FDA UDI
    Imetric 4D Imaging Sàrl·07640243230470·ICamBody Screw Set for ICB MUA M1.4 L9.55 Con.

    ENDURO MENISCAL COMPONENT F2 22MM

    FDA Adverse Event
    Malfunction ·AESCULAP AG & CO. KG·Product code KRO·December 9, 2014

    ENDURO MENISCAL COMPONENT F2 10MM

    FDA Adverse Event
    Malfunction ·AESCULAP AG AND CO. KG·Product code KRO·January 14, 2015

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·June 3, 2013

    NXSTAGE SYSTEM ONE

    FDA Adverse Event
    Injury ·NXSTAGE MEDICAL, INC.·Product code KDI·August 28, 2008

    ASR UNI FEMORAL IMPL SIZE 53

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·June 21, 2011

    ENDURO MENISCAL COMPONENT F1 10MM

    FDA Adverse Event
    Injury ·AESCULAP IMPLANT SYSTEMS·Product code KRO·October 11, 2016

    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