BEUDAMED
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    SPINE FRONTIER INDUS ACP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior Cervical Plate System under 501(k) clearance number K121060. The Invue Driver is an instrument consisting of a Radel handle, a shaft and hexalobe-like tip with a 4.0mm split, which allows the driver to collapse to fit into a screw and expand to retain the screw.

    FDA Enforcement
    Class II ·Terminated·SpineFrontier, Inc.·August 14, 2013

    Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior Cervical Plate System under 501(k) clearance number K121060. The Invue Driver is an instrument consisting of a Radel handle, a shaft and hexalobe-like tip with a 4.0mm split, which allows the driver to collapse to fit into a screw and expand to retain the screw.

    FDA Recall
    Terminated ·SpineFrontier, Inc.·Product code HXX·May 10, 2013

    NC Healing Abutment, bottle shape

    FDA UDI
    BIO CONCEPT Co., Ltd.·06947600305309·

    AF541

    FDA UDI
    Respironics, Inc.·00606959024380·AF541 Mask with Entrainment Elbow, Leak 1, with...

    NA

    FDA UDI
    Nuvasive, Inc.·00195377161727·RELINE-O Gearshift Probe, Lum Str Depth

    NA

    FDA UDI
    Nuvasive, Inc.·00195377161710·RELINE-O Gearshift Probe,Thor Crvd Depth

    NA

    FDA UDI
    Nuvasive, Inc.·00195377161734·RELINE-O Gearshift Probe, Lum Crvd Depth

    NA

    FDA UDI
    Nuvasive, Inc.·00195377161703·RELINE-O Gearshift Probe, Thor Str Depth

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515016378·Hegar-Baumgartner NH, serr, 5 1/2"

    Malibu™

    FDA UDI
    Seaspine Orthopedics Corporation·10889981029975·PRECONTOURED ROD, 5.5 x 60mm

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450408896·

    Life Instruments

    FDA UDI
    Life Instrument Corporation·M93071210600C0·Custom American Curette #6/0 str.

    Life Instruments

    FDA UDI
    Life Instrument Corporation·M93071210601C0·Custom American Curette #6/0 angled

    Life Instruments

    FDA UDI
    Life Instrument Corporation·M930712106000·American Curette #6/0 Str.

    Life Instruments

    FDA UDI
    Life Instrument Corporation·M930712106010·American Curette #6/0 angled

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197490283·Super-Cut Peck-Joseph Dissecting Scissor straig...

    FRESENIUS ICARE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SIESTA MEDICAL, INC., PRELUDE TONGUE SUSPENSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523103836·Hemispherical Shell, Cluster Hole, 60mm