BEUDAMED
    19 results · 20ms · Sources: EU EUDAMED, US FDA

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    LAST IMAGE HOLD

    FDA 510(k)
    FDA Class 1 ·Radiology

    MALIBU SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EVS 3643

    FDA 510(k)
    FDA Class 2 ·Radiology

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    FDA Adverse Event
    Malfunction ·RICE CREEK MFG·Product code DXY·February 9, 2013

    TELIGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 7, 2011

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 23, 2014

    TI MIRS POLYAXIAL SCREW BODY

    FDA Adverse Event
    Injury ·SYNTHES MEZZOVICO·Product code NKB·August 7, 2017

    TI MIRS POLYAXIAL SCREW BODY

    FDA Adverse Event
    Injury ·SYNTHES MEZZOVICO·Product code NKB·August 7, 2017

    TI MIRS LOCKING CAP

    FDA Adverse Event
    Injury ·SYNTHES MEZZOVICO·Product code NKB·August 7, 2017

    TI MIRS POLYAXIAL SCREW BODY

    FDA Adverse Event
    Injury ·SYNTHES MEZZOVICO·Product code NKB·August 7, 2017

    TI MIRS POLYAXIAL SCREW BODY

    FDA Adverse Event
    Injury ·SYNTHES MEZZOVICO·Product code NKB·August 7, 2017

    TI MIRS LOCKING CAP

    FDA Adverse Event
    Injury ·SYNTHES MEZZOVICO·Product code NKB·August 7, 2017

    TI MIRS LOCKING CAP

    FDA Adverse Event
    Injury ·SYNTHES MEZZOVICO·Product code NKB·August 9, 2017

    TI MIRS LOCKING CAP

    FDA Adverse Event
    Injury ·SYNTHES MEZZOVICO·Product code NKB·August 9, 2017

    TI MIRS LOCKING CAP

    FDA Adverse Event
    Injury ·SYNTHES MEZZOVICO·Product code NKB·August 7, 2017

    TI MIRS LOCKING CAP

    FDA Adverse Event
    Injury ·SYNTHES MEZZOVICO·Product code NKB·August 9, 2017

    TI MIRS LOCKING CAP

    FDA Adverse Event
    Injury ·SYNTHES MEZZOVICO·Product code NKB·August 9, 2017

    Malibu Polyaxial Screwdriver, 8.0 Plus, Model Number 91-2109; Malibu Polyaxial Screwdriver, Standard, Model Number 91-2110. 510(k): 91-2109 K061342. 91-2110 K051942. The Malibu" System is intended to be used as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur. The System is comprised of single use pedicle screws of varying reduction height, rods, rod connectors, etc. and an accompanying set of reusable surgical instruments. Some of the surgical instruments are specific to the system and others are general surgical instruments. The polyaxial screwdriver is specific to the polyaxial screws in the system.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·February 19, 2014

    Malibu Polyaxial Screwdriver, 8.0 Plus, Model Number 91-2109; Malibu Polyaxial Screwdriver, Standard, Model Number 91-2110. 510(k): 91-2109 K061342. 91-2110 K051942. The Malibu" System is intended to be used as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur. The System is comprised of single use pedicle screws of varying reduction height, rods, rod connectors, etc. and an accompanying set of reusable surgical instruments. Some of the surgical instruments are specific to the system and others are general surgical instruments. The polyaxial screwdriver is specific to the polyaxial screws in the system.

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code NKB·January 22, 2014