BEUDAMED
    12 results · 17ms · Sources: EU EUDAMED, US FDA

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    URESIL GENERAL PURPOSE DRAINAGE CATHETER

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·34546540244377·BONE SCREWS, CROSS-FIT, SELF-TAPPING

    Malibu

    FDA UDI
    Seaspine Orthopedics Corporation·10889981080563·Polyaxial Screw Driver, 8.0+

    McKesson

    FDA UDI
    MCKESSON MEDICAL-SURGICAL INC.·20612479275915·MASK, PROC LOOPS ASTM3 ANTIFOG

    THE KINEGRAPH VMA SOFTWARE, THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLLECTION DEVICE

    FDA 510(k)
    FDA Class 2 ·Radiology

    DRI ECSTASY URINE CALIBRATORS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    POLYAXIAL SCREW DRIVER 8.0+

    FDA Adverse Event
    Malfunction ·SEASPINE, INC.·Product code KWQ·April 15, 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 Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·February 19, 2014

    HS III PROXIMAL SEAL SYSTEM 3.8MM

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC.·Product code DXC·May 13, 2014

    9900

    FDA Adverse Event
    Malfunction ·Product code JAA·July 10, 2015

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·January 11, 2013

    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