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

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    CAPSTONE SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code LXH·February 10, 2020

    ArgenZ ST 98x16 ML D2

    FDA UDI
    ARGEN CORPORATION, THE·D818121760·Dental porcelain/ceramic restoration kit

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694045544·PrimaLIF LLIF PEEK Implant, 17mm X 18mm X 60mm,...

    PINNACLE

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295010432·PINNACLE CANCELLOUS BONE SCREW 6.5mm x 60mm

    GRIPTION

    FDA UDI
    DEPUY (IRELAND)·10603295381433·GRIPTION TF SCREW 5.5mm x 60mm

    ELEGANT BLUE, WHITE, PINK POWDER FREE, NITRILE EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    NAVITRACK SYSTEM-OPTICAL TKR CT-LESS, MODEL 900.120

    FDA 510(k)
    FDA Class 2 ·Neurology

    VANGUARD CR ILOK FEM-RT 67.5

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·May 21, 2013

    PINNACLE 300 ACET CUP 50MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·September 26, 2014

    GEM MICROVASCULAR ANASTOMOTIC COUPLER

    FDA Adverse Event
    Malfunction ·SYNOVIS SURGICAL INNOVATIONS·Product code MVR·May 20, 2011

    ACCESS ACCUTNI REAGENT

    FDA Adverse Event
    Injury ·BECKMAN COULTER·Product code MMI·September 15, 2016

    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