BEUDAMED
    23 results · 28ms · Sources: EU EUDAMED, US FDA

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    Arthrex iBalance UKA System Vitamin E Tibial Bearing

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517292315·CoRoent® XLFW, 10x22x60mm

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517731067·CoRoent XL+, 10x18x60mm 15°

    Vilex Power Accessory

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731122254·KWire .062x4" (1.6x100mm)

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523104079·T³ Acetabular Hemispherical Shell, Cluster Hole...

    TT101, MODELS TT 101-1,-2,-3,-4,-5,-6,-7,-8

    FDA 510(k)
    FDA Unclassified ·Unknown

    SIESTA MEDICAL, INC., PRELUDE TONGUE SUSPENSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    CARELINK

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code KRG·October 10, 2014

    COULTER LH 750 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·June 17, 2011

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 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 Enforcement
    Class II ·Terminated·SpineFrontier, Inc.·August 14, 2013

    BIODESIGN OTOLOGIC REPAIR GRAFT

    FDA Adverse Event
    Injury ·COOK BIOTECH·Product code KHJ·September 19, 2018

    BIODESIGN OTOLOGIC REPAIR GRAFT

    FDA Adverse Event
    Injury ·COOK BIOTECH·Product code KHJ·March 8, 2021

    BIODESIGN OTOLOGIC REPAIR GRAFT

    FDA Adverse Event
    Injury ·COOK BIOTECH·Product code KHJ·January 11, 2018

    GRACE MEDICAL, INC. NOTCHED TITANIUM BUCKET HANDLE

    FDA Adverse Event
    Injury ·GRACE MEDICAL, INC.·Product code ETB·July 3, 2019

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code NEW·July 14, 2021

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code NEW·July 14, 2021

    BIODESIGN OTOLOGIC REPAIR GRAFT

    FDA Adverse Event
    Injury ·COOK BIOTECH·Product code KHJ·October 14, 2019

    ECHELON ENDOPATH STAPLER

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 29, 2021

    ECHELON ENDOPATH STAPLER

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 29, 2021