BEUDAMED
    22 results · 26ms · Sources: EU EUDAMED, US FDA

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    ATLAS SPINE VERTEBRAL BODY REPLACEMENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    C-Taper Head

    FDA UDI
    Howmedica Osteonics Corp.·07613327016321·Low Friction Ion Treatment

    Epatch Sensor

    FDA UDI
    BRAEMAR MANUFACTURING, LLC·B146EP080·

    NOBELACTIVE INTERNAL RP 4.3X8.5MM

    FDA Adverse Event
    Injury ·NOBEL BIOCARE AB·Product code DZE·August 17, 2020

    NOBELACTIVE INTERNAL NP 3.5X8.5MM

    FDA Adverse Event
    Injury ·NOBEL BIOCARE AB·Product code DZE·September 9, 2020

    NOBELACTIVE INTERNAL NP 3.5X8.5MM

    FDA Adverse Event
    Injury ·NOBEL BIOCARE AB·Product code DZE·September 9, 2020

    NOBELACTIVE INTERNAL RP 4.3X8.5MM

    FDA Adverse Event
    Injury ·NOBEL BIOCARE AB·Product code DZE·August 17, 2020

    CROSSFIRE 10 DEG INSERT

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JDI·May 6, 2013

    MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TRANSFX ANGLED RODS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CROSSFIRE 10 DEG INSERT

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS CORK·Product code JDI·May 13, 2008

    TRIDENT 10 CROSSFIRE INSERT 32MM ID

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS CORK·Product code MEH·May 26, 2010

    CP87170 DE MUENCHEN

    FDA Adverse Event
    Death ·SORIN GROUP ITALIA·Product code DTZ·July 15, 2011

    EMAX 2 PLUS MOTOR

    FDA Adverse Event
    Malfunction ·THE ANSPACH EFFORT, INC.·Product code HBC·April 11, 2013

    GATEWAY BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code GBA·April 19, 2011

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·June 19, 2008

    TRIDENT 0 DEG X3 INSERT 32MM HEAD

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code LPH·October 9, 2013

    TRIDENT 10° X3 INSERT 32MM ID

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code LPH·February 13, 2018

    DiaSorin Anti-Cardiolipin IgA ELISA kit for the detection in human serum or plasma of antoantibodies specific for Cardiolipin IgA. Catalog No.: 7800. Manufactured for DiaSorin Inc., 1951 Northwestern Avenue, Stillwater, MN 55082-0285

    FDA Recall
    Terminated ·Diasorin Inc.·Product code MID·January 23, 2004

    VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib supports. The VEPTR/VEPTR II devices mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·September 9, 2015