BEUDAMED
    10 results · 27ms · Sources: EU EUDAMED, US FDA

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    CEDIA T4 MAB ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CD HORIZON Spinal System, IPC POWEREASE System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VASCULAR SOLUTIONS SCLERO-KIT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TI LOW PROFILE SCREW 6.5X30MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·February 5, 2013

    INRATIO2

    FDA Adverse Event
    Other ·ALERE SAN DIEGO, INC.·Product code GJS·December 23, 2010

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 17, 2014

    ULTRACISION HARMONIC ACE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·October 5, 2015

    ULTRACISION HARMONIC ACE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·November 9, 2015

    HARMONIC ACE 36CM W ERG HANDLE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·January 30, 2018

    PKG, 3MM INSERT, STRAIGHT NEEDLEHOLDER, 20CM, P/N 0250282014 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014