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

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    CONQUEST FN

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MYOSURE ROD LENS SCOPE SEALS

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ARTHROCARE ARTHROWANDS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SHAFT FOR 90° SCREWDRIVER

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code DZI·December 18, 2018

    MAINFRAME 8253001 NIM RESPONSE 3.0

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code ETN·February 24, 2014

    EMG TUBE 8229737 3PK NIM TRIVANTAGE 7MM

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED, INC.·Product code ETN·November 12, 2014

    ATTAIN STARFIX

    FDA Adverse Event
    Injury ·MPRI·Product code OJX·June 7, 2013

    8800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 24, 2011

    HS HAND CONTROLLED CURVED SHEAR

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code LFL·September 10, 2008

    NIM® EMG - ENDOTRACHEAL TUBE - TRIVANTAGE®

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code ETN·July 19, 2016

    NIM® 3.0 MAINFRAME

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED INC.·Product code ETN·January 14, 2015

    Ø1.5MM DRILL BIT W/6MM STOP 13MM F/90° SCRWDRVR MTRXMANDBL

    FDA Adverse Event
    Malfunction ·SYNTHES SELZACH·Product code DZI·November 13, 2017

    NIM® 3.0 MAINFRAME

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED INC.·Product code ETN·August 15, 2016

    NIM® PROBE

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code ETN·March 23, 2018

    NIM® PROBE

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code ETN·May 11, 2015

    LIGASURE

    FDA Adverse Event
    Malfunction ·COVIDIEN MFG DC BOULDER·Product code GEI·March 21, 2022

    ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012