BEUDAMED
    10 results · 21ms · Sources: EU EUDAMED, US FDA

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    MODIFICATION TO STRYKER SPINE OASYS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Symmetry Malis®

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482035962·Symmetry® Bipolar Forceps; Hardy Bayonet; Strai...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450180242·

    MIDAS TOUCH NITRILE EXAMINATION GLOVES-POWDERED

    FDA 510(k)
    FDA Class 1 ·General Hospital

    VASOVIEW 5 HARVESTING CANNULA

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

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 5, 2024

    DURATA STS OPTIM PASSIVE FIXATION, DF4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·April 26, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 6, 2011

    E SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·July 17, 2008

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014