BEUDAMED
    11 results · 30ms · Sources: EU EUDAMED, US FDA

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    MAXIM PLASTIC APPLICATOR & NON-APPLICATOR TAMPONS

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

    BIOCELLECT

    FDA 510(k)
    FDA Class 2 ·Dental

    HEART 2005

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

    PRISMAFLEX

    FDA Adverse Event
    Injury ·GAMBRO LUNDIA AB·Product code KDI·May 6, 2010

    PRISMAFLEX

    FDA Adverse Event
    Injury ·GAMBRO LUNDIA AB·Product code KDI·November 5, 2010

    PRISMAFLEX

    FDA Adverse Event
    Injury ·GAMBRO LUNDIA AB·Product code KDI·November 25, 2010

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·April 12, 2013

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 6, 2011

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYDRO

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR·Product code MIH·July 23, 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