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

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    MEDISENSE PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM FOR BLOOD GLUCOSE TESTING

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·June 28, 2018

    NEEDLE 30X1/2 RB

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·May 27, 2021

    ACETABULAR PLATES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DRYSTAR, MODEL 4500M

    FDA 510(k)
    FDA Class 2 ·Radiology

    BD PRECISIONGLIDE NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·July 22, 2021

    NEEDLE 30X1/2 RB

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·January 15, 2021

    BD ULTRA-FINE¿ SYRINGES

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·October 2, 2018

    BD ULTRA-FINE¿ SYRINGES

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·August 13, 2018

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM

    FDA Adverse Event
    Malfunction ·THERAKOS·Product code LNR·March 20, 2013

    9600

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

    SHILEY

    FDA Adverse Event
    Malfunction ·COVIDIEN/FORMERLY TYCO HE·Product code BTO·March 28, 2008

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code NGV·June 11, 2020

    Safety glasses made with "Rage" frames manufactured between February 20, 2014 and February 25, 2014. The color of the frames of the recalled glasses were either white or black. Safety Eye wear

    FDA Enforcement
    Class II ·Terminated·Wal Mart Stores, Inc·June 25, 2014

    StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI is 08717648079467. The GMDN is 47411.

    FDA Enforcement
    Class II ·Terminated·Abbott Vascular·February 22, 2017

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024