BEUDAMED
    13 results · 20ms · Sources: EU EUDAMED, US FDA

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    TSX-101A/H AQUILION 64 SP CT SCANNER; TSX-101A/I AQUILION 32 SP CT SCANNER

    FDA 510(k)
    FDA Class 2 ·Radiology

    MB 103 MILLENNIUM BLADES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    PREFERENCE TREATMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    UNKNOWN COPELAND SHOULDER

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code HSD·April 14, 2017

    COPELAND SH HUM SZ4 STND PLUS

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code HSD·June 8, 2016

    UNKNOWN COPELAND HEMIARTHROPLASTY SHOULDER

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code HSD·October 21, 2016

    UNKNOWN COPELAND RESURFACING SHOULDER

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code HSD·May 16, 2017

    UNKNOWN COPELAND SHOULDER GLENOID COMPONENT

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code HSD·July 5, 2017

    I-STAT TROPONIN (CTNI) CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code MMI·February 14, 2012

    CAPSUREFIX NOVUS MRI

    FDA Adverse Event
    Injury ·MPRI·Product code NVN·April 10, 2013

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    KENSTONE METAL·Product code ITJ·September 2, 2014

    KAPPA 400 DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code DXY·April 12, 2011

    Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018