BEUDAMED
    11 results · 24ms · Sources: EU EUDAMED, US FDA

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    PALMAZ BILIARY STENT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VuePoint

    FDA UDI
    Nuvasive, Inc.·00887517182173·VuePoint Screw, 4.5x20mm Multi Axial

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111139291·PLACENTA/OVUM CURETTE 26MM

    AFFINITY HCG TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MORTARA INSTRUMENT MODEL X-SCRIBE (TREADMILL INCLUDED)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·January 9, 2013

    IMPLANTIUM

    FDA Adverse Event
    Injury ·DENTIUM USA·Product code HAW·November 9, 2010

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code LWS·July 1, 2014

    ARCOM XL 44-36 STD HMRL BRNG

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·November 2, 2017

    COMP RVRS SHLDR GLNSP STD 36MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·November 2, 2017

    PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017