BEUDAMED
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    AFFINITY CP CENTRIFUGAL BLLOD PUMP WITH CARMEDA BIOACTIVE SURFACE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NA

    FDA UDI
    Smith & Nephew, Inc.·03596010039774·LARGE SELF-RETAINING RETRACTOR 279.4MM

    CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) LIPIDS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    WATERLASE MD TURBO PLUS MODEL 7200XXX

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ARROW CATH RADIAL ARTERY

    FDA Adverse Event
    Injury ·ARROW INTERNATIONAL, INC.·Product code DQX·May 8, 2013

    LEVEEN NEEDLE ELECTRODE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code GEI·June 2, 2011

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC CORPORATION·Product code NIQ·August 12, 2008

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·February 4, 2014

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021