BEUDAMED
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    ACE CEDIA PHENOBARBITAL ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    3M™ ESPE™

    FDA UDI
    3M COMPANY·30605861012837·3M™ ESPE™ Gold Anodized Crowns - Bicuspid Set, ...

    ETG-4000 OPTICAL TOPOGRAPHY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Xpert Norovirus, GeneXpert Dx Systems (GX-I, GX-11, GX-IV, GX-XVI), GeneXpert Infinity-48 System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System

    FDA 510(k)
    FDA Class 2 ·Microbiology

    FR2

    FDA Adverse Event
    PHILIPS MEDICAL SYSTEMS·Product code MKJ·December 17, 2010

    ENERGEN

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·February 4, 2013

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·July 17, 2014

    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