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

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    Facet Manatee Reusable Lancing Base

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

    AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBP

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    Best-AV2 Pro-Sport(tm)

    FDA 510(k)
    FDA Class 2 ·Neurology

    INTRALASE FS2 LASER

    FDA Adverse Event
    Injury ·AMO MANUFACTURING USA, LLC.·Product code HNO·August 15, 2011

    SENSOR ENLITE

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OZO·November 4, 2014

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code NIQ·July 12, 2013

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025