BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    OXY-1 System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Ponto

    FDA UDI
    Oticon Medical AB·05712149026494·PONTO 5 SUPERPOWER, SIL

    SMARTSTEP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SMARTGUARD NIGHT GUARD, SMARTGUARD ORIGINAL, SMARTGUARD NIGHT GUARD ORIGINAL, SMARTGUARD ELITE

    FDA 510(k)
    FDA Unclassified ·Unknown

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 4, 2014

    3002 SECURE II

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·August 16, 2011

    CASHMERE 14 - PLATINUM MICROCOIL

    FDA Adverse Event
    Injury ·MICRUS ENDOVASCULAR, LLC·Product code HCG·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

    The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.

    FDA Enforcement
    Class II ·Ongoing·Abbott Medical·January 1, 2025