BEUDAMED
    11 results · 23ms · Sources: EU EUDAMED, US FDA

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    Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR

    FDA 510(k)
    FDA Class 2 ·Radiology

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017965·K-Wire, Single Ended, Trocar Point, Diameter Si...

    SOFTSEAL HSG CATHETER

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    EXCELLA III-D SPINAL DEFORMITY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MY3D PERSONALIZED PELVIC RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·ONKOS SURGICAL INC.·Product code LPH·June 23, 2025

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 10, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011

    C21512 RU NOVOSIBIRSK

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·July 17, 2013

    PRODIGY AUTOCODE

    FDA Adverse Event
    Injury ·OK BIOTECH CO., LTD.·Product code NBW·October 24, 2017

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013