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

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    Bone Suppression Software

    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...

    Delta®

    FDA UDI
    MEDTRONIC PS MEDICAL, INC.·00613994908230·SHUNT 24028-1 DELTA ASY REG SNAP PER 1.0

    Delta®

    FDA UDI
    MEDTRONIC PS MEDICAL, INC.·00643169497160·SHUNT 24028-1 DELTA ASY REG SNAP PER 1.0

    LPS METAPHYSEAL SLEEVE (LIMB PRESERVATION SYSTEM)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FLEXI-LUME LED SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 24, 2008

    COLLEAGUE

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

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 8, 2013

    MultiDiagnost Eleva; x-ray system. Product Codes: 708032, 708036

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·August 10, 2016

    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