BEUDAMED
    10 results · 26ms · Sources: EU EUDAMED, US FDA

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    RD 140 SURGICAL BENDER

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228700841·GC Initial™ MC Enamel Intensive EI-14, 20g

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556701437·GC Initial™ MC Enamel Intensive EI-14, 20g

    InterLock Trocar

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MONTBLANC IMPLANTOLOGY CONTRA ANGLE CONTROL

    FDA 510(k)
    FDA Class 1 ·Dental

    FINGER PYROLYTIC CARBON PROSTHESIS

    FDA Adverse Event
    Injury ·ASCENSION ORTHOPEDICS, INC.·Product code KYJ·October 1, 2010

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·December 12, 2012

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND·Product code CBK·April 28, 2014

    IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal (ISP) LX SPECT IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·August 20, 2014

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020