BEUDAMED
    12 results · 34ms · Sources: EU EUDAMED, US FDA

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    FERRAY EXTRACTOR

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228700831·GC Initial™ MC Enamel Intensive EI-13, 20g

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556701420·GC Initial™ MC Enamel Intensive EI-13, 20g

    Persona®

    FDA UDI
    Zimmer, Inc.·00889024551077·

    Persona®

    FDA UDI
    Zimmer, Inc.·00889024550988·

    LIFEPATCH TM ECG ELECTRODE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    QUANTA LITE H-TTG/DGP SCREEN

    FDA 510(k)
    FDA Class 2 ·Immunology

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 12, 2014

    FINGER PYROLYTIC CARBON PROSTHESIS

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

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

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

    EVOLUT FX DCS

    FDA Adverse Event
    Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 6, 2025

    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