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

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    COAT-A-COUNT IRMA FERRITIN KIT AND ITS COMPONENTS

    FDA 510(k)
    FDA Class 2 ·Immunology

    Surgi Max Ultra

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PARI HYDRATE G

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·June 12, 2014

    DUROM ACETABULAR COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·October 11, 2010

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

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

    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

    Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024