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

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    CHEMMATE(TM) CD43

    FDA 510(k)
    FDA Class 2 ·Immunology

    Sierra

    FDA UDI
    Seaspine Orthopedics Corporation·10889981094607·Ratcheting Rod Cutter

    Biodex

    FDA UDI
    SPORT MEDICAL TECHNOLOGY INC.·00718175001486·CYCLE, UPPER BODY - CLINICAL PRO

    Terason uSmart3300 Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    MENTOR ARIS TRANS-OBTURATOR TAPE AND SURGICAL KIT

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

    SYMBIQ SINGLE CHANNE

    FDA Adverse Event
    Malfunction ·HOSPIRA, INC.·Product code FRN·December 9, 2010

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·February 8, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 22, 2014

    1820334-2020-01805

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FOZ·October 5, 2020

    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