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

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    Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra Optia AC Connection Adapter

    FDA 510(k)
    FDA Unclassified ·Unknown

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517575388·CoRoent Ant TLIF Ti, 15x11x36mm 8°

    BR 102 PLUS BLOOD PRESSURE HOLTER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    D. HEART MEDICAL INTRAVASCULAR ADMINISTRATION SET, SAFETY ACCES DEVICE AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·June 7, 2013

    TOTAL ABSCESSION DRAINAGE CATHETER

    FDA Adverse Event
    Malfunction ·ANGIODYNAMICS·Product code GBX·June 8, 2011

    CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code LWR·September 3, 2008

    C-QUR MOSAIC

    FDA Adverse Event
    Injury ·ATRIUM MEDICAL CORPORATION·Product code FTL·October 9, 2015

    Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 9, 2014