BEUDAMED
    11 results · 30ms · Sources: EU EUDAMED, US FDA

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    GC85A

    FDA 510(k)
    FDA Class 2 ·Radiology

    BAROSTAT SOFTWARE OPTION

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

    SNAP II EEG MONITOR

    FDA 510(k)
    FDA Class 2 ·Neurology

    ATTAIN ABILITY

    FDA Adverse Event
    Malfunction ·MPRI·Product code OJX·October 10, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013

    ALLEGRETTO WAVE EYE-Q

    FDA Adverse Event
    Malfunction ·WAVELIGHT GMBH·Product code LZS·June 16, 2011

    CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code DYB·August 31, 2021

    CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code DYB·June 8, 2021

    Artis zeego, Model Number 10280959

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

    Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese patients. Procedures that can be performed with the AXIOM Artis-zee/zeego and Q/Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee/zeego and Q/Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 6, 2017

    Artis zee Biplane, Model No. 10094141; Artis zee Ceiling, Model No. 10094137; Artis zee Floor, Model No. 10094135; Artis zeego, Model No. 10280959 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·March 25, 2020