BEUDAMED
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    FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017866·K-Wire, Double Ended, Trocar Point, Diameter Si...

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017873·K-Wire, Double Ended, Trocar Point, Diameter 0....

    3M™ Unitek™

    FDA UDI
    3M UNITEK CORPORATION·00652221045416·Unitek(TM) Molar Band General Purpose Wide Regu...

    JETSTREAM G3 L SYSTEM, PV CONSOLE, MODELS PV31400, PV31300, PVCN100

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN PROGESTERONE RECEPTOR ANTIBODY (CLONE SP2)

    FDA 510(k)
    FDA Class 2 ·Hematology

    CONSULTA CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·October 10, 2014

    CARELINK

    FDA Adverse Event
    Malfunction ·RICE CREEK MFG·Product code DXY·June 10, 2013

    XCM BIOLOIGIC TISSUE MATRIX

    FDA Adverse Event
    Injury ·KENSEY NASH CORP.·Product code FTM·July 5, 2011

    Artis zeego, Model Number 10280959

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 31, 2019

    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/ zeego systems; 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·August 26, 2015

    The Artis zee / zeego Angiography System is designed as a set of components that may be combined into different configurations to provide specialized angiography systems.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·December 10, 2014

    Siemens Artis zee systems; 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 include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·August 12, 2015