BEUDAMED
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    Vivo 60

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    3M™ Unitek™

    FDA UDI
    3M UNITEK CORPORATION·00652221045607·Unitek(TM) Molar Band General Purpose Wide Regu...

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197060073·Hartmann cotton applicator 220mm,...

    LIBERTY GLUCOSE CONTROL SOLUTION

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SMITH & NEPHEW MDF MODULAR SLEEVE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OSSIX BONE, OSSIX PLUS

    FDA Adverse Event
    Injury ·DATUM DENTAL LTD.·Product code NPM·June 22, 2022

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·July 1, 2011

    BIPOLAR SEALER W/CUT AQM3 8.2L

    FDA Adverse Event
    Malfunction ·MEDTRONIC ADVANCED ENERGY, LLC·Product code DWG·June 10, 2013

    REMANUFACTURED I-PUMP

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code FRN·September 12, 2008

    SPECIAL EVD 10-110 W/O Y SITE

    FDA Adverse Event
    Malfunction ·INTEGRA NEUROSCIENCES PR·Product code JXG·November 22, 2016

    V.A.C. GRANUFOAM DRESSING

    FDA Adverse Event
    Injury ·KINETIC CONCEPTS, INC.·Product code OMP·May 6, 2020

    SPECIAL EVD 10-110 W/O Y SITE

    FDA Adverse Event
    Malfunction ·INTEGRA NEUROSCIENCES PR·Product code JXG·November 22, 2016

    SPECIAL EVD 10-110 W/O Y SITE

    FDA Adverse Event
    Malfunction ·INTEGRA NEUROSCIENCES PR·Product code JXG·November 22, 2016

    Artis zeego, Material no. 10280959 , for angiography and whole body radiographic/fluoroscopic procedures.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 4, 2018

    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