BEUDAMED
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    MCP Bone Putty

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613084875·K-Wire, Double Ended, Trocar Point, Diameter 0....

    ROCHE ORAL FLUID AMPHETAMINE, ROCHE ORAL FLUID DAT QUAL CAL B, ROCHE ORAL FLUID DAT CONTROL SET B, AND ROCHE ORAL FLUID

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    CIRCUFLOW 5100 SEQUENTIAL COMPRESSION DEVICE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PENUMBRA MAX PUMP - INDIGO SYSTEM

    FDA Adverse Event
    Malfunction ·PENUMBRA INC., USA·Product code NRY·August 23, 2018

    PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code NRY·March 8, 2018

    PENUMBRA SYSTEM ASPIRATION PUMP MAX 220

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code NRY·April 9, 2018

    ESPRIT VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code CBK·July 13, 2011

    PERMANENT CAUTERY SPATULA INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·June 10, 2013

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 16, 2008

    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