BEUDAMED
    15 results · 21ms · Sources: EU EUDAMED, US FDA

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    Map-it Diagnostic Mapping Catheters

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SEEDNET, SEEDNET GOLD, CRYOHIT, CRYO THERA

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SURGIMAX/ SURGIMAX PLUS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    HAND PIECE FOR BATTERY POWERED DRIVER

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HXX·December 2, 2014

    PROTECTA XT DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·June 10, 2013

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 13, 2011

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·September 16, 2008

    AMPLATZER PICCOLO

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL·Product code MAE·August 30, 2023

    AMPLATZER PICCOLO

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL·Product code MAE·September 18, 2023

    COMP LK SCR 3.5HEX 4.75X25 ST

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·September 19, 2022

    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 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