BEUDAMED
    22 results · 26ms · Sources: EU EUDAMED, US FDA

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    Fusion Bx

    FDA 510(k)
    FDA Class 2 ·Radiology

    MIS

    FDA UDI
    Zimmer, Inc.·00889024572980·

    SINCLAIR ORAL RINSE

    FDA 510(k)
    FDA Class 2 ·Dental

    CHEETAH RELIANT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FORMATK MAGMA PLATFORM LASER

    FDA Adverse Event
    Injury ·FORMATK SYSTEMS LTD.·Product code GEX·December 19, 2019

    FORMATK MAGMA PLATFORM

    FDA Adverse Event
    Malfunction ·FOMATK SYSTEMS, LTD·Product code GEX·January 8, 2020

    CONSULTA CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 8, 2013

    NEXGEN MIS STEMMED TIBIAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER INC·Product code JWH·June 23, 2011

    POLYFLUX LR CAPILLARY DIALYZER

    FDA Adverse Event
    Malfunction ·GAMBRO DIALYSATOREN GMBH·Product code MSF·September 4, 2008

    VALIANT STENT GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·August 24, 2015

    TALENT TAA STENT GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR SANTA ROSA·Product code MIH·August 24, 2015

    ARCHITECT HBSAG

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND·Product code KSJ·September 1, 2015

    ARCHITECT HBSAG QUALITATIVE II

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND·Product code KSJ·December 15, 2017

    ARCHITECT HBSAG

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LOM·December 30, 2025

    ARCHITECT HBSAG

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LOM·June 23, 2025

    ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    Artis zee biplane, Model Number 10094141

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

    Artis zee biplane, Model Number 10094141

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

    Artis zee/ zeego systems; Product Usage: Usage: Artis zee/ zeego systems are 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·July 1, 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