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

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    3MP Color LCD Monitor, RadiForce RX350

    FDA 510(k)
    FDA Class 2 ·Radiology

    AGC KNEE SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304222106·

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111057922·SKLHN HI LVL BAND SCISS 5 1/2"

    BINAXNOW COVID-19 ANTIGEN SELF TEST

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·August 23, 2021

    BINAXNOW COVID-19 ANTIGEN SELF-TEST

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCABOROUGH·Product code QKP·August 27, 2021

    INTERMEZZO PLUS FIXTURE

    FDA 510(k)
    FDA Class 2 ·Dental

    EBONY PTA .035 PERIPHERAL DILATATION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BINAXNOW¿ COVID-19 ANTIGEN SELF TEST

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·August 19, 2021

    BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·July 22, 2022

    NEXIVA DIFFUSICS

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·March 30, 2026

    SOLIS CERVICAL CAGE SIZE H 6 MM L 14 MM

    FDA Adverse Event
    Malfunction ·STRYKER SPINE-FRANCE·Product code MAX·August 4, 2015

    VIRTUOSO DR

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

    SINGLE EXTENSION

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 30, 2011

    WALLSTENT RX BILIARY ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC·Product code FGE·September 5, 2008

    Artis zee biplane, Model Number 10094141

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

    ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

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

    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