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

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    SALVATION(R) External Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CONTINUOUS NEBULIZATION TUBE SET (CNTS) TUBING: AG-AS3075 + SYRINGE: AG-AS3085; CONTINOUS NEBULIZATION TUBE SET (CNTS) S

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MODIFICATION TO RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·October 8, 2014

    REVEAL XT

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code DSI·June 8, 2013

    TELIGEN

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 7, 2011

    ARNDT ENDOBRONCHIAL BLOCKER SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code CBI·November 20, 2018

    PHOTOFIX PATCH - 6CM X 8CM

    FDA Adverse Event
    Injury ·CRYOLIFE, INC. - KENNESAW·Product code PSQ·January 12, 2021

    VERSAFITCUP CC TRIO ACETABULAR SHELL Ø 56

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·January 18, 2017

    VERSAFITCUP CC TRIO ACETABULAR SHELL

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·August 3, 2017

    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

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

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

    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