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

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    SILEX SACROILIAC JOINT FUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    N.A.

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011123702000·Adhesive residue remover, pear shaped, large

    FOTONA XP ND: YAG LASER SYSTEM

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

    POWDER-FREE NITRILE EXAM GLOVES, COLOR: BLUE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC (IRWINDALE)·Product code OAD·May 11, 2012

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 22, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·September 26, 2014

    CONCERTO CRT-D DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·June 14, 2011

    LASSO

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC. (IRWINDALE)·Product code DRF·December 21, 2016

    NAVISTAR® THERMOCOOL® ELECTROPHYSIOLOGY CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code OAD·October 22, 2014

    THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code LPB·September 29, 2016

    PATIENT INFORMATION CENTER IX

    FDA Adverse Event
    Death ·PHILIPS MEDICAL SYSTEMS·Product code MHX·March 15, 2023

    PATIENT INFORMATION CENTER IX

    FDA Adverse Event
    Death ·PHILIPS MEDICAL SYSTEMS·Product code MHX·November 9, 2023

    Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

    FDA Enforcement
    Class II ·Ongoing·Electro Medical Systems SA·May 1, 2024