BEUDAMED
    13 results · 31ms · Sources: EU EUDAMED, US FDA

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    Imagio Ultrasound Imaging System

    FDA 510(k)
    FDA Class 2 ·Radiology

    CMR42 CARDIAC MRI IMAGING SYSTEM, 2.1.23

    FDA 510(k)
    FDA Class 2 ·Radiology

    NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    LINEAR 7.5 FR. 25CC IAB

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·October 17, 2019

    LINEAR 7.5 FR. 25CC IAB

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·October 17, 2019

    BD LUER-LOK SYRINGE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·September 30, 2020

    I-STAT EC8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·March 6, 2019

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 17, 2014

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·July 5, 2011

    COBAS 6000 C501MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·June 21, 2013

    SENSATION PLUS 7.5FR. 40CC IAB

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·February 23, 2021

    SENSATION PLUS 7.5FR. 40CC IAB

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·January 4, 2022

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021