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

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    ETHOX SURGI-CUF ADULT DISPOSABLE BLOOD PRESSURE CUFFS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496040286·MISS RELAX MICRO RETE 70 SHEER, SIZE M, AVORIO,...

    TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BRAHMS DIAGNOSTICA LUMITEST ANTI-TG

    FDA 510(k)
    FDA Class 2 ·Immunology

    TRIAGE CARDIAC TRIPLE MARKER PANEL

    FDA Adverse Event
    Malfunction ·QUIDEL CARDIOVASCULAR INC.·Product code MMI·October 12, 2018

    TRIAGE CARDIAC HS PANEL

    FDA Adverse Event
    Malfunction ·QUIDEL CARDIOVASCULAR INC.·Product code MMI·October 22, 2019

    TRIAGE CARDIAC TRIPLE MARKER PANEL

    FDA Adverse Event
    Malfunction ·QUIDEL CARDIOVASCULAR, INC.·Product code MMI·May 18, 2018

    TRIAGE CARDIAC PANEL KIT

    FDA Adverse Event
    Malfunction ·QUIDEL CARDIOVASCULAR, INC.·Product code JHX·April 18, 2018

    TRIAGE CARDIAC HS PANEL

    FDA Adverse Event
    Malfunction ·QUIDEL CARDIOVASCULAR INC.·Product code MMI·October 21, 2019

    TRIAGE CARDIAC TRIPLE MARKER PANEL

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code MMI·October 5, 2017

    PROLENE POLYPROPYLENE MESH

    FDA Adverse Event
    Injury ·ETHICON, INC·Product code FTL·April 8, 2013

    KNIFE

    FDA Adverse Event
    Malfunction ·ALCON PRECISION DEVICE - SINKING SPRING·Product code HNN·February 15, 2011

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    FDA Adverse Event
    Injury ·STAAR SURGICAL·Product code HQL·May 8, 2008

    TRIAGE CARDIAC TRIPLE MARKER PANEL

    FDA Adverse Event
    Malfunction ·QUIDEL CARDIOVASCULAR INC.·Product code MMI·November 1, 2018

    TRIAGE CARDIAC TRIPLE MARKER PANEL

    FDA Adverse Event
    Injury ·ALERE SAN DIEGO, INC.·Product code MMI·May 17, 2017

    BD LUER-LOK¿ SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·March 31, 2022

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012