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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    EndoTool SubQ

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BYTE DAY ALIGNERS

    FDA Adverse Event
    Malfunction ·STRAIGHT SMILE, LLC·Product code NXC·October 31, 2024

    DURACHECK BLOOD PRESSURE CUFF, MODEL ZDC4000 SERIES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDICINA ENTERAL FEEDING TUBES AND ACCESSORIES MODEL MGX/YY

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

    POSEY BED

    FDA Adverse Event
    Malfunction ·J. T. POSEY CO.·Product code OYS·October 15, 2014

    SOLYX SIS SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 20, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011

    DENALI JUGULAR SYSTEM

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 27, 2023

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    FDA Adverse Event
    Injury ·MEDTRONIC CRYOCATH LP·Product code OAE·May 2, 2018

    DENALI JUGULAR SYSTEM

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·November 21, 2023

    DENALI FEMORAL SYSTEM

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 10, 2023

    DENALI FEMORAL SYSTEM

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 6, 2023

    DENALI FEMORAL SYSTEM

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 20, 2023

    DENALI FEMORAL SYSTEM

    FDA Adverse Event
    Injury ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 11, 2023

    DENALI FEMORAL SYSTEM

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·November 7, 2023

    DENALI FEMORAL SYSTEM

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·October 20, 2023

    DENALI FEMORAL SYSTEM

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 9, 2023

    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. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014