BEUDAMED
    17 results · 23ms · Sources: EU EUDAMED, US FDA

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    Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent Film

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

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694014809·SpectrumTM LeFort III, Cap Nut

    ASSURE 4 BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DEFENDO Y-OPSY IRRIGATOR

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

    IPRO2 RECORDER

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code MDS·October 14, 2014

    FLEXTEND

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·July 20, 2011

    GOBED+

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·June 14, 2013

    OSTEO-SITE BONE BIOPSY NEEDLE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KNW·July 18, 2019

    OSTEO-SITE BONE BIOPSY NEEDLE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KNW·June 17, 2019

    OSTEO-SITE BONE BIOPSY NEEDLE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KNW·January 23, 2019

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code LWR·April 28, 2017

    OSTEO-SITE BONE BIOPSY NEEDLE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KNW·July 16, 2019

    OSTEO-SITE BONE BIOPSY NEEDLE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KNW·October 8, 2019

    HERMETIC LARGE STYLE VENTRICULAR CATHETER SET

    FDA Adverse Event
    Injury ·INTEGRA NEUROSCIENCES PR·Product code FPA·August 22, 2017

    OSTEO-SITE BONE BIOPSY NEEDLE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KNW·July 17, 2019

    OSTEO-SITE BONE BIOPSY NEEDLE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KNW·July 11, 2019

    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical, Cardiac Rhythm Management Division·January 22, 2020