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

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    AGILITY

    FDA 510(k)
    FDA Class 2 ·Radiology

    SET, ADMINISTRATION, INTRAVASCULAR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·June 6, 2016

    CASCADIA™ Interbody System

    FDA UDI
    VB Spine LLC·10888857554627·Trial Size 14x18x13 mm, Convex

    SAPPHIRE NC

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    IRRIGATION SETS

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

    PROSOUND F75 ULTRASOUND SCANNER

    FDA Adverse Event
    Malfunction ·HITACHI ALOKA MEDICAL, LTD·Product code GXX·July 16, 2014

    9610847-2018-00381

    FDA Adverse Event
    Malfunction ·November 9, 2018

    ADJUSTMENT BLOCK - STANDARD

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS-MAHWAH·Product code LXH·May 22, 2013

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - AIBONITO·Product code FPA·June 14, 2011

    BIPOL LEAD MODEL 300

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·August 15, 2008

    CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000.

    FDA Enforcement
    Class II ·Terminated·Cardiovascular Systems Inc·May 31, 2017