BEUDAMED
    9 results · 21ms · Sources: EU EUDAMED, US FDA

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    Knee+

    FDA 510(k)
    FDA Class 2 ·Neurology

    KEOPS Balance Analyzer 3D

    FDA 510(k)
    FDA Class 2 ·Radiology

    Zoom 6F Insert Catheters

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ON-Q C-BLOC SAF/PCA, 400 X 1-7 + 5ML/60MIN

    FDA Adverse Event
    Malfunction ·I-FLOW CORP.·Product code MEB·August 24, 2011

    SURESCAN

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code GZB·November 11, 2014

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·July 23, 2013

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·February 4, 2019

    BD NEXIVA DUAL PORT 24GA 0.75IN (0.7 MM X 19 MM)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·March 13, 2019

    Voyant Open Fusion Device Models: EB040 and EB040+ Product Usage: The Applied Voyant Open Fusion Device is designed for use with the Voyant Electrosurgical Generator. The device is an advanced bipolar instrument that uses RF energy, provided by the generator, to seal vessels up to and including 5mm (EB040+) or 7mm (EB040) in diameter. The device may also be used to seal tissue bundles that can be captured in the device jaws. The system delivers the energy required to fuse the tissue between the jaws of the device by monitoring voltage and current throughout the seal cycle. The device also features a useractuated blade for the transection of sealed tissue.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Resources Corp·September 23, 2015