BEUDAMED
    7 results · 20ms · 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.
    Filters Regulation: Us FDA ×

    CURITY 100% SILICONE IRRIGATION FOLEY

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

    BLOOD OXYGENATION LEVEL DEPENDENT (BOLD) OPTION

    FDA 510(k)
    FDA Class 2 ·Radiology

    ONE PERSONAL LUBRICANT (WATER BASED)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 9, 2014

    GEM II VR

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code LWS·October 31, 2012

    BIOSENSE WEBSTER CATHETER, DUO DECA LASSO CATHETER

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER·Product code DRF·August 16, 2010

    TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·May 20, 2015