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

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    FLO-GARD(R) 6201

    FDA 510(k)
    FDA Class 2 ·General Hospital

    LABSONICS MAMM-O-MATE MODEL NO. 918084-1, MODIFIED

    FDA 510(k)
    FDA Class 2 ·Radiology

    ARTHROBOT(TM) WRIST HOLDER ACCESSORY

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    CONSTELLATION VISION SYSTEM

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·June 4, 2014

    ATB ADVANCE BALLOON CATHETER

    FDA Adverse Event
    Injury ·COOK, INC.·Product code DQY·January 9, 2013

    ULTRACISION HARMONIC SCALPEL HAND PIECE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code LFL·February 2, 2008

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015