BEUDAMED
    8 results · 20ms · Sources: EU EUDAMED, US FDA

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    LEATHER VALVE CUTTER

    FDA 510(k)
    FDA Class 1 ·Cardiovascular

    RESTORE MODULAR STERILIZATION TRAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CONKLUSION PEDICLE SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 25, 2014

    PROPAQ MD DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS·Product code LDD·October 11, 2012

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code MDS·September 10, 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

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024