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

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    HC Biologics Osteopoint Spinal Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Whisper Tech Ultra-Fine Toothbrush

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·10810063756274·Whisper Tech Ultra-Fine Toothbrush, slim oval h...

    Vivid ZirDisc Zircon Zahn System

    FDA UDI
    PEARSON DENTAL SUPPLIES, INC.·D724Q2500921·95x25mm SHT (Super Translucent)

    APEX Revision Knee

    FDA UDI
    Omni Life Science, Inc.·00841690124757·Modular Stem 9mm x 125mm

    R605 FACS COLLIMETER

    FDA 510(k)
    FDA Class 2 ·Radiology

    STERISPINE PS Pedicle Screw

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ALARIS® PUMP MODULE ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code FPA·January 9, 2018

    ALARIS® PUMP MODULE ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code FPA·January 9, 2018

    INTERMATE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·November 14, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 15, 2011

    PREFYX PPS SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - SPENCER·Product code FTL·July 26, 2013

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013