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

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    Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776393199·Hibbs Gouge, 9 1/2", curved, 3/4"

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780188643·Integra® Jarit® Hibbs Gouge, 9-1/2", Curved, 3/4"

    JUVENILE TUMOR SYSTEM (JTS)

    FDA Adverse Event
    Injury ·ONKOS SURGICAL·Product code KRO·August 12, 2025

    AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES

    FDA 510(k)
    FDA Class 2 ·Neurology

    Procedure mask/Surgical mask/Face mask

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    NIM-ECLIPSE® CONTROLLER

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED, INC·Product code GWF·December 9, 2014

    INTERMATE

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

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 15, 2011

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·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