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

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    TAS HMT CONTROLS

    FDA 510(k)
    FDA Class 2 ·Hematology

    OVENT

    FDA 510(k)
    FDA Class 2 ·Dental

    MCCUE ENERGIST ULTRA VPL INTENSE PULSE LIGHT SYSTEM

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

    PERIGEE SYSTEM

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code OTP·February 8, 2013

    QUILL SRS

    FDA Adverse Event
    Other ·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·January 5, 2011

    GRANUFLO

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·July 18, 2014

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

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