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

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    INSPIREASE

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    VITAL SIGNS MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CD HORIZON (ADDITION OF SPINOUS PROCESS PLATE)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    STYLE 110 SILICONE GEL FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FTR·June 15, 2023

    ARIS TRANS-OBUTRATOR

    FDA Adverse Event
    Injury ·COLOPLAST A/S·Product code FTL·February 7, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 14, 2012

    INFINITI VISION SYSTEM OZIL

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·September 3, 2010

    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